| 15 Feb 2022 | Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 | ANI Pharmaceuticals, Inc. | Drug | Class II | 5 |
| 11 Feb 2022 | HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831 Golf Dr., Houston, TX 77018, NDC: 88888-1739-01. | Revive Rx LLC dba Revive Rx Pharmacy | Drug | Class I | 1 |
| 9 Feb 2022 | Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36. | Lannett Company, Inc. | Drug | Class II | 1 |
| 9 Feb 2022 | Pretty Thai Sweet Chili Stir Fry & Barbecue Sauce NET WT. 11.2 oz (317g) UPC 860043001224 packaged in a cylindrical clear PET plastic bottle Event 89583 | Ponder Foods LLC | Food | Class II | 1 |
| 8 Feb 2022 | RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5. Event 89563 | Name withheld | Drug | Class I | 1 |
| 8 Feb 2022 | MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191. | ABC Sales 1 Inc | Drug | Class I | 2 |
| 8 Feb 2022 | THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1. Event 89579 | Your Favorite Shop | Drug | Class I | 1 |
| 7 Feb 2022 | Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-053-66. | Teligent Pharma, Inc. | Drug | Class II | 1 |
| 7 Feb 2022 | Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-648-88. | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 4 Feb 2022 | PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51285-204-01 | CooperSurgical, Inc | Drug | Class I | 1 |
| 4 Feb 2022 | MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88 Event 89543 | Junp Hydration LLC | Drug | Class I | 1 |
| 4 Feb 2022 | Enoki Mushrooms, brand Xuerong, net wt. 200g/7.05-ounce packages, UPC 6 953150 100684. Product sent to distributor is packaged in a brown cardboard master case. The product name "ENOKI MUSHROOM" and other information in Chinese are printed in green color. The code "300511" is printed in blue color. | GOLDEN MEDAL MUSHROOM INC | Food | Class I | 1 |
| 3 Feb 2022 | HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0104-05. | STAQ Pharma, Inc. | Drug | Class I | 2 |
| 1 Feb 2022 | Organic Roasted Salted Cashews, Net Weight of 6 oz (170g), UPC 6 16316 76283 1. Product is packed in a brown kraft stand-up paper pouch with plastic front viewing window with a zip-lock top that was heat sealed to close. The labeled cashew package has the ingredient statement of "Organic Cashews, Organic Extra Virgin… | Honey Heaven Wholesale Inc | Food | Class II | 1 |
| 28 Jan 2022 | HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59 Event 89501 | Esupplementsales, LLC | Drug | Class I | 1 |
| 28 Jan 2022 | Wishbone Thousand Island Dressing 15oz. bottle UPC 0-41321-00645-6 and 24 oz. bottle UPC 0-41321-00731-6; six bottles per case | CONAGRA BRANDS | Food | Class I | 2 |
| 27 Jan 2022 | E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit Event 89485 | E25Bio, Inc. | Device | Class I | 1 |
| 26 Jan 2022 | Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10 | AuroMedics Pharma LLC | Drug | Class I | 1 |
| 26 Jan 2022 | 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00 | ULTRAtab Laboratories, Inc. | Drug | Class II | 33 |
| 26 Jan 2022 | Kirkland Signature Organic Soy Non-Dairy Beverage Vanilla; 12- 32 oz. cartons (note- 12 count consumer display case) SunOpta Item number 1243803 Individual Carton UPC: 0 96619 99861 6; 12 x 32 oz. container carton UPC: 096619 49000 4 Ambient, keep refrigerated after opening. Best if used within 7 10 days after… | SunOpta Grains and Foods Inc. | Food | Class II | 1 |
| 26 Jan 2022 | Siren Birthday Cake Protein Bites, Item # 1104, brand Siren Snacks, packaged in 1.7 oz (48g) plastic pouch, 10 individual pouches per caddie. Caddie UPC: 8-62768-00049-0; Pouch UPC: 8 62768-00048-3. The affected label is read in parts: "***12G PLANT PROTEIN***INGREDIENTS: Plant Protein Blend (Pea Protein, Almond… Event 89484 | Siren Snacks | Food | Class I | 1 |
| 26 Jan 2022 | Simply Good Proteins Collagen Protein Hydrolyzed Protein Powder 15g Protein NET WT. 15.5oz (.97lb) 440g . UPC code: 8 5782600866 2 Packed in HDPE Plastic. Simply Good Collagen Protein Hydrolyzed Protein Powder 25g Protein NET WT. 31.3oz (1.96lb) 888g UPC code: 8 57826008655 2 Packed in HDPE Plastic. Expiration Date:… | Naomi Whittel Brands, LLC | Food | Class II | 3 |
| 25 Jan 2022 | Quesos La Ricura Mi Ranchito Fresh Cheese with Hot Peppers, 14. 0z. Event 89480 | Quesos La Ricura, Ltd. | Food | Class II | 1 |
| 24 Jan 2022 | 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6" | Argon Medical Devices, Inc | Device | Class II | 1 |
| 24 Jan 2022 | Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040 | Ultra Seal Corporation | Drug | Class II | 56 |
| 21 Jan 2022 | 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices) | NRT X-RAY A/S | Device | Class II | 1 |
| 21 Jan 2022 | Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, New Jersey 08873-1120, NDC 0037-6822-10. | Mylan Pharmaceuticals Inc | Drug | Class II | 1 |
| 21 Jan 2022 | Driscoll's Conventional Strawberries (Fresh) packed in 8x16oz clamshell and 4X32oz clamshell; 8 clamshells per case, 4 clamshells per case, respectively. Harvest date: Jan-17-2022, Jan-18-2022, Jan-19-2022. | Driscoll's Inc. | Food | Class III | 1 |
| 19 Jan 2022 | Abbys Bakery Homestyle White Bread Dough. Product number 93596. Keep Frozen. 4-1 lb. loaves. Net Wt. 4 lbs. (1.81kg) UPC 40730-93596. Abby's Bakery, Wadena, MN 56482 Event 89452 | Fetting's Frozen Foods LLC | Food | Class II | 1 |
| 19 Jan 2022 | Amy's Vegan Organic Rice Mac & Cheese; frozen; 8 oz. (227 g) individually packaged serving; in trays with plastic overwrap, inside preprinted cardboard boxes; UPC 04227200432; Amy's Kitchen, Inc., P.O.Box 7129, Petaluma, CA 94955 8 or 12 retail units per case; Organic Gluten Free Dairy Free Rice Mac & Cheeze,12Pk,… | Amys Kitchen Inc | Food | Class II | 1 |
| 19 Jan 2022 | Steamable by Lidl Chopped Spinach NET WT 12 OZ (340 g) UPC 4 056489 34380 6. Frozen product. Event 89441 | Frozen Food Development Inc | Food | Class II | 1 |
| 19 Jan 2022 | Dr. Snack Goji Berry; PACKED FOR B.C.S. INTERNATIONAL CORP; 4.5oz, 6oz, 9oz packs clear plastic packs and 5lb cardboard boxes Event 89459 | B.C.S. International Corporation | Food | Class I | 1 |
| 18 Jan 2022 | Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only Event 89482 | Merete Medical GmbH | Device | Class II | 1 |
| 18 Jan 2022 | Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 18 Jan 2022 | Walla Walla Cheese Company Cheddar Curds. Keep Refrigerated. Product is packaged in vacuum sealed zip lock bags. Net wt. 5 lbs. | Walla Walla Cheese Company LLC | Food | Class II | 3 |
| 14 Jan 2022 | Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03 | Aurobindo Pharma USA Inc. | Drug | Class II | 1 |
| 13 Jan 2022 | Lily s Peppermint Flavor Baking Chips, 7 oz. Pouch Event 89427 | LILY'S SWEETS LLC | Food | Class II | 1 |
| 13 Jan 2022 | Korean Sushi, net wt. 12 oz. UPC 0 72148 48043 3. The label is read in parts: "***KOREAN SUSHI ***Ingredients: Rice, Seaweed, Water, Salt, Eggs, Sesame Oil, Spinach, Carrot, Yellow Radish, and Sesame Seed. *** Han Yang Oriental Food Mfg. 3819 94th St. SW, Tacoma, WA 98499 (253) 588-7303***". Event 89421 | Han Yang Corp. | Food | Class II | 1 |
| 13 Jan 2022 | Sugar Plum Vegetable Seasoning Blends Sesame Soy sold in the Veggie Lovers Cooking Kit. 1.5 oz packet. Packaged in a resealable foil bag. UPC:7 4555966500 2 Event 89426 | Sugar Plum Inc. | Food | Class III | 1 |
| 12 Jan 2022 | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 07054, NDC 67877-590-01. | Ascend Laboratories, LLC | Drug | Class II | 1 |
| 12 Jan 2022 | Natural Way Cheese Chive Cheese Curds, retail 12oz plastic bag UPC 8 10056 75107 4, 12 retail units per wholesale case | Natural Way Cheese | Food | Class II | 11 |
| 11 Jan 2022 | Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV)… | TELEFLEX MEDICAL INC | Device | Class I | 7 |
| 10 Jan 2022 | RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleeve. RNAstill Molecular Transport Medium… Event 89374 | BASE 10 GENETICS INC | Device | Class I | 1 |
| 10 Jan 2022 | Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 10 Jan 2022 | Brownie Points Schmurtle 2oz Packaged in food grade cellophane only used as gift basket filler - not sold individually Event 89403 | Brownie Points LLC | Food | Class II | 1 |
| 7 Jan 2022 | Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449 | Baxter Healthcare Corporation | Device | Class II | 11 |
| 7 Jan 2022 | Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28 | Teva Pharmaceuticals USA | Drug | Class III | 2 |
| 6 Jan 2022 | FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth | Envisiontec US Llc | Device | Class II | 2 |
| 6 Jan 2022 | Wayfare Dairy Free Butter Salted & Whipped, Event 89371 | WayFare Health Foods, LLC. | Food | Class II | 1 |
| 6 Jan 2022 | GAT SPORT JETFUEL DIURETIC; FOR RELIEF OF WATER WEIGHT GAIN; Muscle Defining Formula; Stimulant Free Natural Herbal Actives; 90 Oil-Infused Capsules; Dietary Supplement; Other Ingredients: Gelatin (Capsule), Dicalcium Phosphate, Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, Titanium Dioxice… Event 89365 | World Health Products LLC | Food | Class II | 1 |
| 5 Jan 2022 | BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066 | Becton Dickinson & Co. | Device | Class II | 1 |
| 5 Jan 2022 | ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003 | DePuy Orthopaedics, Inc. | Device | Class II | 2 |
| 4 Jan 2022 | INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND | Smith & Nephew, Inc. | Device | Class II | 1 |
| 3 Jan 2022 | eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of… | Philips North America Llc | Device | Class II | 1 |
| 3 Jan 2022 | CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919 | Immuno-Mycologics, Inc | Device | Class II | 1 |
| 30 Dec 2021 | Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044 | Howmedica Osteonics Corp. | Device | Class II | 2 |
| 29 Dec 2021 | Baxter Spectrum IQ Infusion Pumps, Product code 3570009. | Baxter Healthcare Corporation | Device | Class I | 2 |
| 29 Dec 2021 | X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. | XTANT Medical | Device | Class II | 1 |
| 29 Dec 2021 | YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. Event 89330 | Young Dental Mfg Co I LLC | Device | Class II | 1 |
| 29 Dec 2021 | Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05 | Aurobindo Pharma USA Inc. | Drug | Class II | 1 |
| 29 Dec 2021 | WHITE CHEDDAR CHEESE; INGREDIENTS: CULTURED PASTEURIZED MILK, SALT, ENZYMES; Distributed By: G&C Foods; ALLERGEN: MILK; CONTAINS: 1 BAG; Product is for Food Service Only; KEEP REFRIGERATED | G&C Food Distributors & Brokers Inc. | Food | Class II | 2 |
| 28 Dec 2021 | 10 oz. individually wrapped frozen tuna steaks; 4 servings per bag Important: Thaw under refrigeration immediately before use. May contain bones. Product must be cooked prior to consumption KEEP FROZEN AT -18 CELSIUS OR BELOW THAW UNDER REFRIGERATION IMMEDIATELY BEFORE USE. REMOVE FROM PLASTIC PRIOR TO THAWING.… Event 89320 | Relish Foods, Inc. dba Gourmet Fusion Foods | Food | Class II | 1 |
| 28 Dec 2021 | Bake Crafters - Maple Waffle WG Chicken Sausage Packaged into cardboard containers 126 units per case Event 89363 | Name withheld | Food | Class II | 1 |
| 27 Dec 2021 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01 | VIONA PHARMACEUTICALS INC | Drug | Class II | 1 |
| 27 Dec 2021 | Nutricrafters MCT - Instant coconut milk mixer; 1 lb. (454 grams) Ingredients: Medium chain triglycerides, tapioca starch. Allergy information : contains oils from tree nuts (coconut) Suggested use: Stir into drinks or spoon over foods. Start with 1 teaspoon, preferably with meals. Slowly increase amount over several… Event 89419 | NutriCrafters LLC | Food | Class I | 1 |
| 23 Dec 2021 | Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010 | Hill-Rom, Inc. | Device | Class II | 2 |
| 23 Dec 2021 | Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00 | Olympus Corporation of the Americas | Device | Class II | 1 |
| 23 Dec 2021 | GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system. | GE Healthcare, LLC | Device | Class II | 32 |
| 23 Dec 2021 | Delizza BELGIAN MINI CHOCOLATE CREAM PUFFS NET WT. 14.1 oz (400g) 30 CREAM PUFFS PRODUCED IN THE US BY DELIZZA INCORPORATED 6610 CORPORATION PARKWAY, BATTLEBORO, NC 27809 UPC 6 76670 00402 2 | Poppies International INC | Food | Class II | 3 |
| 23 Dec 2021 | Medium Chain Triglyceride (MCT) Powder 50% from Coconut / CocoTrim packaged in 20 kilogram brown bags with plastic inner lining for bulk sale to supplement manufacturers. Exclusively Distributed by Nutralliance / Manufactured by Bio-gen Extracts Pvt. Ltd. Store tightly sealed container at room temperature away from… Event 89300 | Nutralliance Inc | Food | Class I | 1 |
| 22 Dec 2021 | Destino Twist 14F (also branded as Guidestar 14F) | Oscor Inc. | Device | Class II | 1 |
| 22 Dec 2021 | MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL | Avanos Medical, Inc. | Device | Class II | 2 |
| 22 Dec 2021 | CovClear COVID-19 Rapid Antigen Test, ATG 900-031 | Empowered Diagnostics LLC | Device | Class I | 2 |
| 22 Dec 2021 | Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral Recon Nailing System… | Synthes (USA) Products LLC | Device | Class II | 1 |
| 22 Dec 2021 | 8mm FlexDex Needle Driver, Product Code FD-335 ND Event 89316 | FlexDex Inc. | Device | Class II | 1 |
| 22 Dec 2021 | Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. | Philips Respironics, Inc. | Device | Class I | 2 |
| 22 Dec 2021 | Ahold 10oz Chopped Romaine Product UPC 688267011085 | Dole Fresh Vegetables Inc | Food | Class I | 76 |
| 22 Dec 2021 | Sienna Chocolate Decadent Brownie, Net wt. 104 oz. (6-lb. 8 oz.) 2.95 kg., UPC Codes: 8495241115; Product packed in trays covered in clear plastic, trays packed in cardboard case, 4 trays to a case. 1.4 - Unit Size: 6.75 lb tray 1.5 - Container Description: 12 by 16 inch tray; 1.6 - Total Package Size: 4 trays per… Event 89307 | Name withheld | Food | Class II | 1 |
| 21 Dec 2021 | 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032 | Howmedica Osteonics Corp. | Device | Class II | 2 |
| 21 Dec 2021 | Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083 Event 89270 | Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy | Drug | Class II | 1 |
| 21 Dec 2021 | Beaver Brand Tartar Sauce with Fresh Capers and Dill, 11.5 oz. (326g) jar. UPC 0 71828 00211 8 The label is read in parts: "***BEAVER*** Tartar SAUCE with fresh capers and dill *** INGREDIENTS: SOYBEAN OIL, WATER, CUCUMBERS, EGGS, WHITE DISTILLED VINEGAR, SALT, MUSTARD SEED, LEMON JUICE, HIGH FRUCTOSE CORN SYRUP,… | Beaverton Foods Inc | Food | Class III | 2 |
| 20 Dec 2021 | bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients. | Vyaire Medical | Device | Class I | 1 |
| 20 Dec 2021 | API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either automatically or manually and the… | Biomerieux Inc | Device | Class II | 1 |
| 20 Dec 2021 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03 | American Health Packaging | Drug | Class II | 1 |
| 18 Dec 2021 | "5- Lettuce Mix" (salad product) packed in 6oz. packages | Fresh Express Inc (Div of Chiquita Brands) | Food | Class I | 90 |
| 17 Dec 2021 | Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US | Covidien Llc | Device | Class II | 1 |
| 15 Dec 2021 | CURAD REUSABLE GEL HOT/COLD PACK | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 14 Dec 2021 | Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104 | Smith & Nephew, Inc. | Device | Class II | 1 |
| 14 Dec 2021 | OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall. | Abiomed, Inc. | Device | Class I | 1 |
| 13 Dec 2021 | OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories | Olympus Corporation of the Americas | Device | Class II | 1 |
| 13 Dec 2021 | The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the device, to be used as a guide channel for… Event 89309 | FEMSelect Ltd | Device | Class II | 1 |
| 10 Dec 2021 | THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA Event 89383 | Mallinckrodt Pharmaceuticals Ireland Ltd | Device | Class II | 1 |
| 9 Dec 2021 | The DIXI Medical Microdeep Depth Electrode (“Microdeep Depth Electrode” or “Electrode”) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according… | DIXI MEDICAL USA | Device | Class II | 9 |
| 8 Dec 2021 | R82 by ETAC Push Brace for High-Low | R82 A/S | Device | Class II | 1 |
| 7 Dec 2021 | Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory… | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 6 Dec 2021 | NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes, Manufactured for NaturesPlus 548 Broadhollow Road, Melville, NY 11747, USA Event 89231 | Organics Corporation of America DBA Ambix Laboratories | Drug | Class II | 1 |
| 6 Dec 2021 | ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03 | Edge Pharma, LLC | Drug | Class II | 56 |
| 3 Dec 2021 | CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 Distributed in 12-pk/cases | Dental Alliance Holdings LLC | Drug | Class III | 7 |
| 2 Dec 2021 | Zenition 50, Model #718096 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 3 |
| 2 Dec 2021 | Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter) | LivaNova USA, Inc. | Device | Class II | 1 |
| 1 Dec 2021 | Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box. | CELLTRION USA INC | Device | Class II | 1 |
| 1 Dec 2021 | Premier Rotaclone, Rx only | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 1 Dec 2021 | HARDY DIAGNOSTICS CatScreen, 25dsk/vial | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 17 Nov 2021 | ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 | Luminex Corporation | Device | Class II | 1 |
| 12 Nov 2021 | ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 10 Nov 2021 | PIVO Blood Collection Device 20G, REF: 202-0005 Event 89185 | Name withheld | Device | Class II | 1 |
| 4 Nov 2021 | GE Vscan Extend, being sold as "Vscan Extend Console" | GE Healthcare, LLC | Device | Class II | 7 |
| 12 Oct 2021 | Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000 | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 6 Oct 2021 | Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY | ULTRAtab Laboratories, Inc. | Food | Class II | 9 |
| 2 Aug 2021 | 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL Event 88409 | Je Dois Lavoir LLC | Drug | Class I | 1 |
| 24 Feb 2021 | KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls. | Microbiologics Inc | Device | Class III | 1 |
| 24 Feb 2021 | KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls. | Microbiologics Inc | Device | Class III | 1 |
| 16 Dec 2020 | KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM) | Microbiologics Inc | Device | Class III | 1 |
| 8 Oct 2020 | KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM) | Microbiologics Inc | Device | Class III | 1 |
| 1 Oct 2020 | KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that… | Microbiologics Inc | Device | Class II | 3 |
| 6 Jul 2020 | Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab Event 89336 | Gentueri Inc | Device | Class II | 1 |
| 18 Feb 2020 | 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 | 5 |
| 25 Jun 2019 | MAGEC 1 System | NuVasive Specialized Orthopedics, Inc. | Device | Class II | 1 |
| 2 Mar 2017 | KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation.… | Microbiologics Inc | Device | Class III | 2 |
| 3 Dec 2015 | Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 25 Mar 2013 | KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM) | Microbiologics Inc | Device | Class III | 1 |