| 14 Nov 2022 | Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 | Acella Pharmaceuticals, LLC | Drug | Class III | 2 |
| 10 Nov 2022 | Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01 (91110) | Par Formulations Private Limited | Drug | Class II | 1 |
| 10 Nov 2022 | PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6. | Nephron Sterile Compounding Center LLC | Drug | Class II | 2 |
| 9 Nov 2022 | 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 | ICU Medical Inc | Drug | Class II | 1 |
| 9 Nov 2022 | Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ. (91140) | Individual firm, name withheld | Drug | Class II | 1 |
| 7 Nov 2022 | Wild caught Alaskan Sockeye Smoked Salmon NET WT 4 OZ (113g) EXPIRATION DATE 7-11-2024 UPC: 68826715832 Origin: USA, smoked and cured in The Netherlands | Seven Seas International USA LLC | Food | Class I | 1 |
| 5 Nov 2022 | Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28,… | Adam's Polishes LLC | Drug | Class I | 2 |
| 4 Nov 2022 | The Tomato Head Beet Hummus packaged in 8oz PPE plastic cups - 8 cups per case | Tomato Head Foods | Food | Class II | 2 |
| 3 Nov 2022 | Nash Family Creamery Ranch Cheese Curd packaged in 8oz plastic bag (91128) | Nash Cheese Co LLC | Food | Class II | 1 |
| 31 Oct 2022 | Unity Total Knee System. Used for knee prosthesis in total knee replacement | Corin Ltd | Device | Class II | 1 |
| 31 Oct 2022 | Gem City Fine Foods GF Flourless Chocolate Torte, 4 oz., frozen gluten free dessert, clear plastic package, UPC 855026001018, Gem City Fine Foods, LLC, 3403 S 1400 W, Suite C, W Valley City, UT 84119 | Gem City Fine Foods, LLC | Food | Class II | 1 |
| 28 Oct 2022 | Kalera, The cleanest lettuce in the world., Butter lettuce, Whole head with living roots, Distributed by Kalera, Inc, Orlando FL 32822 | Kalera Public Limited Company | Food | Class I | 3 |
| 27 Oct 2022 | Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO | Southmedic, Inc. | Device | Class II | 1 |
| 27 Oct 2022 | Tiramisu Twist Cookie 3.4 oz. packaged in a gold bag with a large image of two cookies on the package. SKU 4562138450820 3.4 oz. packages, 12 units per case Product of Malaysia | DAISO CALIFORNIA WAREHOUSE | Food | Class I | 1 |
| 27 Oct 2022 | Whole Foods Market Dipping Caramel, PLU 34888 sold by the pound and packaged in nonflexible plastic containers | Whole Foods Market Brand 365, Llc | Food | Class I | 1 |
| 27 Oct 2022 | Gourmet Old-Fashioned Caramel Holiday Popcorn, 18oz box, UPC 25606 00061 (91082) | Individual firm, name withheld | Food | Class II | 1 |
| 27 Oct 2022 | BabyBel Snacker (FG0401 SW Snacker ACABB 5pk) Crunch Pak 5.75 oz In sealed plastic tray, 5 trays per case UPC: 732313001572 Keep refrigerated Crunch Pak Item Number - FG0401 | Taylor Farms Retail, Inc. | Food | Class II | 1 |
| 25 Oct 2022 | 2 oz. units of Pomegranate Fruit Roll Ups in boxes of 24, sold as individual units. Ingredients: Apple, Pomegranate, Water Sugar, Citric Acid, Salt. UPC: 0 84613 13066 8 Product of USA (91050) | Shemshad Food Products, Inc | Food | Class II | 1 |
| 25 Oct 2022 | Food Club Chive Cottage Cheese, 16 oz; Hannaford Chive Cottage Cheese, 16 oz; Hood Chive Cottage Cheese, 16 oz and 24 oz; Price Chopper Chive Cottage Cheese, 16 oz; Market Basket CChive Cottage Cheese, 16 oz | HP Hood LLC | Food | Class II | 13 |
| 24 Oct 2022 | eSuction Small Cavity, Model ET2005 (91074) | Endo-Therapeutics, Inc. | Device | Class II | 1 |
| 24 Oct 2022 | Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001 | Whele LLC DBA Perch | Device | Class I | 3 |
| 24 Oct 2022 | Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle 1000 (91000) | Tollos | Device | Class II | 1 |
| 24 Oct 2022 | Zingerman's Harvest Pumpkin Gelato pint (16oz) and quart (32oz) sizes | Zingerman's Creamery, LLC | Food | Class I | 2 |
| 21 Oct 2022 | Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010 | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 21 Oct 2022 | Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05 | Viatris Inc | Drug | Class II | 1 |
| 20 Oct 2022 | regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit | ROi CPS LLC | Device | Class II | 40 |
| 20 Oct 2022 | NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 | CooperSurgical, Inc. | Device | Class II | 1 |
| 20 Oct 2022 | Umami Everyday Sauce, 5 fl. oz. (148 mL) glass bottle, UPC 8-67732-00032-2, Made for Seed Ranch Flavor Co., LLC, Boulder, CO 80302 Ambient storage - minimum 35 degrees, maximum 85 degrees. | Seed Ranch Flavor Co | Food | Class I | 3 |
| 20 Oct 2022 | Fresh Salmon fillets packed in 10-50 lb. corrugated cardboard or Styrofoam boxes | Mariscos Bahia Inc | Food | Class I | 7 |
| 20 Oct 2022 | Nourish Inc. brand Fruit Snack Pack SNACK ATTACK 6.48 oz. Apples, Medjool Dates, Blackberries, Sunflower Butter Keep refrigerated (91095) | Sodexo, DBA Nourish | Food | Class I | 1 |
| 19 Oct 2022 | Bombolo Biscotti, Assorted Italian Cookies, Net WT. 16 oz (454g) (91046) | Individual firm, name withheld | Food | Class I | 1 |
| 18 Oct 2022 | Hill-Rom Progressa Bed System | Baxter Healthcare Corporation | Device | Class II | 1 |
| 18 Oct 2022 | Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000 | Atrium Medical Corporation | Device | Class II | 1 |
| 18 Oct 2022 | Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India; NDC 62756-970-83 | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 18 Oct 2022 | Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI… | Genentech Inc | Drug | Class III | 1 |
| 18 Oct 2022 | GFUEL brand Watermelon Limeade Energy Drink; 16 fl. oz.; ready-to-drink energy beverage in a can (91107) | G FUEL LLC | Food | Class II | 1 |
| 17 Oct 2022 | 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod) *The part numbers above may be… | Insulet Corporation | Device | Class I | 1 |
| 17 Oct 2022 | GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001 | Steris Corporation | Device | Class II | 1 |
| 17 Oct 2022 | VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012 | Visionsense, Ltd. | Device | Class II | 3 |
| 17 Oct 2022 | Domino and C&H Granulated Pure Cane Sugar Easy Baking Tub packaged in 3.5lb plastic tubs 6 tubs per case | Domino Foods Inc | Food | Class II | 1 |
| 17 Oct 2022 | ReadyMeals Chicken Salad Quad, 12 oz., in a clear plastic container with four compartments, UPC 2 1352 40000 0, Distributed by: Safeway Inc., Pleasanton, CA 94588. Perishable - Keep Refrigerated | Albertsons Companies LLC | Food | Class I | 2 |
| 14 Oct 2022 | Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures. | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 14 Oct 2022 | Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN | Getinge Usa Sales Inc | Device | Class II | 1 |
| 14 Oct 2022 | Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads. | Spectranetics Corporation | Device | Class II | 1 |
| 14 Oct 2022 | GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 | Sonendo Inc | Device | Class II | 2 |
| 14 Oct 2022 | Vegan Drumsticks, 6.6 lb. bags. Ingredients: (NON GMO) Textured Soybean Fiber, Isolated Soy Protein, Soybean Oil, Sugar, Salt, Pepper Spice, Vegan Seasoning Keep Frozen | DA CHENG VEGETARIAN FOOD INC. | Food | Class I | 3 |
| 14 Oct 2022 | La Rosa Brand BluCrab Pasteurized Crabmeat (Jumbo, Lump, Claw) Peso Neto: 454g Can label art is the same for all cans, there is a sticker for each category (Jumbo, Lump, Claw) that goes on the lid. (91048) | RIVER CITY SEAFOOD INTERNATIONAL LLC | Food | Class II | 1 |
| 13 Oct 2022 | BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agents when used with the BD Phoenix Automated Microbiology System. Catalog (Ref) Number: 448607 | Becton Dickinson & Co. | Device | Class II | 1 |
| 13 Oct 2022 | VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative… | Ortho-Clinical Diagnostics, Inc. | Device | Class II | 1 |
| 13 Oct 2022 | EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System. | Boston Scientific Corporation | Device | Class II | 1 |
| 13 Oct 2022 | Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA. (91019) | Individual firm, name withheld | Drug | Class III | 1 |
| 13 Oct 2022 | Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case | Abbott Laboratories | Food | Class II | 12 |
| 13 Oct 2022 | Hammond's Salted Caramel Cookies, NET WT. 5 OZ (142g), UPC 6 91355 89889 5, Manufactured for: Hammond's Candies, 5735 Washington St, Denver, CO 80216. Cookies are packaged in sealed, opaque, white, plastic bag, which is packed inside printed on cardstock box. There are 8 boxes /case. Storage - Ambient. (91009) | Individual firm, name withheld | Food | Class I | 1 |
| 12 Oct 2022 | OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS. (91016) | Novapproach Spine LLC | Device | Class II | 1 |
| 12 Oct 2022 | BASIN SET, MEBS42K, general surgical kit | American Contract Systems, Inc. | Device | Class II | 1 |
| 12 Oct 2022 | Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm | Boston Scientific Neuromodulation Corporation | Device | Class II | 1 |
| 12 Oct 2022 | Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use | Abbott Molecular, Inc. | Device | Class II | 1 |
| 12 Oct 2022 | BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr) | Becton Dickinson Infusion Therapy Systems Inc. | Device | Class II | 1 |
| 10 Oct 2022 | ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device Packaged as follows: UPN: (1)Twin Pack Box 1… | Boston Scientific Corporation | Device | Class II | 3 |
| 10 Oct 2022 | Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs,… | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 10 Oct 2022 | PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml Ampule 1% Lidocaine HCl, 10ml Ampule 0.9% Sodium Chloride, and 5ml Ampule 1.5% Lidocaine HCl with Epinephrine 1:200,000. (91037) | Pajunk Medical Systems, L.P. | Device | Class II | 1 |
| 7 Oct 2022 | FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model Number #0822484/0822483 Note: Transcend Stair Chair Powertraxx (Item #0731403/UDI-DI 00190790004064) not included in this action). | Ferno-Washington Inc | Device | Class II | 1 |
| 7 Oct 2022 | Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, NDC: 67457-246-00 (syringe), 67457-246-01 (carton). | Viatris Inc | Drug | Class I | 1 |
| 7 Oct 2022 | ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Drug | Class II | 32 |
| 6 Oct 2022 | Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP | Edwards Lifesciences, LLC | Device | Class II | 2 |
| 6 Oct 2022 | 3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape | 3M Healthcare Business | Device | Class II | 18 |
| 6 Oct 2022 | Craftology This Is My Happy Place Handcrafted Pasta Salad 14oz clear plastic clamshell, UPC 8 55034 00649 4, 6 units per wholesale case. Dutch Treat Foods Sweet Pea Pasta Salad 10 pound case (2, 5 pound plastic bags per case), 20 pound and 30 pound buckets (90988) | Craftology, LLC DBA Dutch Treat Foods | Food | Class II | 1 |
| 6 Oct 2022 | H-E-B Meal Simple Tomato Basil Soup 32 oz. Plastic containers, 6 containers per case Keep Refrigerated. (90961) | Bakkavor USA, Inc | Food | Class I | 1 |
| 6 Oct 2022 | Earth Grown Vegan Traditional Falafel NET WT 12 OZ (340g), 12 pieces UPC:4 0991002 24337 | Cuisine Innovations Unlimited, LLC | Food | Class I | 2 |
| 5 Oct 2022 | Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90 | Aurobindo Pharma USA Inc. | Drug | Class II | 1 |
| 5 Oct 2022 | Caribou Coffee Snack Fruit and Cheese Plate, item # 3818, Net Wt 6.2 oz. (176g) 3 cheeses, red grapes, apples, rosemary crackers. Keep Refrigerated. Manufactured By: Cut Fruit Express, Inver Grove Heights, MN | Cut Fruit Express, Inc. | Food | Class I | 1 |
| 4 Oct 2022 | NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis. | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 4 Oct 2022 | EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing. (91002) | Altimate Medical, Inc. | Device | Class II | 1 |
| 4 Oct 2022 | 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1 | Exela Pharma Sciences LLC | Drug | Class I | 2 |
| 3 Oct 2022 | Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830 (90968) | Rebiscan, Inc. | Device | Class II | 1 |
| 3 Oct 2022 | MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280 | Beckman Coulter, Inc. | Device | Class II | 1 |
| 3 Oct 2022 | BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader. | Becton, Dickinson and Company, BD Biosciences | Device | Class II | 3 |
| 3 Oct 2022 | JLM Sesame Sticks Mix in clear plastic 11oz. tub UPC 094776081646 12 retail units per case | JLM Manufacturing LLC | Food | Class II | 2 |
| 3 Oct 2022 | BRIE EN CROUTE WITH RASPBERRY (90951) | Kabobs Acquisition Inc. | Food | Class II | 1 |
| 3 Oct 2022 | Pad Thai Noodles Rama Foods (Brand) Net Wt.: 16 oz (1 LB) LDPE (Vacuum sealed package) 30 Pkgs./Per case Keep Refrigerated Mfg. date: 09/26/22 (90963) | Rama Food Manufacture Corp | Food | Class II | 1 |
| 30 Sep 2022 | Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3 | Wright Medical Technology, Inc. | Device | Class II | 2 |
| 30 Sep 2022 | TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F.. | LeMaitre Vascular, Inc. | Device | Class II | 1 |
| 30 Sep 2022 | EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile. | Boston Scientific Corporation | Device | Class II | 2 |
| 30 Sep 2022 | Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193, P7900B100195, P7900B100230, P7900B100236, P7900B100239, P7900B100244, P7900B100256, P7900B100257, P7900B100259, P7900B100264, P7900B100268, P7900B100269, P7900B100292, P7900B100296, P7900B100302,… | Baxter Healthcare Corporation | Device | Class I | 5 |
| 30 Sep 2022 | BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures. | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 13 |
| 30 Sep 2022 | Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, ankle, hand, knee, hip or spine surgery). Catalog#: 376780 | Beaver Visitec International, Inc. | Device | Class II | 1 |
| 30 Sep 2022 | Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01 | VistaPharm, Inc. | Drug | Class II | 1 |
| 30 Sep 2022 | Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe) | AuroMedics Pharma LLC | Drug | Class II | 1 |
| 30 Sep 2022 | Saint Louis Domestic Brie Wedge, 7oz, saran wrapped, UPC: 041563 263709; Saint Louis Domestic Cut Brie Wedge, variable weight-6lb RD WT, saran wrapped, UPC: 041563 370018; Saint Louis Brie, variable weight, saran wrapped, UPC: 21107100000; Saint Louis CW Brie Wheel, 1/3 KG RD WT, saran wrapped, UPC: 00021171800000;… (90952) | Swiss American Inc | Food | Class I | 1 |
| 30 Sep 2022 | Zerto Fontal Cheese UPC 20565300000 sliced in store and sold by the pound wrapped in plastic wrap | Whole Foods Market Brand 365, Llc | Food | Class I | 1 |
| 29 Sep 2022 | Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450 | Canon Medical System, USA, INC. | Device | Class II | 1 |
| 29 Sep 2022 | Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-027-10 | Golden State Medical Supply Inc. | Drug | Class I | 1 |
| 28 Sep 2022 | Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system (90954) | iRhythm Technologies, Inc. | Device | Class II | 1 |
| 28 Sep 2022 | K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 (91030) | Kamiya Biomedical Company, LLC | Device | Class II | 1 |
| 28 Sep 2022 | Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115 | Cardinal Health 200, LLC | Device | Class II | 8 |
| 28 Sep 2022 | X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673 | X-NAV Technologies, LLC | Device | Class II | 1 |
| 28 Sep 2022 | Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device. | Covidien, LP | Device | Class II | 2 |
| 28 Sep 2022 | Diana s Milk Chocolate Banana Babies UPC: 7-43490-00010-4 10.5-ounce 5 count packages (90936) | Diana's Bananas, Inc. | Food | Class I | 1 |
| 28 Sep 2022 | TASTE OF INSPIRATION 8 oz Brie - w/Herb center layer, rounds UPC 725439802567 | Old Europe Cheese, Inc. | Food | Class I | 10 |
| 26 Sep 2022 | CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST | Carefusion 2200 Inc | Device | Class II | 17 |
| 23 Sep 2022 | LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with… | LumiraDx | Device | Class III | 1 |
| 23 Sep 2022 | THE CHAI BOX CHAI CONCENTRATE 16FL OZ/473ML glass bottles UPC 7 93611 81925 2 REGRIGERATE AFTER OPENING. USE WITHIN 14 DAYS and 64FL OZ/1892ML plastic bottles KEEP REFRIGERATED USE WITHIN 7 DAYS OF OPENING UPC 7 93611 81926 9. INGREDIENTS Water, Black Teas, Spices - Cardamom, Cinnamon, Fennel, Cloves, Ginger, and Raw… | The Chai Box | Food | Class III | 2 |
| 22 Sep 2022 | Hamilton-C6 | Hamilton Medical AG | Device | Class II | 1 |
| 22 Sep 2022 | AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR | ZOLL Circulation, Inc. | Device | Class II | 1 |
| 21 Sep 2022 | GORE CARDIOFORM ASD Occluder. cardiovascular implant. | W L Gore & Associates, Inc. | Device | Class II | 1 |
| 21 Sep 2022 | WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System. | MICROVENTION INC. | Device | Class II | 1 |
| 20 Sep 2022 | Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table | Baxter Healthcare Corporation | Device | Class II | 6 |
| 20 Sep 2022 | STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12 | Ethicon, Inc. | Device | Class II | 1 |
| 20 Sep 2022 | Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling UPN: H787MPP5SAT0 Catalog… | Angiodynamics, Inc. | Device | Class II | 1 |
| 20 Sep 2022 | ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 20 Sep 2022 | Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter. | TELEFLEX LLC | Device | Class II | 1 |
| 20 Sep 2022 | Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742 | Individual firm, name withheld | Device | Class II | 2 |
| 20 Sep 2022 | da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS) | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 19 Sep 2022 | 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB | DeVilbiss Healthcare LLC | Device | Class II | 1 |
| 19 Sep 2022 | Amla Alcohol-Free Extract, 2 oz. glass bottle, UPC 041979376093 and Amla Alcohol-Free Extract, 4 oz. glass bottle, UPC 041979376116, Secrets of the Tribe LLC, PO Box 5264, Denver, CO, 80217 | Secrets Of The Tribe | Food | Class II | 2 |
| 15 Sep 2022 | B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022) | Medical Action Industries, Inc. 306 | Device | Class II | 1 |
| 14 Sep 2022 | Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15¿ TC11050 00840180510810 CI-11050-09102515 Longer IdentiTi PO Trial Tip, 12A X 9P X 10 X 25mm, 15¿ TC11050 00840180510827 CI-11050-10102515 Longer IdentiTi PO Trial Tip, 13A X 10P… | Alphatec Spine, Inc. | Device | Class II | 1 |
| 14 Sep 2022 | ARIES SARS-CoV-2 Assay, REF: 50-10047 | Luminex Corporation | Device | Class II | 1 |
| 14 Sep 2022 | Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessory | Avanos Medical, Inc. | Device | Class II | 1 |
| 9 Sep 2022 | MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245 | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 5 |
| 7 Sep 2022 | THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation. | Johnson & Johnson Surgical Vision, Inc. | Device | Class II | 1 |
| 1 Sep 2022 | Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B (90833) | Texas Medical Technology Inc. | Device | Class II | 1 |
| 22 Aug 2022 | sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring. | SenTec AG | Device | Class II | 1 |
| 19 Aug 2022 | MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001 | Canadian Hospital Specialties | Device | Class III | 1 |
| 16 Aug 2022 | ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure. | ConvaTec, Inc | Device | Class II | 4 |
| 15 Aug 2022 | Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active… | Ultra Chem Labs Corp | Drug | Class II | 2 |
| 12 Aug 2022 | Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500 | SEDECAL SA | Device | Class II | 1 |
| 12 Aug 2022 | EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component. | Encore Medical, LP | Device | Class II | 2 |
| 5 Aug 2022 | LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter. | Datascope Corporation | Device | Class II | 1 |
| 3 Aug 2022 | CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B, CORA1825S/A, CORA2010/A, CORA2010/B, CORA2010S/A, CORA2015/A, CORA2015/B, CORA2015S/A,… | Merit Medical Systems, Inc. | Device | Class II | 2 |
| 25 Jul 2022 | Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate), Rx Only, distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, manufactured by: Sun… | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 18 Jul 2022 | Bella Cucina Artful Food Artichoke Lemon Pesto Net Wt. 3.5 oz (100g) UPC 6 19193 00232 8, Net Wt. 17 oz (xxxg) UPC 6 19193 00132 1 & Net Wt. 23 oz (652g) UPC 6 1913 00130 7 in glass jar, Manufactured by Bella Cucina Artful Food Atlanta, GA 30310 | Bella Brands, LLC DBA Bella Cucina Artful Food | Food | Class II | 14 |
| 9 Jun 2022 | Qassim Mix for Coffee, Net Weight 125g, packaged in a plastic container (UPC 6-281103 300011). Each case contains 48-125g containers. (90465) | Tomoorona LLC | Food | Class II | 1 |
| 20 Jul 2021 | CritiCool, thermoregulation device (90939) | Belmont Instrument Corporation | Device | Class II | 1 |
| 24 Feb 2021 | Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter | Access Vascular, Inc. | Device | Class II | 1 |
| 19 Jan 2018 | InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC (91083) | Allison Medical, Inc. | Device | Class II | 1 |