Recalls in December 2012

NHTSA received 45 vehicle recall campaigns in December 2012. NHTSA also received 3 child seat, tire or equipment campaigns. The NHTSA campaigns have 1,792,949 units in total. 31 CPSC recalls have a recall date in the month, with about 1,247,462 units. FDA enforcement reports of the month have 141 events.

Counts

NHTSA vehicle campaigns: 45November 2012: 25
NHTSA child seat, tire and equipment campaigns: 3
Units in the NHTSA campaigns: 1,792,949
CPSC product recalls: 31November 2012: 33
FDA enforcement events: 141November 2012: 171

Download all recalls of December 2012 (CSV)

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NHTSA

Vehicles, child seats, tires and equipment.

NHTSA recall campaigns that NHTSA received in December 2012, newest first
Received	Campaign	First vehicle or product	Component	Type	Manufacturer	Units
28 Dec 2012	12E057000	Duralast Brake Rotor	Equipment	Equipment	Neotek Corporation, Inc.	10,626
26 Dec 2012	12V600000	Prevost X3-45 2011 and 1 more	Suspension	Vehicle	Prevost Cars, Inc.	196
26 Dec 2012	12V602000	Subaru Forester 2009 and 14 more	Exterior Lighting	Vehicle	SUBARU OF AMERICA, INC.	633,842
21 Dec 2012	12V599000	Keystone Springdale 2012 and 1 more	Equipment	Vehicle	KEYSTONE RV COMPANY	191
21 Dec 2012	12V601000	Freightliner Coronado 2012 and 1 more	Equipment	Vehicle	Daimler Trucks North America	515
20 Dec 2012	12E056000	Vega XTS	Equipment	Equipment	Vega Helmet Corporation	14,109
20 Dec 2012	12V596000	Airstream Interstate 2008 and 5 more	Electrical System	Vehicle	Airstream, Inc.	576
20 Dec 2012	12V597000	Suzuki XL7 2007	Fuel System, Gasoline	Vehicle	American Suzuki Motor Corp.	2,830
20 Dec 2012	12V598000	Jerr-DAN 50 TON Wrecker 2009 and 3 more	Equipment	Vehicle	Jerr-Dan Corporation	37
19 Dec 2012	12E055000	HY-Rail HR4000 Series B Unit and 1 more	Equipment	Equipment	Harsco Rail	76
19 Dec 2012	12V594000	Chevrolet Colorado 2011 and 5 more	Latches/Locks/Linkages	Vehicle	General Motors LLC	118,800
18 Dec 2012	12V593000	Champion Challenger 2012 and 15 more	Equipment	Vehicle	Champion Bus, Inc.	73
17 Dec 2012	12V588000	Autocar Xpeditor 2012 and 1 more	Wheels	Vehicle	AUTOCAR, LLC	222
17 Dec 2012	12V591000	New Flyer DE40LFR 2009 and 36 more	Structure	Vehicle	New Flyer Industries Ltd.	2,048
14 Dec 2012	12V585000	BMW S 1000 RR 2012 and 1 more	Structure	Vehicle	BMW of North America, LLC	2,385
14 Dec 2012	12V587000	Taylor-Dunn Trident LSV 2011	Steering	Vehicle	Taylor-Dunn Manufacturing Company	15
13 Dec 2012	12V586000	Blue Bird Vision 2013	Steering	Vehicle	Blue Bird Body Company	222
12 Dec 2012	12V581000	CAN-AM Spyder GS 2009 and 2 more	Fuel System, Gasoline	Vehicle	Bombardier Recreational Products Inc.	9,600
12 Dec 2012	12V582000	CAN-AM Spyder RT 2011 and 8 more	Fuel System, Gasoline	Vehicle	Bombardier Recreational Products Inc.	33,700
12 Dec 2012	12V584000	Ford E-450 2007 and 10 more	Equipment	Vehicle	Creative Bus Sales, Inc.	227
11 Dec 2012	12V570000	Thomas Built SAF-T-Liner C2 2011 and 2 more	Engine and Engine Cooling	Vehicle	Daimler Trucks North America	6,296
11 Dec 2012	12V572000	Thomas Built Buses SAF-T-Liner C2 2011 and 2 more	Engine and Engine Cooling	Vehicle	Daimler Trucks North America	42
11 Dec 2012	12V573000	Honda Odyssey 2004 and 7 more	Electrical System	Vehicle	Honda (American Honda Motor Co.)	807,161
11 Dec 2012	12V574000	Thor Motor Coach Tuscany 2013 and 6 more	Vehicle Speed Control	Vehicle	Thor Motor Coach	727
11 Dec 2012	12V576000	Sterling 360 2007	Fuel System, Other	Vehicle	Daimler Trucks North America	1,601
11 Dec 2012	12V578000	Newmar Dutch Star 2013 and 8 more	Vehicle Speed Control	Vehicle	Newmar Corporation	626
11 Dec 2012	12V592000	Triumph Trophy 2013	Equipment	Vehicle	TRIUMPH MOTORCYCLES AMERICA LTD	244
10 Dec 2012	12V575000	Winnebago Aspect 2008	Equipment	Vehicle	Winnebago Industries Inc.	1
10 Dec 2012	12V577000	Champion CX380 2013 and 5 more	Vehicle Speed Control	Vehicle	CHAMPION BUS, INC.	49
10 Dec 2012	12V579000	Spartan Metrostar 2012 and 5 more	Visibility/Wiper	Vehicle	Spartan Chassis, Inc.	36
10 Dec 2012	12V580000	Glaval Sport 2011 and 47 more	Equipment	Vehicle	Glaval Bus Division	704
7 Dec 2012	12V567000	Hyundai Veloster 2012	Parking Brake	Vehicle	Hyundai Motor Company	4,490
7 Dec 2012	12V568000	Hyundai Veloster 2012	Visibility	Vehicle	Hyundai Motor Company	13,500
7 Dec 2012	12V569000	Coach & Equipment Phoenix 2007 and 8 more	Equipment	Vehicle	Coach and Equipment Mfg Corp.	337
7 Dec 2012	12V571000	Jaguar XF 2013	Electrical System	Vehicle	Jaguar Land Rover North America, LLC	9
6 Dec 2012	12V563000	Land Rover LR2 2012 and 1 more	Service Brakes, Hydraulic	Vehicle	Jaguar Land Rover North America, LLC	70
6 Dec 2012	12V564000	Prevost X3-45 2011 and 1 more	Equipment	Vehicle	Prevost Cars, Inc.	87
6 Dec 2012	12V565000	Spartan K3 2013 and 2 more	Service Brakes, Air	Vehicle	Spartan Chassis, Inc.	23
6 Dec 2012	12V566000	Itasca Meridian 2010 and 15 more	Electrical System	Vehicle	Winnebago Industries Inc.	1,521
4 Dec 2012	12V560000	Dodge Durango 2013	Equipment	Vehicle	Chrysler Group LLC	734
4 Dec 2012	12V561000	Lamborghini Aventador 2012	Exterior Lighting	Vehicle	AUTOMOBILI LAMBORGHINI	144
3 Dec 2012	12V551000	Ford Escape 2013 and 1 more	Engine and Engine Cooling	Vehicle	Ford Motor Company	80,057
3 Dec 2012	12V555000	Hino NB6J 2010 and 71 more	Electrical System	Vehicle	HINO MOTORS SALES U.S.A., INC.	35,142
3 Dec 2012	12V556000	BMW C600 Sport Maxi-Scooter 2013	Structure	Vehicle	BMW of North America, LLC	266
3 Dec 2012	12V557000	Mercedes-Benz E350 2012 and 15 more	Fuel System, Gasoline	Vehicle	Mercedes-Benz USA, LLC.	5,800
3 Dec 2012	12V558000	Porsche 911 GT3 2010	Wheels	Vehicle	PORSCHE CARS NORTH AMERICA, INC.	455
3 Dec 2012	12V559000	Itasca Reyo 2013 and 22 more	Electrical System	Vehicle	WINNEBAGO INDUSTRIES INC.	2,495
3 Dec 2012	12V562000	Ford F-650 2011 and 3 more	Equipment	Vehicle	Phenix Enterprises, Inc.	42

A campaign that names 2 or more vehicles has a link to the first vehicle. The page of that vehicle shows the campaign in full.

Recall campaign: One recall in the NHTSA recall file, with one campaign number. A campaign can name many makes, models and model years.

Units: The number of vehicles or products that a recall can include. The manufacturer or the firm reports the number to the agency.

CPSC

Consumer products.

CPSC recalls with a recall date in December 2012
Date	Recall	Firm	Category	Hazard	Units	CPSC number
27 Dec 2012	Meijer Recalls Falls Creek Kids Denim Jeans Due to Choking Hazard	Dye Knittingly	Clothing (Children)	Choking, Fall	140,500	13084
27 Dec 2012	Four Retailers Agree to Stop Sale and Voluntarily Recall Nap Nanny Recliners Due to Five Infant Deaths	Baby Matters	Baby Seats (Non-Bath)		155,000	13083
26 Dec 2012	Bethlehem Lights Recalls Christmas Trees Sold Exclusively by QVC Due to Fire Hazard	GKI Bethlehem Lights	Seasonal Decoration	Fire, Overheating	15,500	13714
26 Dec 2012	American Honda Expands Recall of FourTrax ATVs Due to Crash Hazard	American Honda Motor	All Terrain Vehicles (ATV)	Crash	19,500	13713
20 Dec 2012	PAPYRUS Signature Collection Frames Recalled Due to Risk of Exposure to Mold	Idianale Inc./Dekokraft	Seasonal Decoration	Mould or bacteria	105	13082
20 Dec 2012	PAPYRUS Signature Collection Red 17-Inch Decorative Trees Recalled Due to Risk of Exposure to Mold	Idianale Inc./Dekokraft	Seasonal Decoration	Mould or bacteria	455	13081
20 Dec 2012	PAPYRUS Signature Collection Ornaments Recalled Due to Risk of Exposure to Mold	Idianale Inc./Dekokraft	Seasonal Decoration	Mould or bacteria	45,500	13080
20 Dec 2012	Sassy and Carter's-branded Hug N’ Tug Baby Toys Recalled Due to Choking Hazard	Sassy	Toy Figures	Choking	45,300	13079
20 Dec 2012	Muddy Outdoors Recalls Climbing Sticks Due to Risk of Serious Injury or Death	Classic Asia Group	Hunting Accessories		1,500	13078
19 Dec 2012	Arctic Cat Recalls Bearcat Snowmobiles Due to Fire Hazard	Arctic Cat	Snowmobiles	Fire	3,900	13712
19 Dec 2012	Canon Recalls for Repair Wireless File Transmitter Due to Risk of Allergic Reaction	Canon	Computer Equipment	Lead or chemical	500	13076
18 Dec 2012	Polaris Recalls Pro-RMK Snowmobiles Due to Injury, Death Hazard	Polaris Industries	Snowmobiles	Electric shock	82	13711
18 Dec 2012	Bicycles Recalled by Wilier Triestina Due to Fall Hazard; Bicycle Fork's Steerer Tube Can Break	Wilier Triestina	Bicycles & Accessories	Fall	200	13075
18 Dec 2012	Norco Recalls Havoc Bicycles Due to Risk of Injury	Norco Bicycles, a division of LTP Sports Group Inc., of Port Coquitlam, British Columbia, Canada	Bicycles & Accessories		90	13074
18 Dec 2012	LG Recalls Top-Loading Washing Machines Due to Risk of Injury	LG Electronics	Washing Machines		457,000	13073
18 Dec 2012	Catalina Outdoor Fireplace Recalled by Christmas Tree Shops Due to Burn and Laceration Hazard	Nantucket Distributing	Fireplaces & Accessories	Fire, Burn, Laceration	2,000	13072
17 Dec 2012	Dunecraft Recalls Water Balz, Skulls, Orbs and Flower Toys Due to Serious Ingestion Hazard	Dunecraft	Toys	Poisoning	94,700	13071
13 Dec 2012	Mattresses Recalled by Easy-Rest Due to Violation of Federal Mattress Flammability Standard	Easy-Rest	Mattresses	Fire, Violation of standard	3,800	13069
13 Dec 2012	American Mattress Manufacturing Recalls Renovated Mattresses Due to Violation of Federal Flammability Standard	American Mattress Manufacturing	Mattresses	Fire, Violation of standard	1,500	13068
13 Dec 2012	Enesco Recalls Shelly's Diner Collectible Due to Fire Hazard	Enesco	Collectibles	Fire, Overheating	1,600	13067
12 Dec 2012	City Versa Strollers Recalled by Baby Jogger Due to Fall Hazard	Baby Jogger	Strollers	Fall	8,400	13065
11 Dec 2012	Fu San Machinery Recalls Low Lead Ball Valves Installed in Flammable Gas Lines Due to Fire and Explosion Hazards	Fu San Machinery	Gas Control Valves	Fire, Lead or chemical, Explosion	163,000	13064
11 Dec 2012	Wing Enterprises Recalls Switch-it Stepladder/Stepstools Due to Fall Hazard; Sold exclusively at Home Depot	Suzhou Zhongchuang Aluminum Products	Stepladders	Fall	20,000	13063
10 Dec 2012	High-Powered Magnet Sets Recalled by Reiss Innovations Due to Ingestion Hazard; Sold Exclusively on Amazon.com	Global Goler	High-Powered Magnets	Poisoning	500	13062
6 Dec 2012	Grandin Road Recalls Chairs Due to Fall Hazard	K&K Exporters of Bareilly, Uttar Pradesh, India	Chairs	Fall	2,200	13710
6 Dec 2012	Cybex International Recalls Leg Press Due to Risk of Injury	Cybex International	Exercise Machines/Equipment		430	13709
6 Dec 2012	Dream On Me Recalls Bath Seats Due to Drowning Hazard	Dream On Me	Bathtubs & Seats (Baby)	Drowning, Tip-over	50,000	13061
6 Dec 2012	Dream On Me Recalls Children's Bed Rails Due to Suffocation and Strangulation Hazards	Dream On Me	Bed Rails	Strangulation, Suffocation, Entrapment	900	13060
6 Dec 2012	Ridgid Pneumatic Nailers Recalled by One World Technologies Due to Laceration or Injury Hazard; Sold Exclusively at the Home Depot	De Poan Pneumatic	Nailers	Laceration	8,400	13059
4 Dec 2012	Home Depot Recalls Homer's All-Purpose Bucket Mug Due to Fire Hazard	Home Depot	Mugs	Fire	3,700	13056
4 Dec 2012	Gas Fireplace Inserts Recalled by Jotul North America Due to Electrical Shock and Burn Hazards	Jotul North America	Gas-Burning Fireplaces	Burn, Electric shock	1,200	13055

FDA

Food, drugs and devices.

79 device, 42 food, 20 drug. 97 Class II, 33 Class I, 11 Class III.

FDA enforcement events with a report date in December 2012
Initiated	Product (first record)	Recalling firm	Type	Class	Records
13 Dec 2012	Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA…	Watson Laboratories Inc	Drug	Class III	1
7 Dec 2012	Yellow rice mixes with the following g brand names: (1) Shurfine brand Yellow Rice with Saffron, NET WT 5 OZ (142g), distributed by TOPCO ASSOCIATES, LLC, 7711 GROSS POINT ROAD, SKOKIE, IL 60077. UPC 011161159834 and (2) Hannaford brand Yellow Rice with real saffron & other seasonings, NET WT. 5 OZ (142g),…	Riviana International, Inc	Food	Class II	1
4 Dec 2012	Clean & Clear advantage, 3-in-1 foaming wash 8 FL. OZ. (240 mL) bottle, OTC, Distributed in the US by: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. Skillman, NJ 08558-9418 NDC 58232-0326-8 Event 63787	Name withheld	Drug	Class III	1
3 Dec 2012	Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS… Event 63777	Name withheld	Device	Class II	1
3 Dec 2012	SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is…	DePuy Orthopaedics, Inc.	Device	Class II	20
30 Nov 2012	Pure Apricot Pecan Flats, 10 units/case, 6oz. UPC 8 73376 00303.	Unified Grocers Inc.	Food	Class III	1
29 Nov 2012	Meatless Burger: 1) Veggie Patch Ultimate Meatless Burger - Net Wt. 9 oz. tray, UPC Code 6-10129-00211-5; 2) Veggie Patch The Ultimate Meatless Burger - Le burger sans-viande ultime, Net Wt 1.02Kg/ 2.25 Lb, UPC Code: 6-10129-08477-7	Tribe Mediterranean Foods Inc.	Food	Class I	2
28 Nov 2012	Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard carton, labeled and shrink-wrapped. PINNACLE CANCELLOUS Bone Screws are ancillary fixation devices used in total hip…	DePuy Orthopaedics, Inc.	Device	Class II	1
28 Nov 2012	#122-A, Piazza Produce Clam Base, Net Weight 16 oz (1 lb) 454G Packed For: Piazza Produce, Indianapolis, IN 46268: #122-A, Primarque Clam Base, Net Wt 16 oz (1 lb) 454 grams Manufactured for Primarque Products Co. Worcester, MA 01610 #122-A, Clam Base, Cook's Delight Clam Base, Net WT.16 oz (1 pound) and 50 Lb tub…	Williams West & Witt's Products Company	Food	Class II	13
26 Nov 2012	CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, during transfer through the staining process. The rack can hold up to 10 slides at a time, and is necessary for optimal CoverStainer instrument performance.	Dako Denmark A/S	Device	Class II	1
23 Nov 2012	Newman's Own Lite Honey Mustard Dressing, 16 FL.OZ (473 mL) Event 63748	Newman'S Own Inc.	Food	Class I	1
21 Nov 2012	24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.	Terumo Cardiovascular Systems Corporation	Device	Class II	7
21 Nov 2012	Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6.	Taro Pharmaceuticals U.S.A., Inc.	Drug	Class II	1
21 Nov 2012	Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01	Hospira, Inc.	Drug	Class II	1
21 Nov 2012	Apple Lattice Pie (9-inch, 36oz). Pies are sealed in a brown cardboard box with a see-through plastic label and sold as a fresh item at the consumer level. Event 63766	Name withheld	Food	Class I	1
21 Nov 2012	Sara Lee Butter Streusel Coffee Cake, Net Wt. 11.5 oz ; 8 cakes per 5.75 lb case; Distributed by Sara Lee Corp., Downers Grove, IL 60515 U.S.A.; UPC: 032100023429 Event 63736	Hillshire Brands Company	Food	Class I	1
21 Nov 2012	Tak Shing Hong Dried Taiwan Shrimp, all sizes Event 63848	Grand Products Inc.	Food	Class I	1
20 Nov 2012	WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central or Peripheral Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to…	ConMed Corporation	Device	Class II	4
20 Nov 2012	Sukhi's Gourmet Indian Food; Red Curry Vegetables; 9 oz. package. Manufactured by Jagpreet Enterprises dba Sukhi's Gourmet Indian Foods; Hayward, CA 94545 Event 63770	Jagpreet Enterprises Inc.	Food	Class I	1
19 Nov 2012	Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s): Individual Patient Circuit - catalog # 902 Patient Circuit Kit - catalog # 937: contains 2 circuits and 2 x 2.5 & 2 x 3.5 LifePort… Event 63710	Bunnell, Inc.	Device	Class I	1
19 Nov 2012	COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100 OPERATION:9000 QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and…	Zimmer, Inc.	Device	Class II	2
19 Nov 2012	AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.	BioHorizons Implant Systems Inc	Device	Class II	2
18 Nov 2012	Almondine Wedding Cookies sold by the pound.	Whole Foods Market South Seafood Distribution	Food	Class I	2
16 Nov 2012	DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.	DePuy Mitek, Inc., a Johnson & Johnson Co.	Device	Class II	1
16 Nov 2012	Chicken of the Sea Solid White Tuna in Water, 7 oz., 48 cans per case (case: 6 sets of multi-unit packs of 8 cans each), UPC 4800000097, case UPC 4800076127.	Tri-Union Seafoods, L.L.C dba Chicken of the Sea.	Food	Class I	1
16 Nov 2012	Dried Apricots 6 oz UPC 7203670494	Whole Alternatives Llc	Food	Class I	2
15 Nov 2012	EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation Event 63824	Name withheld	Device	Class II	1
15 Nov 2012	Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both primary and revision applications.…	Biomet, Inc.	Device	Class II	1
15 Nov 2012	Turkana Valley Dried Apricot 250 g, UPC 8692594007804 and 500 g UPC 8692594007811 Tunas Gida, San Ve Tic. Ltd. Sti 2 Org. San. Bol. Celal Dogan Bulvari No.:3 Baspinar Gaziantep/ Turkey packaged in plastic container	Turkana Food Inc.	Food	Class I	1
14 Nov 2012	Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COHB, MetHb), and oxygen saturation (SO2).…	Roche Diagnostics Operations, Inc.	Device	Class II	1
14 Nov 2012	Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No. RTU-TdT-339; packaged in 7 mL vials; Leica…	Leica Microsystems, Inc.	Device	Class II	1
14 Nov 2012	100/120V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is…	Terumo Cardiovascular Systems Corporation	Device	Class II	2
14 Nov 2012	Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is…	Siemens Healthcare Diagnostics, Inc	Device	Class II	7
14 Nov 2012	Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or…	Zimmer, Inc.	Device	Class II	17
14 Nov 2012	Berres Brothers Coffee Roasters Chocolate & Peanut Butter regular whole bean coffee packaged in the following sizes: 12 oz. (340g) UPC 746774-003594 and 5 LB bulk, UPC 746774-00499.	Berres Brothers, Inc.	Food	Class I	10
13 Nov 2012	The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and…	Medtronic Navigation, Inc.	Device	Class II	1
12 Nov 2012	SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD touch screen that displays treatment time, positioning and magnitude and direction of motion. There are eight fully customizable Patient Protocol settings for commonly used… Event 63788	BioMotion Medical Systems, LLC	Device	Class II	1
10 Nov 2012	Jimmy Dean French Toast & Sausage Sandwich, Net Wt 3.9 oz (110g); a food service individually butcher paper wrapped, fully cooked frozen sandwich; 12 sandwiches per 2.74 lb case; UPC 54500 51434 Event 63666	Hillshire Brands Company	Food	Class I	1
9 Nov 2012	Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other…	Philips Healthcare Inc.	Device	Class II	1
9 Nov 2012	SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated for use when patient therapy requires the…	Name withheld	Device	Class I	2
9 Nov 2012	EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.	Biomet, Inc.	Device	Class II	1
9 Nov 2012	Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, India, NDC #: 63304-827-90	Ranbaxy Inc.	Drug	Class II	3
8 Nov 2012	Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D This custom pack includes components necessary for a specific procedure.	Medline Industries Inc	Device	Class II	1
8 Nov 2012	Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor and Gamble, Cincinnati, OH 45040. NDC 37000-808-12	Procter & Gamble Co	Drug	Class II	1
8 Nov 2012	Organic Gelato Chocolate Peanut Butter, 5 liter, contained in plastic packaging, manufactured by Fresca Foods, CO.	Name withheld	Food	Class I	5
8 Nov 2012	Nesquik Chocolate Powder, 1) 6x40.7oz, UPC 0 28000 68230 9. 2) 12x21.8oz, UPC 0 28000 68090 9. 3) 12x10.9oz, UPC 0 28000 67990 3.	Nestle USA	Food	Class I	1
6 Nov 2012	Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck…	Biomet, Inc.	Device	Class II	1
6 Nov 2012	BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.	Becton Dickinson & Co.	Device	Class II	1
6 Nov 2012	Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping carton. The cane is used as an aid in walking or ambulation.	Invacare Corporation	Device	Class II	1
6 Nov 2012	Ground limestone also known as calcium carbonate. Omya's food grade ground limestone products. All bulk with no product labeling. Product Container Size Omya-Cal FG-10 AZ 50 lb. bags 2500 lb. bulk bags 2000 lb. bulk bags Omya-Cal FG-4 AZ 50 lb. bags Omya-Cal FG-15 AZ 2500 lb. bulk bags Event 63648	Omya Inc	Food	Class I	1
5 Nov 2012	OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial… Event 63642	OmniGuide, Inc.	Device	Class II	1
5 Nov 2012	Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems…	Varian Medical Systems, Inc. Oncology Systems	Device	Class II	1
5 Nov 2012	Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product Usage: The Arobella Medical AR1000 Wound… Event 63808	Arobella Medical, LLC	Device	Class II	1
5 Nov 2012	The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative…	Beckman Coulter Inc.	Device	Class II	1
5 Nov 2012	MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. The MAYFIELD Base Unit (A3101) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support…	Integra LifeSciences Corporation	Device	Class II	2
5 Nov 2012	traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; NDC 57664-377-18.	Caraco Pharmaceutical Laboratories, Ltd.	Drug	Class II	1
5 Nov 2012	Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54	Boehringer Ingelheim Roxane Inc	Drug	Class II	1
5 Nov 2012	Kroger Deluxe French Vanilla Magnifique Ice Cream, 48 FL OZ laminated carton. INGREDIENTS: MILK, CREAM, SUGAR*CONTAINS: MILK, EGGS DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202*800-632-6900 or www.kroger.com.	Kroger Co	Food	Class I	1
5 Nov 2012	Colby , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed	Name withheld	Food	Class I	4
2 Nov 2012	BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia…	Del Mar Reynolds Medical, Ltd.	Device	Class II	1
2 Nov 2012	Zingerman's Bakehouse Gingerbread Cake Net wt. 3 LB; 1.25 LB	Zingerman's Bakehouse, Inc.	Food	Class II	47
1 Nov 2012	Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.	Roche Diagnostics Operations, Inc.	Device	Class II	1
1 Nov 2012	OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.	Biomet, Inc.	Device	Class II	2
1 Nov 2012	Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.	Biomet, Inc.	Device	Class II	1
1 Nov 2012	Bolthouse Farms Carrot Chips (Croustilles Aux Carottes). No Preservatives. Product of the U.S.A. Net Wt. 16 oz (1 lb) 454 b poids net. UPC 71464 17209 Product was also packed under brand names of Safeway Farms, UPC 21130 70217 and Farm Stand (private label for SuperValue). Bolthouse Farms, Bakersfield, CA Event 63600	Wm Bolthouse Farms Inc	Food	Class I	1
1 Nov 2012	Garden Fresh Gourmet Nacho Cheese Tortilla Chips 14oz bags	Garden Fresh Salsa, Inc.	Food	Class III	3
31 Oct 2012	Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation,…	Cooper Surgical, Inc.	Device	Class II	2
30 Oct 2012	Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics	Philips Healthcare Inc.	Device	Class II	1
30 Oct 2012	Blue Diamond Almond Breeze Almond milk Half Gallon (1.89 L) Paper Carton UPC: 4157005618	HP Hood LLC	Food	Class III	1
26 Oct 2012	Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module…	Hospira Inc.	Device	Class II	3
26 Oct 2012	BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger Event 63646	iwalk inc	Device	Class II	1
25 Oct 2012	The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. The affected GVL and Part numbers are GVL 3 –…	Verathon, Inc.	Device	Class I	1
25 Oct 2012	Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "*BABY QUASARFOR YOUTHFUL RADIANT SKINSkin Rejuvenating System with Sequepulse*Manufactured by: Silver Bay, LLC; Made in the USA, with highest quality components and durable aluminum.…	Quasar Bio-Tech, Inc. dba Silver Bay LLC	Device	Class II	3
25 Oct 2012	Murray's WAFFLE CONE DIP, NET WEIGHT - 7 lb 8 oz (3.40 kg), Product Item Code 835462, Bar code 0 06847 66003 2. The product is packaged in # 10 cans, 3 cans per case.	CSM Bakery Products NA	Food	Class I	1
25 Oct 2012	Frozen Yellowfin Tuna Loin 3/5, 30lbs/case. Event 63785	Red Chamber Company	Food	Class II	1
24 Oct 2012	Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma.…	Sekisui Diagnostics Llc	Device	Class II	1
24 Oct 2012	Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20.	GlaxoSmithKline, LLC.	Drug	Class III	2
24 Oct 2012	Gluten Free Cafe Cinnamon Sesame Bar. The Retail Carton has a UPC 70795-03451 and the Individual Bar has a UPC 70795-03551. The product is labeled in parts: "*Cinnamon Sesame Bars With Flax Seeds & Roasted Peanutsgluten free cafe**NET WT .95 OZ (27g); myglutenfreecafe.com; glutenfreechoices.com	BumbleBar, Inc.	Food	Class I	2
24 Oct 2012	Arnold's Candies Handmade Since 1953 www.arnoldscandies.com Wintergreen Puffs***INGREDIENTS: Sugar, Cream of Tarter, Artificial Flavoring and Coloring WARNING: Manufactured in a facility that also handles peanuts NET WT 6 oz (170g) 0 73629 00308 0 931 High Grove Blvd Akron, OH 44312 Best By: 07/11/14(19)1 lot code…	Dauphin Holdings, Inc. DBA Arnolds Candies	Food	Class II	2
23 Oct 2012	Frozen Tuna Loins 3/5, 30lbs., UPC 8 29838 82310 7. Event 63786	Unified Seafood Company., Inc.	Food	Class II	1
22 Oct 2012	BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part *Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds*	Becton Dickinson & Co.	Device	Class II	1
20 Oct 2012	Iced Broccoli crown, 20lbs. Event 63762	Beachside Produce Llc	Food	Class II	1
19 Oct 2012	Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR Endoskeleton TA VBR is intended for use in the thoracolumbar spine (T1-L5) to…	TITAN SPINE, LLC	Device	Class II	1
18 Oct 2012	NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up…	Philips And Neusoft Medical Systems Co., Ltd.	Device	Class II	1
15 Oct 2012	Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.	Invivo Corporation	Device	Class II	1
12 Oct 2012	Ella's Kitchen yum yummy milk + vanilla baby cookies Net Wt. 3.8 oz (108 g) Ella's Daddy's Company Ella's Kitchen Inc. Montclair, NJ 07042 UPC 845901000526 packaged in a chipboard carton with 12 cookies per box	Ella's Kitchen	Food	Class III	2
11 Oct 2012	The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.	Stryker Medical Division of Stryker Corporation	Device	Class II	1
11 Oct 2012	Longhorn Bar Roasted Peanut with Chocolate (1.23 oz), 144 units per case. The bars are in packaging labeled as Longhorn Bars and have a picture of roasted peanuts and chocolate.	Lin-Mar Partners Inc	Food	Class I	2
10 Oct 2012	Siemens Mobilette Mira, intended use as Mobile x-ray system.	Siemens Medical Solutions USA, Inc	Device	Class II	1
10 Oct 2012	MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light	Siemens Medical Solutions USA, Inc	Device	Class II	1
10 Oct 2012	Ground Hot Pepper Chillies, 5 oz. plastic jars, 24 jars/case; jars labeled in part *Imported and distributed by Nina International Inc., P.O. Box 2176, Hyattsville, MD 20784Product of Ghana** Event 63720	Ernimich, Inc. (dba Nina International, Inc.)	Food	Class I	1
10 Oct 2012	United Dairy Farms brand Oatmeal Cookie Overload Ice Cream 3 gallon, corrugated square Event 63749	United Dairy Farmers Inc	Food	Class I	1
10 Oct 2012	Nestle Coffee-Mate Coffee Creamer, Original Flavor, packaged as 3/8 fl oz single serve tubs.50 single serve tubs are packaged in a self dispensing fiberboard box. Four fiberboard boxes are packaged in a case. Event 63498	Name withheld	Food	Class II	1
8 Oct 2012	Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of diseases such as iron deficiency anemia and…	Siemens Healthcare Diagnostics, Inc.	Device	Class II	1
8 Oct 2012	Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06	GlaxoSmithKline, LLC.	Drug	Class II	1
5 Oct 2012	Vitanut Pro IC, 50 g Event 63421	Breedlove Foods, Inc.	Food	Class I	1
4 Oct 2012	Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02.	Hospira, Inc.	Drug	Class II	1
3 Oct 2012	STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad…	Advanced Sterilization Products	Device	Class II	1
3 Oct 2012	"Sazon con Culantro y Achiote" (seasoning)	Gasco Industrial	Food	Class II	1
3 Oct 2012	"beer set dried rudd", NET WT 200 g (7 oz), PRODUCT OF RUSSIA, BEST BEFORE 10.22.2012 --- The product was packaged in a vacuum packed bag. According to the Food Lab Report, the sample consisted of two (2) whole fish measuring 8 inches and 10 inches in length. Event 63382	KRASNYI OKTYABR INC	Food	Class I	1
2 Oct 2012	Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.	Becton Dickinson & Company	Device	Class II	1
1 Oct 2012	Cold-Smoked Atlantic Salmon in vacuum packed plastic, labeled in part: "FOPPEN NORWEGIAN SMOKED SALMON SLICES INCLUDES PACKET OF HONEY MUSTARD DILL SAUCE READY TO EAT PEPPERED TRADITIONAL DILL NET WT 12oz / 341g (291g Salmon + 50g Sauce 8 712224 129277***INGREDIENTS SALMON: Atlantic Salmon (Salmo salar), salt,… Event 63546	Costco Wholesale	Food	Class II	1
29 Sep 2012	Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178	Ebi, Llc	Device	Class II	1
28 Sep 2012	Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for…	Varian Medical Systems, Inc.	Device	Class II	1
27 Sep 2012	CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed by: Genentech USA, Inc., South San Francisco, CA 94080.	Genentech, Inc.	Drug	Class III	1
24 Sep 2012	Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series…	Mindray DS USA, Inc. d.b.a. Mindray North America	Device	Class II	1
21 Sep 2012	NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; collagen…	Zimmer, Inc.	Device	Class II	1
20 Sep 2012	Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure.	Medline Industries Inc	Device	Class II	1
20 Sep 2012	Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01	Genentech Inc	Drug	Class II	2
31 Aug 2012	Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.	Bausch & Lomb Inc	Device	Class II	1
27 Aug 2012	Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish) Event 63017	Samantha Lynn, Inc	Drug	Class I	1
24 Aug 2012	The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only, do not resterilize, and is available only by…	Iradimed Corporation	Device	Class II	1
23 Aug 2012	Novarel (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0 Manufactured for : Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 Manufactured by: DRAXIS Specialty Pharmaceuticals Inc., Quebec, Canada. NDC # 55566-1501-0 is assigned to the vial of NOVAREL and…	Ferring Pharmaceuticals Inc	Drug	Class III	1
14 Aug 2012	Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543, by Hollister-Stier Laboratories LLC, Spokane Washington 99207, NDC 0270-0083-20.	Bracco Diagnostic Inc	Drug	Class III	1
8 Aug 2012	Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include 2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, 1059-C, *1058-C, 4000… Event 63235	Parks Medical Electronics, Inc	Device	Class II	1
6 Aug 2012	The Is-anti-Sm test kits**Catalog No: 720-240* Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml…	Diamedix Corporation	Device	Class II	1
6 Aug 2012	ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobility impaired person in a fold-down seat up and down straight stairs, indoors and outdoors. Event 62826	ThyssenKrupp Access Corp	Device	Class II	1
1 Aug 2012	GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace…	GE Healthcare, LLC	Device	Class II	3
28 Jul 2012	Tumulo Farms, Pondhopper Cheese; any cut or partial wheels, wrapped in cheese paper with with type of cheese marked with magic marker and a Tomales Bay Foods sticker applied. Product is cut and packaged by Tomales Bay Foods, Petaluma, CA	Tomales Bay Foods, Inc.	Food	Class I	3
27 Jul 2012	Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France The Offset Bushings are parts…	Stryker Howmedica Osteonics Corp.	Device	Class II	2
16 Jul 2012	Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS AmpliPrep instrument, COBAS TaqMan analyzer, COBAS TaqMan 48 analyzer, COBAS AMPLICOR analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain…	Roche Molecular Systems, Inc.	Device	Class II	10
9 Jul 2012	Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.	Lloyd Inc. of Iowa	Drug	Class II	12
29 Jun 2012	Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01 Event 62454	Mylan LLC.	Drug	Class II	1
26 Jun 2012	GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor…	GE Healthcare, LLC	Device	Class II	1
20 Jun 2012	Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System	Siemens Medical Solutions USA, Inc	Device	Class II	1
8 Jun 2012	Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.	Merit Medical Systems, Inc.	Device	Class II	1
29 May 2012	Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed: " VesselIQ Xpress or AVA Xpress " CardIQ Xpress Pro or Plus " CardEP " CardIQ Fusion PET or SPECT Advantage Workstations Volume Share…	GE Healthcare, LLC	Device	Class II	1
9 May 2012	The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored…	Natus Medical Incorporated	Device	Class I	1
18 Apr 2012	Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.	Medrad Inc	Device	Class II	11
17 Feb 2012	GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.	GE Healthcare, LLC	Device	Class II	1
9 Feb 2012	Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.	Covidien LLC dba Uni-Patch	Device	Class II	4
13 Oct 2011	Mercer's Ice Cream Old Fashioned Cookie Dough, Half Gallon, (1.89 Liter), UPC 036667 200231	Quality Dairy Farms Inc.	Food	Class II	3
20 Sep 2011	Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.	Metrex Research, LLC.	Device	Class II	1
9 Jul 2011	Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and… Event 60030	First Medical Source LLC	Device	Class I	1
24 May 2011	Neptune 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid waste, small debris and electrocautery smoke…	Stryker Instruments Div. of Stryker Corporation	Device	Class II	2
25 Apr 2011	IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.	Extremity Medical LLC	Device	Class II	1
8 Apr 2011	Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6164-1.	Physicians Total Care, Inc.	Drug	Class III	3
4 Nov 2010	Baugher's Apple Cider, one gallon and half gallon plastic jugs, with plastic caps labeled in part *Fresh* Preservatives added-keep under refrigeration*. Jugs are labeled in part *FDA Required Warning: This product has not been pasteurized and therefore may contain harmful bacteria that can cause serious… Event 57212	Baugher Enterprises, Incorporated	Food	Class I	1
4 Oct 2010	Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen Inc., Thousand Oaks, CA 91320; Dist. By: Physicians Total Care, Tulsa, OK 74146; NDC 54868-5673-1.	Physicians Total Care, Inc.	Drug	Class II	1
16 Sep 2010	Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.	Kimberly-Clark Corporation	Device	Class II	1
11 Aug 2010	DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST…	Mindray DS USA, Inc. d.b.a. Mindray North America	Device	Class II	1

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Sources

NHTSA recall file through: 29 Sep 2026
Newest CPSC recall on the register: 24 Sep 2026
openFDA export date: 28 Sep 2026

How the register is made. Data sources and licences.

Questions

Which NHTSA campaign of December 2012 has the most units?: Campaign 12V573000, with 807,161 units. NHTSA received the report on 11 Dec 2012.
Which CPSC recall of December 2012 has the most units?: CPSC recall 13073, with about 457,000 units. The CPSC title is: LG Recalls Top-Loading Washing Machines Due to Risk of Injury
How many FDA recalls of December 2012 are in Class I?: 33 of the 141 FDA enforcement events with a report date in December 2012.
Which date puts a recall in December 2012?: For NHTSA, the date NHTSA received the report. For CPSC, the recall date. For FDA, the first report date of the event.