| 15 Mar 2022 | Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310 | Teligent Pharma, Inc. | Drug | Class II | 37 |
| 14 Mar 2022 | Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-474-15 | Athenex Pharma Solutions, LLC | Drug | Class II | 7 |
| 10 Mar 2022 | ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.), NDC 74492-0002-1; b) 3785 mL/1 gallon NDC 74492-0002-2; c) 236 mL/8 oz. NDC 74492-0002-3; d) 473 mL/16 oz. NDC 74492-0002-4; Made in USA Rock Town Distillery, 1201 Main Street Little Rock, Arkansas… Event 89774 | Rock Town Distillery, Inc. | Drug | Class II | 1 |
| 10 Mar 2022 | Rosarita Organic Refried Beans Multipack carton containing 8 - 16oz cans | ConAgra Foods, INc. | Food | Class II | 1 |
| 9 Mar 2022 | Albanese Dark Chocolate Espresso Bean packaged into 9oz plastic tubs 12 tubs per case | Albanese Confectionery Group, Inc. | Food | Class I | 1 |
| 8 Mar 2022 | Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0059-00 | Olympia Compounding Pharmacy dba Olympia Pharmacy | Drug | Class II | 7 |
| 8 Mar 2022 | Shredded Cheese consisting of Monterey Jack, Queso Quesadilla, and Asadero cheeses, Net Wt 2lbs, packaged in plastic pouches, 12 pouches per case. | Schreiber Foods Inc | Food | Class II | 1 |
| 8 Mar 2022 | Kit Thai Noodle Salad FM; Net weight 6.75 lbs. UPC 0-20728-72698-0. Product is RTE, refrigerated, ready to mix by the retailer for sale at the retail store. Product comes in a kit that contains Thai Noodle Salad Base (recalled by Fresh Creative Foods; RES 89741), brussels/carrot blend in a plastic bag, and broccoli… | Pacific Coast Fruit Company | Food | Class II | 1 |
| 8 Mar 2022 | Stutzman Farms Sprouted Einkorn Crackers sold in .30lb and 1lb bags | Stutzman Farms | Food | Class II | 7 |
| 7 Mar 2022 | Fresh Creative Foods THAI PEANUT DRESSING R&G 80/2.5 OZ UPC: 10013454378387 Item # 402464 Perishable/Keep refrigerated | RMJV, LP dba Fresh Creative Foods | Food | Class II | 9 |
| 7 Mar 2022 | Overnight Oats, net wt. 9.4 oz. It is packaged in flexible plastic bowl with film lid. Product label is read in parts: "***OVERNIGHT OATS***Ingredients: 1% Greek Yogurt ***Coconut Milk, Orgain Organic Protein, Rolled Oats, Almond, Milk, Honey, Flaxseeds, Coconut***Contains: Milk***Made in a kitchen that uses eggs,… | HumbleHungryHappy LLC | Food | Class II | 5 |
| 4 Mar 2022 | Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zurich, IL 60047 | Fresenius Kabi USA, LLC | Drug | Class I | 1 |
| 4 Mar 2022 | Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60 | Direct Rx | Drug | Class II | 2 |
| 4 Mar 2022 | Swanson Ultra: Vitamin B12 Methylcobalamin High Absorption 60 serving per container, Item Code SWU122, UPC 87614-02122. Distributed by Swanson Health Products Fargo, ND 58104. 60 cc green PETE plastic bottle with black 33 induction seal cap | Swanson Health Products, Inc | Food | Class II | 1 |
| 3 Mar 2022 | HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01 | Tennessee Technical Coatings, Corp. | Drug | Class I | 2 |
| 3 Mar 2022 | Sprouts Farmers Market Dark Chocolate Covered Cherries; Dried Cherries covered in Rich Dark Chocolate. Net Wt. 12 oz (340g) Item # 638-011 UPC: 6 46670 46342 6 Processed in a facility that processes on shared equipment with peanuts, tree nuts, wheat and milk. Distributed by Sprouts Farmers Market, Phoenix, AZ | Torn & Glasser, Inc. | Food | Class I | 1 |
| 2 Mar 2022 | Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18. | Golden State Medical Supply Inc. | Drug | Class II | 1 |
| 2 Mar 2022 | HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown bottles with brown colored closures. Distributed by HEB San Antonio, TX 78204. UPC 0 41220 25111 7 | Vi-Jon, Inc. | Drug | Class II | 1 |
| 1 Mar 2022 | Herbalife NutritionProtein Bar Deluxe - Chocolate Peanut flavor. 14 bars per carton Protein-based snack for energy and nutrition 14 bars 1.23 oz (35 g) each Net wt. 17.3 oz., (490 g) SKU: 0365US Catalog Number: 0365 Formulated and Distributed by Herbalife International of America, Inc. Los Angeles, CA Manufactured by… Event 89674 | Herbalife International of America | Food | Class II | 1 |
| 1 Mar 2022 | Del Monte Bubble Fruit - Tropical Mixed Fruit Cup Snacks. Mixed fruit and popping boba with sweetened juice. 3.5 0z (4 pack), 6 x 4 pack sleeves per carton UPC: 24000 25236 | DEL MONTE FOODS INC | Food | Class II | 1 |
| 28 Feb 2022 | PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61 | The Harvard Drug Group | Drug | Class II | 1 |
| 28 Feb 2022 | Port City Soups Creole Gumbo 32oz glass mason jar sold by individual unit | Name withheld | Food | Class II | 5 |
| 25 Feb 2022 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | CELLTRION USA INC | Device | Class II | 1 |
| 25 Feb 2022 | ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST. | Brainlab AG | Device | Class II | 1 |
| 25 Feb 2022 | Mycoplasma genitalium Control Panel (Inactivated Pellet) | Microbiologics Inc | Device | Class II | 1 |
| 25 Feb 2022 | 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20 | B. Braun Medical, Inc. | Drug | Class II | 1 |
| 25 Feb 2022 | Damascus Bakery, Bantam Classic Bagels, 6/1.3 oz pieces per carton (7.8 oz), Paper Carton . Event 89719 | Damascus Bakery LLC | Food | Class II | 1 |
| 25 Feb 2022 | Chicago Sweet Connections: Paczkis - Apple Flavor packaged in a clear plastic clamshell 4 pack | Chicago Sweet Connections, Inc. | Food | Class II | 20 |
| 24 Feb 2022 | hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61 | The Harvard Drug Group | Drug | Class II | 1 |
| 24 Feb 2022 | Snak Yard Dried Plums Saladitos; 12.7 oz. net wt (360g) Item number 1546905 UPC: 8 10019 60082 1 Made in China; Packed in Thailand Distributed by Alli & Rose LLC, 1422 E, ?M?ain St. PMB #210 Lincolnton NC 28092 Event 89661 | ALLI & ROSE LLC | Food | Class II | 1 |
| 23 Feb 2022 | Factor 75 - Fiery Beef & Black Bean Chili 12.7oz plastic tray sold as single serve meal to end consumer Event 89688 | FACTOR | Food | Class II | 1 |
| 23 Feb 2022 | 14" Raw Buttermilk Breakfast Tart with Cranberries, Apples & Granola P2004 (9 Frozen Pancakes). Barcode: 0106915030162004992201921137 | Gourmet Kitchen, Inc. | Food | Class I | 2 |
| 23 Feb 2022 | Bob Evan's Sour Cream & Chive Mashed Potatoes 24oz plastic trays with clear film and sleeve over wrap sold as singles to consumers Event 89649 | Name withheld | Food | Class II | 1 |
| 23 Feb 2022 | Banana Coconut Rum Cake | Edible Spirits, Inc | Food | Class II | 5 |
| 23 Feb 2022 | Enoki Mushrooms, brand Xuerong, net wt. 150 g/ 5.25200g/7.05-ounce packages, UPC 6953150110157. 34 0er carton. | GOLDEN MEDAL MUSHROOM INC | Food | Class I | 1 |
| 22 Feb 2022 | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40 | American Health Packaging | Drug | Class II | 1 |
| 22 Feb 2022 | Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical. | Preferred Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 22 Feb 2022 | Great Value Restaurant Style White Corn Tortilla Chips, Net St. 13 oz. UPC 78742-11453. Distributed By: Walmart, Inc. Bentonville, AR 72716. | Shearer'S Snacks | Food | Class II | 1 |
| 21 Feb 2022 | Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08. | Morton Grove Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 20 Feb 2022 | Vadilal Quick Treat Custard Apple Pulp Net Wt, 1kg/35.27-oz. Product code FPEP44302 UPC:8901777282168 Best Before September 2023 Event 89630 | Vadilal Industries USA Inc. | Food | Class I | 1 |
| 19 Feb 2022 | Coca-Cola Cherry Zero Sugar Fridge Pack, 12 - 12 FL OZ CANS (144 FL OZ) in a 12-pack fridge pack carton. UPC 049000047516; UPC Cherry Coca-Cola Zero Sugar can 049000047561; Cherry Coca-Cola can 04905004. There are 2 12-packs per case. | Swire Coca Cola USA | Food | Class II | 1 |
| 18 Feb 2022 | Medical Device products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee. The general categories of products, but are limited to these products, includes: feminine hygiene products, surgical masks, contact lens cleaning solutions, bandages, nasal… | Dollar Tree Distribution, Inc. | Device | Class II | 1 |
| 18 Feb 2022 | All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee. | Dollar Tree Distribution, Inc. | Drug | Class II | 1 |
| 18 Feb 2022 | Food products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee | Dollar Tree Distribution, Inc. | Food | Class II | 2 |
| 18 Feb 2022 | Honey BBQ Snack, NO MSG Seasoning packaged in the following sizes: 1. 685-A, Net Wt 21 lbs. (9.52kg). Part #020001456. 2. 685-B, Net Wt 5.25 lbs. (2.38kg). Part #020001457. Ingredients: Sugar, Salt, Dried Honey, Spices, Brown Sugar, Onion and Garlic Powder, Dextrose, Natural Smoke Flavor, Dried Molasses, Natural… | PS Seasoning & Spices, Inc. | Food | Class III | 5 |
| 18 Feb 2022 | Wegmans brand Roasted Garlic hummus; NET WT 32 OZ (2 LB) 908 g; packaged in clear plastic container with a clear plastic snap lid; Keep Refrigerated | Wegmans Food Markets, Inc. | Food | Class II | 1 |
| 17 Feb 2022 | Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton). Event 89626 | Name withheld | Drug | Class III | 1 |
| 17 Feb 2022 | Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05 | Direct Rx | Drug | Class II | 1 |
| 17 Feb 2022 | Flow Alkaline Spring Water - Organic lemon & ginger flavored water. 500 ml 12 units per case . Tetra Pak paper carton. | Flow Beverages Inc. | Food | Class II | 2 |
| 17 Feb 2022 | Taiyaki Variety Pack; 21.6 oz. (600g) 30 fish waffles in a units, 27 master cased to a pallet, 40 pallets to container. Item Number 1598329, UPC: 8 50013 07258 3 Three flavors: Chocolate Cream, Vanilla Custard and Red Bean & Cinnamon. Manufactured for Suji's Korean Cuisine, Seattle, WA Country of Origin: Republic of… Event 89615 | FDMR, INC DBA SUJI'S KOREAN CUISINE | Food | Class II | 1 |
| 17 Feb 2022 | Abbott EleCare Infant Formula Unflavoured 400g can. 6 cans per case. Item number 5466539 Retail unit UPC 070074104591 | Abbott Laboratories | Food | Class I | 41 |
| 16 Feb 2022 | Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07. | Macleods Pharma Usa Inc | Drug | Class II | 1 |
| 16 Feb 2022 | Signature Select Cookie Dough Ice Cream Vanilla Flavored ice cream with chocolate flavored chips and chunks of chocolaty chip cookie dough. Artificial Flavor added. 1.5 qt. paper container. 6 retail units per case. UPC 2113008803 Some container were filled with Black Walnut Ice cream. Lid correctly identified product… | Albertsons Companies LLC | Food | Class II | 1 |
| 15 Feb 2022 | ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235 | Ion Beam Applications S.A. | Device | Class II | 1 |
| 15 Feb 2022 | Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System. | Wright Medical Technology, Inc. | Device | Class II | 1 |
| 15 Feb 2022 | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-192-07. | Macleods Pharma Usa Inc | Drug | Class II | 1 |
| 14 Feb 2022 | Compella Bariatric Bed System | Baxter Healthcare Corporation | Device | Class II | 2 |
| 14 Feb 2022 | BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and… | Biomet, Inc. | Device | Class II | 4 |
| 14 Feb 2022 | Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 | Cytocell Ltd. | Device | Class III | 1 |
| 14 Feb 2022 | Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare Central Pharmacy 7802 E. Telecom Parkway Temple Terrace, FL 33637 (813) 901-6392 | BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy | Drug | Class III | 1 |
| 12 Feb 2022 | Nature's Eats Balance Hearty Mix 16 oz. UPC 832112003842 packaged in cello bag 5 bags per case | Texas Star Nut and Food Co., Inc. | Food | Class I | 2 |
| 11 Feb 2022 | Alinity m Integrated Reaction Units (IRU) | Abbott Molecular, Inc. | Device | Class II | 1 |
| 11 Feb 2022 | Diastatic Malt Powder 50lb bag - up to 50 bags per pallet Malt Products Corporation Event 89597 | Malt Products Corporation | Food | Class II | 1 |
| 10 Feb 2022 | RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1. Event 89606 | Positive Health | Drug | Class I | 1 |
| 10 Feb 2022 | Salted Dried Plums, 500kgcartons, 20kgs plastic bag/carton Event 89608 | Vbest Inc | Food | Class II | 1 |
| 10 Feb 2022 | Favorite Day Carrot cake soft bake cookies Net Wt 8 oz. (227g) UPC 0 885239 25803 3 packaged in gable top carton 6 units per case Event 89593 | J & M Foods, Inc. | Food | Class II | 1 |
| 10 Feb 2022 | Ardent Mills Hotel and Restaurant All Purpose Flour - AA, 50 lb. (22.68kg) bag, UPC 6 78008 00053 9, Ardent Mills, Denver, CO 80202. Milled in Alton, IL. | Ardent Mills, LLC | Food | Class II | 1 |
| 9 Feb 2022 | The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from… | Wright Medical Technology, Inc. | Device | Class II | 1 |
| 9 Feb 2022 | Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton. Event 89686 | Walmart Stores | Drug | Class I | 1 |
| 9 Feb 2022 | Fresh Enoki Mushrooms 5.25oz/150 g/ 34 packages per case UPC: 001958939091 Distributed by Concord Farms, Vernon, CA Do not eat raw. Event 89574 | Concord Farms, Inc. | Food | Class I | 1 |
| 8 Feb 2022 | BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack | Bio-Rad Laboratories, Inc. | Device | Class II | 2 |
| 8 Feb 2022 | Taiwan Best Quality Enoki Natural Mushrooms, Premium 200g/7.5 oz. clear plastic package. 50 pcs per box. Manufacturer: Changhua County Mushroom Production Cooperative; Distributed by Jan Fruits. UPC: 8 51084 00835 8 | Jan Fruits, Inc. | Food | Class I | 1 |
| 7 Feb 2022 | PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U | B Braun Medical Inc | Device | Class II | 1 |
| 7 Feb 2022 | Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01 | RISING PHARMACEUTICALS | Drug | Class II | 1 |
| 7 Feb 2022 | 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ 07726, www.tsmbrands.com, Made in Turkey, UPC 868275965765 | Tsm Brands LLC | Drug | Class II | 2 |
| 7 Feb 2022 | American Gourmet Saladitos (Dried Salted Plums) 1.5 oz. package UPC: 1578600104 Event 89582 | American Gourmet | Food | Class II | 1 |
| 7 Feb 2022 | Tolteca Saladitos Salted Dried Plums; Net Wt. 1.5 oz. (42.5g) packaged in a clear cellophane bag approximately (4 x 8 ). The name SALADITOS Salted Dried Plums appears on a Blue TOLTECA brand label and identified with UPC Code 704927600694 Packed by Candies Toletca P.O. Box 4055, Fresno, CA 93744 | Name withheld | Food | Class II | 2 |
| 7 Feb 2022 | Weis Original Potato Salad, Net Wt 64 oz (4 lb) 1.81kg. UPC 41497-19347. Keep Refrigerated | Garden-Fresh Foods, Inc. | Food | Class I | 1 |
| 7 Feb 2022 | Jaguar Power Honey packaged in a gold paper box with black writing, 12 sachets per box UPC 3553314142227 | Name withheld | Food | Class I | 2 |
| 6 Feb 2022 | LUPAG brand Plain Dried Salted Plums, net wt. 0.5oz, pre-priced at $.99 packaged in transparent poly bags sealed with a cardboard header, stapled one dozen packages on a cardboard strip. UPC 7 25535 01133 7. Ingredients: Dried Prunes, salt. Origin: Taiwan or China Rojas Incorporated Los Angeles, CA 90023 Event 89546 | Rojas Inc. | Food | Class II | 1 |
| 4 Feb 2022 | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature. | ev3 Inc. | Device | Class I | 2 |
| 4 Feb 2022 | TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A | Cytocell Ltd. | Device | Class III | 1 |
| 4 Feb 2022 | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 30 Individual Maxi Swabsticks per carton, 10 boxes of 30 Individual Swabsticks per case, NDC 10819-4076-4, REORDER NO. S41950; b) One Maxi… | Professional Disposables International, Inc. | Drug | Class II | 3 |
| 3 Feb 2022 | Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using… | Abbott Laboratories, Inc | Device | Class II | 1 |
| 3 Feb 2022 | Dried salted plum, packaged in 22 lbs. carton. Product of China. Event 89541 | Pacific Golden Coast Trading Inc | Food | Class II | 1 |
| 3 Feb 2022 | Saladitos With Chili, Net Weight 16 oz (1lb) with UPC 0661799748162. The product is packaged in ultra clear sealed zip-lock plastic bag. There is no expiry date and no lot code. Event 89537 | A & E Corrales LLC | Food | Class II | 1 |
| 3 Feb 2022 | Whole Foods Market Vanilla Short Bread Cookies packaged in clear plastic container with a white scale label applied PLU 66705 | Whole Foods Market Brand 365, Llc | Food | Class I | 1 |
| 2 Feb 2022 | NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250 | Ace Surgical Supply Co., Inc. | Device | Class II | 1 |
| 2 Feb 2022 | La Fiesta brand, Salted Plums with Chili Product. Product is packaged in cello bags, net wt. 1oz. UPC 0 32327 02829 0. There are 8 dozens per case. Product is labeled in parts: "***SALADITOS CON CHILE *** SALTED PLUMS WITH CHILI ***PRODUCT OF CHINA***Distributed By: La Fiesta Food Products, Inc. San Jose, CA 95122***". | la fiesta food products | Food | Class II | 1 |
| 2 Feb 2022 | EL Leoncito brand Dry Salted Plum, Shelf Stable, packaged in plastic bag, Net Wt 1.4oz, UPC 8-52605-00024. 12 packs with 12 units per case - 144 total units El Super Leon brand Dry Salted Plum, Shelf Stable, packaged in plastic bag, Net Wt 1.4oz, UPC 8-52605-00407. The label is read in parts: "Manufactured by: El… | El Super Leon Ponchin Snacks, Inc. | Food | Class II | 2 |
| 2 Feb 2022 | El Chavito Saladitos Dried Salted Plums, net wt. 1.7 oz bag, Individual UPC 859470006049, Master Case UPC 859470006629. El Chavito Saladitos Dried Salted Plums, net wt. 1.7 oz bag, Individual UPC 850013297221, Master Case UPC 850013297726. | Name withheld | Food | Class II | 2 |
| 1 Feb 2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 | BioPro, Inc. | Device | Class II | 10 |
| 1 Feb 2022 | All Ice Cream and Ice Cream products within expiry; manufactured by Royal Ice Cream Company; manufactured in Manchester, CT; all effected products will have the manufacturing plant number "CT121" or "CT #121"; RETAIL BRANDS EFFECTED: Batch brand pints, all flavors; Royal Ice Cream brand half gallons, pints, cakes,… Event 89514 | The Royal Ice Cream Company Inc. | Food | Class I | 1 |
| 31 Jan 2022 | STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample. Event 89527 | SD Biosensor, Inc. | Device | Class I | 1 |
| 31 Jan 2022 | Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials. | B. Braun Medical, Inc. | Device | Class II | 1 |
| 28 Jan 2022 | GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001. | GE Healthcare, LLC | Device | Class II | 1 |
| 28 Jan 2022 | SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 Event 89510 | Sam Medical Products | Device | Class II | 1 |
| 28 Jan 2022 | Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S Event 89555 | Brasseler USA, Medical L.L.C. | Device | Class II | 1 |
| 28 Jan 2022 | Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles packaged as (a) 2 OZ / 60ML, UPC 8 19192 02865 1; (b) 4 OZ, 118 ML, UPC 8 19192 02826 2; (c) 16 OZ, 473 ML, UPC 8 19192 02874 3; (d) 1 gallon, UPC 8 19192 02830 9; Premium Nature, South Plainfield, NJ. | AMS Packaging Inc | Drug | Class II | 2 |
| 27 Jan 2022 | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C | C.R. Bard Inc | Device | Class II | 2 |
| 27 Jan 2022 | Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA | Hologic, Inc | Device | Class II | 1 |
| 27 Jan 2022 | HeartWare Ventricular Assist Device (HVAD) System | Heartware, Inc. | Device | Class II | 1 |
| 26 Jan 2022 | Dunkin Caramel Swirl: 6x 64 fl. oz. per case. Product number 4862 UPC case: 10045796048628 Ingredients: Sweetened condensed nonfat milk, high fructose corn syrup, sugar water, brown sugar, caramel color, natural flavors, potassium sorbate (a Preservative), salt. Allergens: Milk Dunkin Mocha Swirl label on inside… | Lyons Magnus, Inc | Food | Class I | 1 |
| 25 Jan 2022 | CoolSeal Generator, REF: CSL-200-50 Event 89570 | Bolder Surgical, LLC | Device | Class II | 1 |
| 25 Jan 2022 | meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis. | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 25 Jan 2022 | REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670 Event 89481 | Blaine Labs Inc | Drug | Class I | 1 |
| 24 Jan 2022 | Philips Respironics V60 Ventilator Part Number 1053617 | Respironics California, LLC | Device | Class I | 2 |
| 21 Jan 2022 | REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder | Stryker Sustainability Solutions | Device | Class II | 1 |
| 21 Jan 2022 | Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Product umber: 826614 | Integra LifeSciences Corp. | Device | Class II | 2 |
| 21 Jan 2022 | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date. | NeuMoDx Molecular Inc | Device | Class II | 1 |
| 21 Jan 2022 | Tortillas Arillis, Arillis Corp, Contains: 10 (ten) tortillas Event 89467 | ARILLIS CORP | Food | Class II | 1 |
| 20 Jan 2022 | PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers. Event 89534 | Envisiontec US Llc | Device | Class II | 1 |
| 20 Jan 2022 | Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000 | Outset Medical, Inc. | Device | Class II | 1 |
| 20 Jan 2022 | Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer | Bard Peripheral Vascular Inc | Device | Class II | 11 |
| 19 Jan 2022 | Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological… | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 19 Jan 2022 | Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62 | Name withheld | Drug | Class III | 3 |
| 18 Jan 2022 | LINQ II Insertable Cardiac Monitor | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class II | 1 |
| 18 Jan 2022 | Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024 | Cytocell Ltd. | Device | Class II | 1 |
| 17 Jan 2022 | OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment | Lacrimedics Inc | Device | Class II | 2 |
| 14 Jan 2022 | (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR… | Hill-Rom, Inc. | Device | Class II | 1 |
| 14 Jan 2022 | CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex | Carl Zeiss Meditec, Inc. | Device | Class II | 1 |
| 14 Jan 2022 | 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used. | Stryker Corporation | Device | Class II | 1 |
| 14 Jan 2022 | HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070 | Maquet Cardiovascular, LLC | Device | Class II | 1 |
| 14 Jan 2022 | BUTLER Clear Dip, 12 bottles/case | Sunstar Americas, Inc. | Device | Class II | 1 |
| 13 Jan 2022 | HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak | Physio-Control, Inc. | Device | Class III | 1 |
| 13 Jan 2022 | LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test) | Lusys Laboratories, Inc. | Device | Class I | 3 |
| 13 Jan 2022 | Everest MI XT Inner Dilator, Catalog Number 5101-90167 | K2M, Inc | Device | Class II | 2 |
| 13 Jan 2022 | Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile | ROi CPS LLC | Device | Class II | 1 |
| 13 Jan 2022 | Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT | Nextremity Solutions | Device | Class II | 2 |
| 11 Jan 2022 | Lung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung Cleaner LLC Boulder, CO 80302 Event 89635 | Pharmasol Corporation | Drug | Class II | 1 |
| 10 Jan 2022 | Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format | Remel Inc | Device | Class II | 1 |
| 7 Jan 2022 | NavitrackER Kit A: Knee, Model Number 20-8000-000-07, | Orthosoft, Inc. dba Zimmer CAS | Device | Class II | 1 |
| 7 Jan 2022 | Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301 | Biomet, Inc. | Device | Class II | 8 |
| 6 Jan 2022 | BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 36490200 | Becton Dickinson & Company | Device | Class III | 1 |
| 6 Jan 2022 | Dole 10oz Very Veggie UPC: 0-71430-01008-2 SKU: 532 | Dole Fresh Vegetables Inc | Food | Class I | 55 |
| 4 Jan 2022 | The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in… | BALT USA, LLC | Device | Class II | 1 |
| 31 Dec 2021 | Purim Health Brands EpiGenius Kids Chocolate: Daily Superfood 630 g pouches Suggested Use: Mix approximately three tablespoons with 8-10 ounces of cold water. Shake vigorously or blend. For a creamier texture, mix with your favorite non-diary milk or in smoothie. This delicious rich chocolate shake can be enjoyed any… | Organic By Nature, Inc. | Food | Class II | 1 |
| 30 Dec 2021 | RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 . Including Service Paks: Product name (build number) UDI-DI… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 29 Dec 2021 | MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 | Stryker Leibinger GmbH & Co. KG | Device | Class II | 1 |
| 29 Dec 2021 | MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 28 Dec 2021 | Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the… | Hobbs Medical, Inc. | Device | Class II | 1 |
| 28 Dec 2021 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | CELLTRION USA INC | Device | Class I | 1 |
| 23 Dec 2021 | da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11 | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 22 Dec 2021 | NIM TRIVANTAGE EMG Endotracheal Tube | Medtronic Xomed, Inc. | Device | Class II | 1 |
| 22 Dec 2021 | Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040 | Boston Scientific Corporation | Device | Class II | 31 |
| 21 Dec 2021 | Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C120EE; ENBF2513C145EE; ENBF2513C170EE; ENBF2516C120EE; ENBF2516C145EE; ENBF2516C170EE;… | Medtronic Vascular, Inc. | Device | Class II | 1 |
| 17 Dec 2021 | NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R | Nobel Biocare Usa Llc | Device | Class II | 1 |
| 17 Dec 2021 | Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device. | LivaNova Deutschland GmbH | Device | Class III | 1 |
| 16 Dec 2021 | Digital Angiography System Bransist safire Generator Model D150GC-40 | Shimadzu Medical Systems | Device | Class II | 2 |
| 15 Dec 2021 | 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box | CellEra LLC | Device | Class III | 5 |
| 13 Dec 2021 | DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45 | Collagen Matrix, Inc. | Device | Class II | 2 |
| 10 Dec 2021 | VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box. | Ortho-Clinical Diagnostics, Inc. | Device | Class II | 1 |
| 8 Dec 2021 | AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850 | Beckman Coulter Inc. | Device | Class II | 1 |
| 7 Dec 2021 | Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05 | Direct Rx | Drug | Class II | 1 |
| 2 Dec 2021 | IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | Device | Class II | 1 |
| 2 Dec 2021 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | CELLTRION USA INC | Device | Class I | 1 |
| 1 Dec 2021 | Michels Transport Medium, 20ML Prefilled Cont | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 24 Nov 2021 | Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027,… | Philips North America Llc | Device | Class II | 2 |
| 5 Nov 2021 | DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN, Quick Reference Guide DigniCap Delta… Event 89056 | Dignitana, Inc. | Device | Class II | 1 |
| 26 Oct 2021 | Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 50941-009-43 | Perrigo Company PLC | Drug | Class II | 51 |
| 8 Sep 2021 | TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30 | Akorn, Inc. | Drug | Class II | 1 |
| 26 May 2021 | Azurion systems with software release R2.0.x | Philips Healthcare | Device | Class II | 1 |
| 6 Aug 2020 | Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc. | Name withheld | Drug | Class II | 12 |
| 2 Dec 2019 | PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006 Event 89577 | 3-D Matrix, Inc. | Device | Class II | 1 |
| 12 Jun 2018 | Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport… | Philips Respironics, Inc. | Device | Class I | 1 |
| 6 Jun 2017 | Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derived from CDC 2010C-3114 (STEC), 4. C. jejuni… | Microbiologics Inc | Device | Class II | 5 |
| 20 Apr 2016 | Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift Event 88610 | Acorn Stairlifts, Inc | Device | Class II | 1 |
| 1 Dec 2015 | QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 4.… | Microbiologics Inc | Device | Class II | 2 |
| 17 Jul 2015 | LYFO Disk | Microbiologics Inc | Device | Class III | 1 |
| 6 Oct 2014 | KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299 | Microbiologics Inc | Device | Class II | 3 |