Recall Register

Recalls in October 2021

NHTSA received 78 vehicle recall campaigns in October 2021. NHTSA also received 6 child seat, tire or equipment campaigns. The NHTSA campaigns have 612,226 units in total. 13 CPSC recalls have a recall date in the month, with about 212,610 units. FDA enforcement reports of the month have 154 events.

All months

Counts

NHTSA vehicle campaigns
78September 2021: 87
NHTSA child seat, tire and equipment campaigns
6
Units in the NHTSA campaigns
612,226
CPSC product recalls
13September 2021: 17
FDA enforcement events
154September 2021: 172

Download all recalls of October 2021 (CSV)

NHTSA

Vehicles, child seats, tires and equipment.

NHTSA recall campaigns that NHTSA received in October 2021, newest first
ReceivedCampaignFirst vehicle or productComponentTypeManufacturerUnits
29 Oct 202121E092000Axalta Coating Systems ClearcoatVisibilityEquipmentAxalta Coating Systems100,275
29 Oct 202121V843000Mercedes-Benz S 580 2021Engine and Engine CoolingVehicleMercedes-Benz USA, LLC8,669
29 Oct 202121V844000Kia Optima Hybrid 2017 and 3 moreEngineVehicleKia Motors America10,731
29 Oct 202121V845000Thor Motor Coach Outlaw 2017 and 2 moreStructureVehicleThor Motor Coach424
29 Oct 202121V846000Tesla Model 3 2017 and 16 moreForward Collision AvoidanceVehicleTesla, Inc.11,728
28 Oct 202121E091000American Chrome Mack Hubcap KIT and 1 moreWheelsEquipmentAmerican Chrome Company1,357
28 Oct 202121V842000Dodge Durango 2021StructureVehicleChrysler (FCA US, LLC)4,837
27 Oct 202121V840000Hyundai Palisade 2021Service Brakes, HydraulicVehicleHyundai Motor America995
27 Oct 202121V841000Great Dane Freedom 2021 and 8 moreService Brakes, HydraulicVehicleGreat Dane Trailers1,843
27 Oct 202121V847000Palfinger Material Handling Cranes 2018 and 6 moreEquipmentVehiclePalfinger USA, LLC316
26 Oct 202121E090000Wabco Trailer Iabs-2MService Brakes, AirEquipmentWABCO USA LLC277
26 Oct 202121V839000Nissan Rogue 2017 and 2 moreHybrid Propulsion SystemVehicleNissan North America, Inc.5,905
25 Oct 202121V834000Tesla Model 3 2023 and 2 moreAir BagsVehicleTesla, Inc.3
25 Oct 202121V835000Tesla Model 3 2019 and 4 moreSuspensionVehicleTesla, Inc.2,791
25 Oct 202121V836000Yamaha Tracer 9 GT 2021EquipmentVehicleYamaha Motor Corporation, USA16
25 Oct 202121V837000IC Bus Cesb 2021 and 3 moreEngine and Engine CoolingVehicleNavistar, Inc.7,322
25 Oct 202121V838000IC Bus CE 2021 and 1 moreEngine and Engine CoolingVehicleNavistar, Inc.5
23 Oct 202121V833000Ferrari 488 GTB 2016 and 20 moreService Brakes, HydraulicVehicleFerrari North America, Inc.9,985
22 Oct 202121V828000Coachmen Catalina 2022EquipmentVehicleForest River, Inc.101
22 Oct 202121V829000Forest River XLR Toyhauler 2022EquipmentVehicleForest River, Inc.3
22 Oct 202121V830000Forest River XLR Toyhauler 2021 and 1 moreStructureVehicleForest River, Inc.125
22 Oct 202121V831000BMW X4 2022Exterior LightingVehicleBMW of North America, LLC2,577
22 Oct 202121V832000Mercedes-Benz GLE 580 2021 and 6 moreVisibilityVehicleMercedes-Benz USA, LLC23
21 Oct 202121V827000Orange EV T-Series Electric Truck 2019 and 2 moreSteeringVehicleOrange EV252
20 Oct 202121V824000Sutphen Fire Truck 2020EquipmentVehicleSutphen Corporation1
20 Oct 202121V825000Audi A3 2022 and 15 moreBack Over PreventionVehicleVolkswagen Group of America, Inc.2,857
20 Oct 202121V826000Doosan Portable Power Mobile Generator 2021 and 5 moreDo-not-drive advisoryWheelsVehicleDoosan Portable Power580
19 Oct 202121V822000Newmar Essex 2020 and 7 moreSteeringVehicleNewmar Corporation38
19 Oct 202121V823000Sutphen Fire Truck 2020 and 1 moreExterior LightingVehicleSutphen Corporation2
18 Oct 202121V815000Ferrara Pumper 2021EquipmentVehicleFerrara Fire Apparatus, Inc.1
18 Oct 202121V816000Schwarze M6 Avalanche Street Sweep 2017 and 17 moreEquipmentVehicleSchwarze Industries, Inc.547
18 Oct 202121V817000Chevrolet Traverse 2020 and 1 morePower TrainVehicleBraun Corporation639
18 Oct 202121V818000Mercedes-Benz GLS 580 4MATIC 2020 and 5 moreSeatsVehicleMercedes-Benz USA, LLC27
18 Oct 202121V819000Kawasaki W800 2021 and 1 moreEngine and Engine CoolingVehicleKawasaki Motors Corp., U.S.A.574
18 Oct 202121V820000Triple E Libero 2016 and 13 moreEquipmentVehicleTriple E Recreational Vehicles2,056
18 Oct 202121V821000Mitsubishi Outlander 2022StructureVehicleMitsubishi Motors North America, Inc.1
15 Oct 202121V805000Ford F-150 2021 and 4 moreAir BagsVehicleFord Motor Company777
15 Oct 202121V806000Yamaha XVS950 2021 and 1 moreDo-not-drive advisoryEngineVehicleYamaha Motor Corporation, USA233
15 Oct 202121V807000HME Ram 5500 2018 and 2 moreWheelsVehicleHME, Inc.5
15 Oct 202121V808000HME Ram 5500 2019Engine and Engine CoolingVehicleHME, Inc.3
15 Oct 202121V809000Ford Bronco Sport 2021VisibilityVehicleFord Motor Company1,036
15 Oct 202121V810000Smeal Pumper 2021EquipmentVehicleSmeal Holding, LLC1
15 Oct 202121V811000Ford Ranger 2020 and 2 moreSeat BeltsVehicleFord Motor Company47,683
15 Oct 202121V812000Volkswagen Atlas Cross Sport 2021 and 2 moreSuspensionVehicleVolkswagen Group of America, Inc.30
15 Oct 202121V813000Trail King Aacs 2019 and 11 moreSuspensionVehicleTrail King Industries, Inc.209
15 Oct 202121V814000KZRV Stratus 2022 and 1 moreElectrical SystemVehicleKZRV, L.P.8
14 Oct 202121E089000Chevrolet All-Weather Floor LinerEquipmentEquipmentGeneral Motors, LLC3,889
14 Oct 202121V797000Jeep Grand Cherokee 2021Exterior LightingVehicleChrysler (FCA US, LLC)7,082
14 Oct 202121V798000Ram 2500 2022 and 7 morePark-outside advisoryElectrical SystemVehicleChrysler (FCA US, LLC)131,177
14 Oct 202121V799000Van Hool T2145 2003 and 31 moreEquipment Adaptive/MobilityVehicleVan Hool N.V.422
14 Oct 202121V800000Volvo V70 2003 and 13 moreAir BagsVehicleVolvo Car USA, LLC194,546
14 Oct 202121V801000Heartland Mallard Pathfinder 2022 and 1 moreEquipmentVehicleHeartland Recreational Vehicles, LLC332
14 Oct 202121V802000Cruiser RV Hitch 2021 and 1 moreEquipmentVehicleCruiser RV264
14 Oct 202121V803000Tiger Bengal TX 2019 and 1 moreEquipmentVehiclePROVAN INDUSTRIES, LLC13
14 Oct 202121V804000Honda CT125 2021Power TrainVehicleHonda (American Honda Motor Co.)2,181
13 Oct 202121V794000Porsche Taycan 2020 and 1 moreExterior LightingVehiclePorsche Cars North America, Inc.11,827
13 Oct 202121V795000Zero SR/F 2020Service Brakes, HydraulicVehicleZero Motorcycles Inc.411
13 Oct 202121V796000Genesis GV70 2022 and 4 moreSeat BeltsVehicleHyundai Motor America978
12 Oct 202121E088000Arcimoto Trio Conversion KITEquipmentEquipmentTilting Motor Works310
12 Oct 202121V791000HME Ford F-550 2014 and 3 moreElectrical SystemVehicleHME, Inc.8
12 Oct 202121V792000KTM 690 Enduro R 2020 and 18 morePower TrainVehicleKTM North America, Inc.8,398
12 Oct 202121V793000Winnebago Travato 2020 and 5 moreElectrical SystemVehicleWinnebago Industries, Inc.267
11 Oct 202121V789000Mercedes-Benz S 500 2021 and 1 moreAir BagsVehicleMercedes-Benz USA, LLC1,311
11 Oct 202121V790000HME 1871 2018 and 39 moreFuel System, DieselVehicleHME, Inc.245
9 Oct 202121V788000Foretravel Realm 2021 and 8 moreEquipmentVehicleForetravel, Inc.71
8 Oct 202121V784000Forest River Puma 2022 and 1 moreEquipmentVehicleForest River, Inc.44
8 Oct 202121V785000East TO West Entrada 2022 and 1 moreService Brakes, HydraulicVehicleForest River, Inc.19
8 Oct 202121V786000Startrans School Bus 2015 and 2 moreEquipmentVehicleForest River, Inc.468
8 Oct 202121V787000Starcraft Bus Transit Bus 2015 and 4 moreEquipmentVehicleForest River, Inc.7,593
7 Oct 202121V782000Buick Enclave 2008 and 14 moreAir BagsVehicleGeneral Motors, LLC555
7 Oct 202121V783000Tiffin Phaeton 2021 and 1 moreElectrical SystemVehicleTiffin Motorhomes, Inc.111
6 Oct 202121V777000Aluma Aluma 2021StructureVehicleAluma KLM160
6 Oct 202121V778000Blue Bird Vision School Bus 2022Service Brakes, HydraulicVehicleBlue Bird Body Company135
6 Oct 202121V779000Mercedes-Benz Sprinter 1500 2021 and 3 moreElectrical SystemVehicleDaimler Vans USA, LLC38
6 Oct 202121V780000Nexus Evoque 2019 and 26 moreEquipmentVehicleNexus RVs, LLC2,000
6 Oct 202121V781000Volvo VNL 2022Power TrainVehicleVolvo Trucks North America162
5 Oct 202121V776000Spartan K2 2021 and 5 moreSuspensionVehicleShyft Group660
4 Oct 202121V774000Nissan Pathfinder Hybrid 2014 and 7 moreEngine and Engine CoolingVehicleNissan North America, Inc.7,634
4 Oct 202121V775000Peach Cargo Cargo Trailer 2022 and 1 moreSuspensionVehiclePeach Cargo LLC457
1 Oct 202121E087000Arcimoto Trio Conversion KITEquipmentEquipmentArcimoto Inc30
1 Oct 202121V770000Ford Bronco 2021Air BagsVehicleFord Motor Company553
1 Oct 202121V771000Mercedes-Benz GLS 580 4MATIC 2020Air BagsVehicleMercedes-Benz USA, LLC3
1 Oct 202121V772000Micro Bird G5 Transit Bus 2022WheelsVehicleCorp. Micro Bird, Inc.1
1 Oct 202121V773000Micro Bird G5 School Bus 2022WheelsVehicleCorp. Micro Bird, Inc.3

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 October 2021
DateRecallFirmCategoryHazardUnitsCPSC number
28 Oct 2021Design Within Reach Recalls Arc Collection Furniture Due to Violation of the Federal Lead Paint Ban (Recall Alert)Design Within ReachLead or chemical, Poisoning, Violation of standard20022704
27 Oct 2021Meridian Furniture Recalls Ottomans Due to Laceration HazardMeridian FurnitureLaceration7,80022012
27 Oct 2021Magnussen Home Recalls Nova Series 5-Drawer Chests Due to Tip-Over and Entrapment HazardsMagnussen Home FurnishingsEntrapment, Tip-over13,20022011
27 Oct 2021Liberty Hardware Recalls Glass Cabinet Knobs Due to Laceration HazardLiberty Hardware MfgLaceration38,00022010
27 Oct 2021myCharge Recalls Powerbanks Due to Fire and Burn HazardsRFA Brands LLC, d/b/a myChargeFire, Burn, Overheating67,00022009
27 Oct 20215.11 Recalls Tactec Plate Carriers Due to Injury Hazard5.1145,17022008
22 Oct 2021Walmart Recalls Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones Due to Rare and Dangerous Bacteria; Two Deaths InvestigatedWalmartMould or bacteria3,90022007
21 Oct 2021Lightform Recalls LED Projectors Due to Fire Hazard (Recall Alert)LightformFire, Overheating1,60022703
21 Oct 2021KTM North America Recalls Off-Road Motorcycles Due to Crash Hazard (Recall Alert)KTM North AmericaFall, Crash1,84022702
13 Oct 2021Specialized Bicycle Components Recalls Tarmac SL7 Bicycles and Framesets Due to Fall and Injury HazardsSpecialized Bicycle ComponentsFall, Impact injury6,90022006
7 Oct 2021Joovy Recalls Zoom 360 Ultralight Jogging Strollers Due to Fall Hazard (Recall Alert)Joovy HoldingFall9,20022701
6 Oct 2021Hobby Lobby Recalls White Wood Stools Due to Fall and Injury HazardsHobby Lobby StoresFall14,00022004
6 Oct 2021ElliptiGO Recalls Arc Model Stand-Up Bicycles Due to Fall and Injury HazardsElliptiGOFall3,80022003

FDA

Food, drugs and devices.

94 device, 34 food, 26 drug. 122 Class II, 27 Class I, 5 Class III.

FDA enforcement events with a report date in October 2021
InitiatedProduct (first record)Recalling firmTypeClassRecords
8 Oct 2021Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68180-316-06Lupin Pharmaceuticals Inc.DrugClass II1
8 Oct 2021Parent's Choice Rice Baby Cereal. Stage 1, 4+ months. Fully Cooked. Just add Liquid. Net Wt 8 oz (227g) UPC 81131-08290. Distributed By: Walmart Inc., Bentonville, AR 72716. Event 88827Maple Island Inc .FoodClass II1
7 Oct 2021Ingredion INSTANT PURE-FLOW F Food Starch, 50lb bag, material 12151103CAIngredion IncorporatedFoodClass II1
7 Oct 2021Whataburger Picante Sauce NET WT 0.6 oz (17g) packaged in high impact polystyrene cups; 400 cups per case Event 88851Golden State Foods Corp.FoodClass II1
6 Oct 2021SunGarden Mung Bean Sprouts 5lb & 10lb packaged in clear plastic bag in white cardboard boxInternational Sprout Holding Inc.FoodClass I1
5 Oct 2021Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1 Event 88809Name withheldDrugClass II1
5 Oct 2021Chocolate & the Chip The Original Cookies: 4 oz / 114 grams per pack. Cookies are packaged in uniform pairs in a food grade clear resealable bag and label Corrected Ingredients: Original chocolate chip cookie: Ingredients: All purpose flour (bleached wheat flour, malted barley flour, niacin, reduced iron, ascorbic…Chocolate and the ChipFoodClass II26
4 Oct 2021Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11Akorn, Inc.DrugClass II1
1 Oct 2021REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852Name withheldDeviceClass II2
1 Oct 2021Driscolls's Fresh Blueberries 6 oz. and 1 pt. clamshell containers Keep refrigerated and rinse before use.Driscoll's Inc.FoodClass II1
30 Sep 2021Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0Beiersdorf IncDrugClass I8
30 Sep 2021Lake Wolf Creamery Queso Fresco, crumbling fresh cheese, refrigerated, vacuum packaged in flexible plastic packages, net wt. 1.5 lbs. or 0.5 lbs. No UPC.Lake Wolf CreameryFoodClass II3
29 Sep 2021Tone s Taco Seasoning Blend, Plastic Bottles / 12 bottles per case with best by dates of SEPT 03 24 and SEPT 06 24, due to theB&G Foods North America, IncFoodClass I1
28 Sep 2021Atellica IM 1300 Analyzer, SMN 11066001Siemens Healthcare Diagnostics, IncDeviceClass II2
28 Sep 2021Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093. Event 88771ELEKTA SOLUTIONS ABDeviceClass II1
27 Sep 2021Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.Strides Pharma Inc.DrugClass II1
27 Sep 2021Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x4 pack containing 4 Single-dose vials artesunate (73607-001-01) and 4 vials sterile diluent (NDC 73607-001-02) per… Event 88772AMIVAS (US), LLCDrugClass II1
24 Sep 2021Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01Eli Lilly & CompanyDrugClass I1
24 Sep 2021FAIRLIFE MILK 8OZ / 6PK CHOCOLATE (multi-pack format of small single serve bottle); Date Code "MAY2722 FA"; Case UPC 008-11620-02207-1; Unit UPC 008-11620-02206-4 Event 88782Fairlife LlcFoodClass II1
24 Sep 2021Vemondo Vegan Crabless Mini Crabcakes by Lidl 8.5 OUNCES (240g) coated paper box ten (10) packages per case. Frozen. Event 88781Cuisine Innovations Unlimited, LLCFoodClass I1
24 Sep 2021Roasted Lightly Salted Cashew Halves and Pieces, 8 oz. , UPC 072036734884. 8 bags/case.Suntree Snack Foods, LLCFoodClass II11
23 Sep 2021SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051DiaSorin Molecular LLCDeviceClass II1
23 Sep 2021Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01Monarch PCM, LLCDrugClass II1
22 Sep 2021AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08Teva Pharmaceuticals USADrugClass II5
22 Sep 2021Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213New Vitalis Pharmacy LLC dba New Vitalis PharmacyDrugClass II1
22 Sep 2021Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. NDC 60652-6429-1SSM Health Care St. Louis DBA SSM St. Clare Health CenterDrugClass II1
22 Sep 2021Brownie Chocolate Walnuts, Carton with 96 retail units, A210107B Event 88752Kelly's Bakery Corp.FoodClass II1
22 Sep 2021Whole Foods Market Everyday Double Crust Cherry Pie sold in clear plastic clamshell with scale label applied. Sold as whole pie or by the slice. PLUs 74874, 74401, 33405Whole Foods Market Brand 365, LlcFoodClass I2
21 Sep 2021Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52,…Datascope Corp.DeviceClass I1
21 Sep 2021EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232Philips Ultrasound IncDeviceClass II1
21 Sep 2021Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14SigmaPharm Laboratories LLCDrugClass II1
21 Sep 2021Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3 Event 88754Sanitor CorporationDrugClass II1
21 Sep 2021Dairy Free Co. Dollup Lama Sour & Creamy Cashew Topping 4oz, 6 containers per case Event 88756Central Kitchen Food HubFoodClass III1
20 Sep 20216.5MMX165MM CANNULATED SCREWSmith & Nephew, Inc.DeviceClass II1
20 Sep 2021Litehouse item 15533 Ranch dressing packaged in 1.25 oz. plastic cup with seal, 336 cups per case. It is printed on the side of a plastic cup as 1231 1.25 OZ 02 83027 15533 RANCH. These cups are un-labeled and not intended for sale as individual cup at retail stores. The master case label is read in parts: "***RANCH…Litehouse IncFoodClass I1
20 Sep 2021Mr. Nut brand Dried Oleaster Net Wt: 10.6 OZ (300g). Expiration date 10/2022. UPC 0360894900.Vintage Food Corp.FoodClass III1
17 Sep 2021Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Synergy; d. Elekta Infinity; e. Versa HDElekta, Inc.DeviceClass II1
17 Sep 2021Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipperFresenius Kabi USA LLCDrugClass II1
17 Sep 2021ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1IntegraDose Compounding Services LLCDrugClass II2
17 Sep 2021GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11)American Health PackagingDrugClass II1
17 Sep 2021Kalona Supernatural Organic Whipping Cream, Manufactured in Iowa for Kalona Organics, LLC. Kalona IA in 16 FL OZ (UPC 8-81245-12016-2, 8 bottles per case) and 32 FL OZ (UPC 8-81245-12032-2, 6 bottles per case)Farmers' All Natural Creamery LLCFoodClass II3
16 Sep 2021Green Field Farms Chocolate Milk 1/2 gallon glass jar, 6 units per case 53oz plastic bottle, 6 units per case 12oz plastic bottle, 8 units per case Event 88729Green Field Farms Co-opFoodClass II1
16 Sep 2021Earle of Sandwiches Mild Smoked Jalapeno Sub, Smoked Jalapeno Sausage and Peperjack Cheese on Parmasan Crusted French Bread. Net Wt. 7oz (198g), UPC 97256 75671, Keep Refrigerated. Earle of Sandwiches, Willernie, MN 55090The Earl of SandwichesFoodClass I5
15 Sep 2021Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42American Health PackagingDrugClass II1
15 Sep 2021Driscoll's Only the Finest Berries - Blueberries/ Bluets 6 oz. and 1 pt. plastic clamshell containers. Product of PeruDriscoll's Inc.FoodClass II1
15 Sep 2021KALE NET WT 16 OZ (1 LB) 454g Sold under the following brand names: Baker Farms 3667 Ellenton Norman Park Road, Norman Park GA 31771 UPC 8 13098 02001 6; Kroger DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 18170 1 & SEG Grocers DISTRIBUTED BY: SOUTHEASTERN GROCERS 8928 PROMINENCE PKWY #200,… Event 88689Terry and Joe Baker Farms, Llc dba Baker FarmsFoodClass I1
14 Sep 2021Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.Elekta IncDeviceClass II1
14 Sep 2021HEB Jumbo Stuffed Shells; Jumbo Shells Filled with Creamy Ricotta and Romano Cheese; NET WT. 22 OZ (1 LB 6OZ) 624g Event 88672SEVIROLI FOODSVERTULLO IMPORTSFoodClass II1
14 Sep 2021Crunchy Cones, Chocolate, 12, NET WT 40oz (113g)Borinquen Cones of Puerto Rico, Inc.FoodClass III2
13 Sep 2021ARCH Leg Positioning System Event 88636Innovative Orthopedic Technologies, LLCDeviceClass II1
13 Sep 2021Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.Medtronic Perfusion SystemsDeviceClass II1
13 Sep 2021Buurma Farms Plain Parsley (Flat Parsley) PLU twist tie or banded bunches 30ct in cardboard cartons 60ct in wooden crates Event 88678Buurma Farms IncFoodClass II1
13 Sep 2021Enrico Biscotti - Cranberry Pistachio Biscotti 8 ounce bags 6 bags per caseThe Enrico Biscotti CompanyFoodClass II2
13 Sep 2021Rc Cola 12 Oz (355 mL) packaged in an aluminum can 12 can to a pack Event 88723Name withheldFoodClass II1
10 Sep 2021Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths) Event 88760Kinsman Enterprises IncDeviceClass II1
10 Sep 2021Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400Draeger Medical, Inc.DeviceClass II2
10 Sep 2021VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack…Ortho Clinical Diagnostics IncDeviceClass II1
10 Sep 2021FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.) Event 88700Name withheldDeviceClass II1
10 Sep 2021Tenaculum, PlasticStradis Medical, LLC dba Stradis HealthcareDeviceClass II6
10 Sep 2021Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41Piramal Critical Care, Inc.DrugClass II1
10 Sep 2021Little Debbie Mini Nutty Buddy Cookie Bites Sandwich Cookies 2.5oz plastic packaging 72 pouches per case Event 88668Mckee Foods CorporationFoodClass II1
9 Sep 2021GENOSYL DS (Delivery System) console, for use as a vasodilator.Vero Biotech, LLCDeviceClass I1
9 Sep 2021ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001DePuy Orthopaedics, Inc.DeviceClass II1
9 Sep 2021Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01. Event 88647Jacobus Pharmaceutical Company Inc.DrugClass I1
9 Sep 2021Vanilla Flavor Imitation (White), Net Contents 128 FL. OZS. (1 Gallon)Medina Baking and Powder Products, Inc.FoodClass I2
9 Sep 2021Bunches of curly parsley packed in cardboard cases received at distributor level with following labeling: Herb Parsley Curly Grown in Salinas 60EA x 60EA Bunch US or 30EA x 60EA Bunch US Dole Fresh Vegetables, Monterey, CA 93940 PLU 4899 0 07143 00310 Harvest Date Aug18 Bunches of curly parsley displayed on produce…Dole Fresh Vegetables IncFoodClass II1
9 Sep 2021Brain MD - Brain & Memory Power Boost Supports Healthy Brain and Memory Performance 120 capsules - Dietary Supplement UPC: 8 57568 00341 3 Serving Size - 4 capsules' Servings per container - 30 Ingredients - amount per serving: Phosphatidylserine (PS) - 100 mg Acetylcarnitine - 666 mg N-Acetylcysteine (NAC) - 400 mg… Event 88739BRAINMDFoodClass II1
8 Sep 2021Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068K2M, IncDeviceClass II1
8 Sep 2021Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65Datascope Corp.DeviceClass II2
8 Sep 2021Kit: Central Line Dres Change 20/CsMedical Action Industries, Inc. 306DeviceClass II1
8 Sep 2021Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65Datascope Corp.DeviceClass II2
7 Sep 2021Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:W L Gore & Associates, Inc.DeviceClass II1
7 Sep 2021Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep. Event 88673NOX MEDICALDeviceClass II1
7 Sep 2021GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD,…DJO, LLCDeviceClass I2
7 Sep 2021De Wafelbakkers 18 ct Buttermilk Pancakes NET WT 1 lb. 8.7 oz. (703g) KEEP FROZEN packaged in clear flexible plastic UPC 679844104573 Event 88646De Wafelbakkers, LLCFoodClass II1
6 Sep 2021Velvet Ice Cream Raspberry Fudge Cordial 1.75 quarts (56oz) 6 quarts per caseVelvet Ice Cream CompanyFoodClass I1
3 Sep 2021cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190Roche Molecular Systems, Inc.DeviceClass II1
3 Sep 2021ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD,…Welch Allyn Inc MortaraDeviceClass II1
3 Sep 2021Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201Flower Orthopedics CorporationDeviceClass II1
2 Sep 2021MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO SystemBioMerieux SADeviceClass II1
2 Sep 2021DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming SetDeroyal Industries, Inc. LafolletteDeviceClass I1
2 Sep 2021Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mmMedtronic Sofamor Danek USA IncDeviceClass II2
2 Sep 2021MOSAIQ Oncology Information SystemElekta, Inc.DeviceClass II1
2 Sep 2021Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnosticAbbott Molecular, Inc.DeviceClass I5
2 Sep 2021Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057 9 Distributed by: CVS Pharmacy, Inc.…New Vision Pharmaceuticals LLCDrugClass III2
2 Sep 2021Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01RISING PHARMACEUTICALSDrugClass II1
2 Sep 2021Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz. White Round PET 24/410 bottleMonarch PCM, LLCFoodClass II1
1 Sep 2021Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721Flower Orthopedics CorporationDeviceClass II4
31 Aug 2021Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x…Medtronic Xomed, Inc.DeviceClass II3
31 Aug 2021Thoraguard Chest Tube Kit, 20 Fr Event 88616Centese Inc.DeviceClass II1
30 Aug 2021OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX,…Exactech, Inc.DeviceClass II9
27 Aug 2021United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025 Event 88692Uoc Usa IncDeviceClass II1
27 Aug 2021Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North Coast Ultrasound Gel, 5 liters (4);…North Coast Medical IncDeviceClass I2
26 Aug 2021SIGNA Premier nuclear magnetic resonance imaging systemGE Healthcare, LLCDeviceClass II10
26 Aug 2021Atrium Pneumostat Chest Drain Valve, Part Number 16100Atrium Medical CorporationDeviceClass II1
25 Aug 2021HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP Family, ACL TOP Family 50 Seriest and ACL Elite/Elite Pro/8/9/10000) Part Number:…Instrumentation LaboratoryDeviceClass II3
25 Aug 2021Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.Atrium Medical CorporationDeviceClass II1
25 Aug 2021Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures. Event 88602Accelerated Care Plus CorporationDeviceClass I1
25 Aug 2021Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.Deerfield Imaging, Inc.DeviceClass II3
24 Aug 2021Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion. Original Jamshidi" Bone Marrow…Bard Peripheral Vascular IncDeviceClass II2
24 Aug 2021ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound…National Distribution & Contracting IncDeviceClass I2
24 Aug 2021Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals,…Azurity Pharmaceuticals, Inc.DrugClass I1
23 Aug 2021Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue. Event 88624Aesthetics Systems Usa IncDeviceClass I1
23 Aug 2021Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01 Event 88542ViatrisDrugClass II1
20 Aug 2021DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)ConvaTec, IncDeviceClass II1
20 Aug 2021Aconitum nap Fear* 87% Alcohol HPUS: 5X, 7X, 18X, 30X, packaged in 30 mL containers, Aconitum nap Fear* 87% Alcohol HPUS: 24X, packaged in 50 mL containers, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.Washington Homeopathic Products, Inc.DrugClass II39
19 Aug 2021Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,Philips Ultrasound IncDeviceClass II2
19 Aug 2021P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641Fort Defiance Industries, LLCDeviceClass II1
16 Aug 2021Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.Biodex Medical Systems, Inc.DeviceClass II2
16 Aug 2021BF-N20 OES Bronchofiberscope, Model No. BF-N20Olympus Corporation of the AmericasDeviceClass II10
13 Aug 2021Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures. Event 88611IMPERATIVE CARE INCDeviceClass I1
13 Aug 2021VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridgedGreiner Bio-One North America, Inc.DeviceClass II1
12 Aug 2021Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing systemGE Healthcare, LLCDeviceClass II1
11 Aug 2021OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056Hill-Rom, Inc.DeviceClass II5
11 Aug 2021EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMURed Medical SuppliesDeviceClass I3
10 Aug 202115 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212B. Braun Medical, Inc.DeviceClass II17
9 Aug 2021Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACKBeckman Coulter Inc.DeviceClass II1
6 Aug 2021NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (2) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038303, UPN H965640383031, 3 Valve Manifold, On Star Handles, Ports on Right, Rx only,…Medline Industries IncDeviceClass II2
6 Aug 2021Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978Intuitive Surgical, Inc.DeviceClass II1
6 Aug 2021TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the…Johnson & Johnson Surgical Vision IncDeviceClass II1
6 Aug 2021Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237ZOLL Circulation, Inc.DeviceClass II28
4 Aug 2021Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen ProbesAbbott Molecular, Inc.DeviceClass II1
2 Aug 2021Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, cleanable) 2087640-001 FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG (gray, autoclavable)…GE Healthcare, LLCDeviceClass II2
2 Aug 2021uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.Shanghai United Imaging Healthcare Co., Ltd.DeviceClass II2
29 Jul 2021LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101, BI2001, BDL2420 Event 88485Lymol Medical CorporationDeviceClass II1
29 Jul 2021Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.Sentinel CH SpADeviceClass III1
28 Jul 2021Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.Corin LtdDeviceClass II10
28 Jul 2021Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116Beckman Coulter Inc.DeviceClass II1
27 Jul 2021Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002 Event 88529Contamac Solutions, Inc.DeviceClass II1
27 Jul 2021REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796Bard Peripheral Vascular IncDeviceClass II1
27 Jul 2021Grab & Go Bistro Pimento Cheese Sandwich 5oz plastic container 1 sandwich per package Event 88633Modern Distributors, Inc. dba Modern VendingFoodClass II1
26 Jul 2021Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for…Paltop Advanced Dental Solutions LtdDeviceClass II6
21 Jul 2021DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118Beckman Coulter Inc.DeviceClass II1
21 Jul 2021MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868 Event 88585Implant Resource IncDeviceClass II1
16 Jul 2021ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton) Event 88335Alpha-Tek LLCDrugClass I1
14 Jul 2021Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 (OZ) (141 g) aerosol can, Distributed by: Johnson & Johnson Consumer Inc., Skillman, NJ 08558 UPC 3 8137-119462 9Johnson & Johnson Consumer, Inc.DrugClass I20
8 Jul 2021The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 14 x 8mm, Bifurcate 45cm,…Vascutek, Ltd.DeviceClass II2
24 Jun 2021AMX Navigate Mobile X-Ray SystemGE Healthcare, LLCDeviceClass II1
24 Jun 2021CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.CardioQuip, LLCDeviceClass II1
18 Jun 2021Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000WOM World of Medicine AGDeviceClass II1
10 Jun 2021Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (model no. INDIJAA) beds manufactured without IndiGo modules assembled at the time of manufacturing and…ARJOHUNTLEIGH POLSKA Sp. z.o.o.DeviceClass II1
17 May 2021Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715ADRIA SRLDeviceClass II3
12 May 2021CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103CardioQuip, LLCDeviceClass II4
16 Apr 2021PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SUAesculap Implant Systems LLCDeviceClass II2
9 Feb 2021Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861APhilips North America LLCDeviceClass II4
8 Dec 2020smiths medical portex Loss of Resistance Device, REF 100/398/000Smiths Medical ASD Inc.DeviceClass II1
11 Nov 2020Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000ACanon Medical System, USA, INC.DeviceClass II1
14 Jul 2020CADD Administration Sets, Model #21-7346-24Smiths Medical ASD Inc.DeviceClass II1
24 Apr 2020AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103Angiodynamics, Inc.DeviceClass II1
24 Mar 2020CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n.…Smiths Medical ASD Inc.DeviceClass I1
10 Mar 2020medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1Smiths Medical ASD Inc.DeviceClass II12
1 Nov 2019BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101Bio-Rad Laboratories, Inc.DeviceClass II1
10 May 2018medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-101RESmiths Medical ASD Inc.DeviceClass II1
17 Oct 2017Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power…Angiodynamics Inc. (Navilyst Medical Inc.)DeviceClass II1

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 October 2021 has the most units?
Campaign 21V800000, with 194,546 units. NHTSA received the report on 14 Oct 2021.
Which CPSC recall of October 2021 has the most units?
CPSC recall 22009, with about 67,000 units. The CPSC title is: myCharge Recalls Powerbanks Due to Fire and Burn Hazards
How many FDA recalls of October 2021 are in Class I?
27 of the 154 FDA enforcement events with a report date in October 2021.
Which date puts a recall in October 2021?
For NHTSA, the date NHTSA received the report. For CPSC, the recall date. For FDA, the first report date of the event.