| 17 Apr 2025 | WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. | Straumann USA LLC | Device | Class II | 1 |
| 16 Apr 2025 | Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)] | Remote Diagnostic Technologies Ltd. | Device | Class II | 1 |
| 15 Apr 2025 | HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01. | OurPharma LLC | Drug | Class III | 1 |
| 15 Apr 2025 | DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15 | Pharmadel, LLC | Drug | Class II | 6 |
| 14 Apr 2025 | Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10 | Breckenridge Pharmaceutical, Inc | Drug | Class II | 2 |
| 14 Apr 2025 | ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61 | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Drug | Class II | 1 |
| 13 Apr 2025 | MAGIC FLAME, HULLED SUNFLOWER KERNELS, BAKERY GRADE, 501b. Bag, Three ply Paper bags, 1100 Paper bags x 50 Ib. on 20 pallets. Store in dry warehouse, room temperature (96708) | JJ Nuts, LLC | Food | Class II | 1 |
| 10 Apr 2025 | Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01 | Eugia US LLC | Drug | Class II | 1 |
| 10 Apr 2025 | clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 10 Apr 2025 | MO-CHA brand Premium Non-Dairy Creamer; INGREDIENTS Glucose syrup, Refined vegetable oil, Whey powder, Sugar, Casein, Emulsifier (471, 481i), Stabilizer(340ii, 452i), Anti-caking agent(551), Food flavor; Shelf Life: 24 months; Net Weight (NET WT): 2.2 lbs (1kg); IMPORTED BY Momo Tea Inc.; PRODUCT OF CHINA (96675) | MOMO TEA INC | Food | Class I | 1 |
| 9 Apr 2025 | Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318 | Apipharma | Drug | Class II | 2 |
| 4 Apr 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard… | Micro-X Ltd. | Device | Class II | 2 |
| 4 Apr 2025 | Texas Olive Co. Pepperoncini 16 oz glass jars | All American Trading Of Houston, Inc. | Food | Class II | 3 |
| 4 Apr 2025 | Marketside brand celery stick. Net wt. 1.6 OZ. (45g); Rear panel: 1 serving per container; Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 UPC# 6 81131 16151 0 (96654) | Duda Farm Fresh Foods, Inc. | Food | Class I | 1 |
| 4 Apr 2025 | Spermidine, Maximum Strength, 10 mg per serving, Support healthy Aging, Dietary Supplement, 120 Capsules, oral consumption, shelf life: 24 months, PETE/White/150cc Plastic bottle/lid, 120 count.Supplement Facts: Spermidine 3HCL 10mg*** Other Ingredients: Hydroxypropyl Methylcellulose, Rice Flour (96657) | Supplement Manufacturing Partner Inc. | Food | Class I | 1 |
| 4 Apr 2025 | Moroccan Style Lentil Soup, 4 x 8lb pouches, Net wt. 32lb | Request Foods Incorporated | Food | Class II | 4 |
| 3 Apr 2025 | MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; | Globus Medical, Inc. | Device | Class II | 1 |
| 3 Apr 2025 | chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1 | Zydus Pharmaceuticals (USA) Inc | Drug | Class II | 1 |
| 3 Apr 2025 | Label: IQF CILANTRO LARGE; NET WT: 30LB; PERISHABLE KEEP FROZEN; Packaging: blue plastic liner inside brown cardboard box | Supherb Farms | Food | Class II | 2 |
| 2 Apr 2025 | Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41. | Amerisource Health Services LLC | Drug | Class II | 3 |
| 1 Apr 2025 | Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System. | Philips North America Llc | Device | Class II | 1 |
| 1 Apr 2025 | Tony's Chocolonely Everything Bar | TONY'S CHOCOLONELY INC | Food | Class II | 2 |
| 1 Apr 2025 | PANADERIA/BAKERY Salvadorena; Quesadilla de Queso; Ingredients: Rice, Wheat Flour, soy, eggs, sugar, butter, baking powder, salt, water, sour cream, sesame seeds; UPC 0 21651 16499 6; NET WEIGHT APPROX 14 OZ (96614) | Individual firm, name withheld | Food | Class II | 1 |
| 1 Apr 2025 | Dr. Praeger s California Veggie Fries 8oz, (96623) | Individual firm, name withheld | Food | Class II | 1 |
| 31 Mar 2025 | 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10 | B. Braun Medical Inc | Drug | Class II | 1 |
| 31 Mar 2025 | Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY | Medisca Inc. | Drug | Class II | 1 |
| 31 Mar 2025 | Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11 | Denver Solutions, LLC DBA Leiters Health | Drug | Class II | 5 |
| 29 Mar 2025 | Trader Joe's Hot Honey Mustard Dressing (SKU #80152), packaged in glass bottle with tamper overwrap on plastic cap, net wt. 12 fl. oz. UPC 0080 1522. DIST. & SOLD Exclusively by: Trader Joe's Monrovia, CA. These 12oz. bottles were sold directly to consumers. The master cases were correctly labeled as Thai Style… | Reser's Fine Foods, Inc. | Food | Class I | 1 |
| 28 Mar 2025 | Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S; | Stryker GmbH | Device | Class II | 2 |
| 28 Mar 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray… | Micro-X Ltd. | Device | Class II | 2 |
| 28 Mar 2025 | Walker's Wine Juice Pumpkin Juice 2.5, 5, 30, 60, 275 gallon bulk containers (96609) | Walker's Fruit Basket and Press House | Food | Class I | 1 |
| 27 Mar 2025 | Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount (96581) | IHB OPERATIONS B.V. | Device | Class II | 1 |
| 27 Mar 2025 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer | Beckman Coulter, Inc. | Device | Class II | 1 |
| 27 Mar 2025 | CFS CROMER FOOD SERVICES, INC. Anderson, SC 29621 CHICKEN SALAD On White NET WT. 4.3 OZ CONTAINS: EGGS, WHEAT, SOY UPC 31166 & UPC 13172 (96568) | Cromer Food Services, Inc | Food | Class I | 1 |
| 27 Mar 2025 | 5000108 OATMEAL RAISIN COOKIE DOUGH, 6 poly bags of 30 frozen pucks in a corrugate case, Net Weight: 8.67 kg (19.12 lb) | Craftmark Bakery, LLC | Food | Class II | 3 |
| 26 Mar 2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10. | Breckenridge Pharmaceutical, Inc. | Drug | Class II | 1 |
| 26 Mar 2025 | Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2 (96552) | Chattem Inc | Drug | Class II | 1 |
| 26 Mar 2025 | Desert Farms Jalapeno Mustard. Caution to refrigerate after opening. The shelf life is 2 years after the date of manufacture. It is packaged in 8 oz glass jars with a net wt. of 8.8 oz (249g). UPC code 05423401721, The Truck Farm, LLC 645 S. Alameda Las Cruces, NM, 88005. (96584) | The Truck Farm, LLC | Food | Class II | 1 |
| 26 Mar 2025 | Cabot Creamery 8oz Extra Creamy Premium Butter, Sea Salted. Packaged as (2) 4oz sticks in cardboard shells; UPC: 0 78354 62038 0 (96592) | AGRI-MARK INC | Food | Class III | 1 |
| 26 Mar 2025 | Tostitos Cantina Traditional Yellow Corn Tortilla Chips. Net Wt. 13oz. (368.5) UPC 0 28400-52848 1. Frito-Lay, Inc., Plano, TX 75024-4099. | Frito-Lay, Inc. Headquarters | Food | Class I | 1 |
| 25 Mar 2025 | restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System | Conformis Inc. | Device | Class II | 1 |
| 25 Mar 2025 | Lillie's Q Buffalo Wing Sauce. Net wt. 13.5 oz, UPC 810069510972, Case label: Lillie's Q Buffalo Wing Sauce, Item # FGLOL422 Lot # 002125, 6/13.5 oz, UPC 10810069510979, BEST BY: JAN/21/2026 (96602) | OLD WORLD SPICES & SEASONING, INC | Food | Class II | 1 |
| 25 Mar 2025 | Kashk (Whey) Ingredients: Whey, Water, Salt Nader Trading Inc., 1821 E. Dryer Road, Santa Ana, CA 92705 UPC# 685357001537 (96575) | Nader Trading, Inc. | Food | Class II | 1 |
| 25 Mar 2025 | MTN OPS MULTI-V Men's Daily Multivitamin dietary supplement, 60 Capsule Bottle (30 Serving). Manufactured exclusively for MTN OPS, LLC, 251 S Mountain Rd., Fruit Heights, UT. UPC 8 40359 40458 2 (96578) | MTN OPS, LLC | Food | Class II | 1 |
| 25 Mar 2025 | Falafel King Taste the Mediterranean is a multi-component, 4 section plastic container, that includes Traditional Hummus, Falafel Balls, Tzatziki, and Mixed Vegetables. " Net Wt: 13 oz. UPC 82298621035 4. The Traditional Hummus is the recalled product and the ingredient statement declares freshly cooked garbanzo… (96576) | Falafel King Enterprises, Inc. | Food | Class II | 1 |
| 24 Mar 2025 | Welch Allyn Connex Vital Signs Monitor (CVSM): | Baxter Healthcare Corporation | Device | Class II | 3 |
| 24 Mar 2025 | Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented | Zimmer, Inc. | Device | Class II | 5 |
| 24 Mar 2025 | Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11. | Amerisource Health Services LLC | Drug | Class II | 1 |
| 24 Mar 2025 | Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00 | RemedyRepack Inc. | Drug | Class II | 1 |
| 22 Mar 2025 | CACAO BARRY Gianduja Noir, 5.5lbs (2.5kg) plastic bucket, 8 buckets per case. (96572) | Barry Callebaut USA LLC | Food | Class II | 1 |
| 21 Mar 2025 | Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings. | Radiometer Medical ApS | Device | Class II | 1 |
| 21 Mar 2025 | Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; 4) 84MTVE2-US; 5) 84MTVEC-6; 6) 84MTVEC-B; 7) 84MTVEP-B; 8) 84MTVEX-4; 9) 84MTVX2-4; 10) 84MTVX2-6; 11) 84MTVX2-B; 12) 84MTVX2-US; 13) 84MTVXC-4; 14) 84MTVXC-B; 15) 84MTVXP-2; 16) 84MTVXP-4; 17) 84MTVXP-B;… | Baxter Healthcare Corporation | Device | Class II | 7 |
| 21 Mar 2025 | Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01. | Zydus Pharmaceuticals (USA) Inc | Drug | Class II | 1 |
| 21 Mar 2025 | Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton) | Somerset Therapeutics Private Limited | Drug | Class II | 5 |
| 21 Mar 2025 | Fresh Flax Oil OMEGA 3-6-9 Organic Flaxseed Oil 16 Fl oz / 473 ml, Dietary Supplement, Black HDPE plastic bottle with cap, Manufactured for Natural Slim, San Juan Puerto Rico (96562) | Bioriginal Food & Science Corporation | Food | Class II | 1 |
| 20 Mar 2025 | The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula has four lumens which house the endoscope, C-Ring, distal lens washer tube, and Harvesting Tool for cutting and cauterizing vessel branches. The Harvesting Tool… | Maquet Cardiovascular, LLC | Device | Class II | 1 |
| 20 Mar 2025 | Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to reduce future menstrual bleeding. The… (96485) | Channel Medsystems, Inc. | Device | Class II | 1 |
| 20 Mar 2025 | GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A). | Agilent Technologies, Inc. | Device | Class II | 1 |
| 20 Mar 2025 | The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished). | Abbott Molecular, Inc. | Device | Class II | 1 |
| 19 Mar 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter Component: No | Avanos Medical, Inc. | Device | Class I | 8 |
| 19 Mar 2025 | Brioche Bread Loaf and Hamburger buns packaged in brown box and labeled as follows: 1. Ben E. Keith Co. Dense Brioche Pullman Loaf, 33 oz. 7 Count, Case Wt. 15 lbs. Product Code: 654203. The Bakery Group, 9106 Sovereign Row, Dallas, TX 75247. GTIN: 00038597654203 2. Ben E. Keith Co. 4.5" Brioche HB Buns. 3oz. 48… (96579) | Harvey Investments LLC / The Baking Group | Food | Class II | 1 |
| 19 Mar 2025 | Turkey BLT on Sourdough Net Wt. 8.94 OZ (253g) in plastic clamshell | The Coastal Companies DBA Hearn Kirkwood | Food | Class II | 1 |
| 19 Mar 2025 | favorite day gourmet New York-Style CHEESECAKE 2 SLICES NET WT 6OZ (170 g) UPC 0 85239 09690 1 Target Brands, Inc. (96529) | Dessert Holdings Llc | Food | Class II | 1 |
| 18 Mar 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No | Abbott Laboratories | Device | Class II | 5 |
| 18 Mar 2025 | Apple Juice; clear/translucent bulbous/round glass bottle with white metal screw top lid; (4 - 10 oz bottles per pack; 6 packs per case) | S Martinelli & Company | Food | Class II | 1 |
| 18 Mar 2025 | Arepas de Chocolo, Abuelas Food Company, Delicias de la Abuela's, Net Weight: 22.5oz. (638g), 5 units per package, Vacuum seal packages and twist tie bags, KEEP REFRIGERATED. UPC 850283002037 (96563) | DELICIAS DE LA ABUELA INC | Food | Class II | 1 |
| 17 Mar 2025 | Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080 | Abbott | Device | Class II | 2 |
| 17 Mar 2025 | Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13 (96496) | BIOCON PHARMA INC | Drug | Class II | 1 |
| 17 Mar 2025 | Dried Cranberries (21.75 lb/case; 300 - 1.16 oz packages/case) (96530) | Victor Packing Inc. | Food | Class II | 1 |
| 17 Mar 2025 | Teriyaki Sauce, Red Shell branded. Ingredients: Soy sauce(water, soybeans, wheat, salt, sodium benzoate), water, sugar, cooking wine( water, rice, malt), sweet cooking wine(corn syrup, rice, water, malt), modified food starch, dried onion, dried ginger root, dried garlic, lactic acid, spices. "Shake well before use.… (96540) | Red Shell Foods, Inc. | Food | Class II | 1 |
| 17 Mar 2025 | Lean Cuisine Lemon Garlic Shrimp Stir Fry, NET WT 10 OZ (283g), in a plastic tray with film seal, packaged inside a paperboard carton; 10 consumer units per case | Nestle-USA, Inc. (Corporate Office) | Food | Class II | 3 |
| 17 Mar 2025 | GOLD GARLIC POWDER IRRADIATED; NET WT. 50 LBS; PRODUCT OF CHINA (96641) | Pacific Meridian Group, LLC | Food | Class II | 1 |
| 14 Mar 2025 | Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly | Merit Medical Systems, Inc. | Device | Class II | 2 |
| 14 Mar 2025 | Jinga Glass Noodles with vegetables 8 oz. and 12 oz. (96503) | HAR Maspeth Corp. | Food | Class I | 1 |
| 13 Mar 2025 | HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System. | Thoratec LLC | Device | Class I | 1 |
| 13 Mar 2025 | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52 (96470) | Individual firm, name withheld | Drug | Class I | 1 |
| 13 Mar 2025 | Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-580-01 | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 39 |
| 13 Mar 2025 | Tortilla Chip Green 4 cut packed 5lbs per bag; 6 bags per box (96524) | La Mexicana Tortilla Factory, Inc. | Food | Class II | 1 |
| 13 Mar 2025 | COFFEE ROASTERS Our Family TRAVERSE CITY CHERRY ARTIFICIALLY FLAVORED DECAF LIGHT ROAST GROUND COFFEE NET WT 12 OZ (340g) UPC 0 70253 11080 1 DISTRIBUTED BY THE SPARTANNASH COMPANY GRAND RAPIDS, MI 49518 (96499) | Massimo Zanetti Beverage USA | Food | Class II | 1 |
| 13 Mar 2025 | SeaBear Smokedhouse Salmon Chowder is packaged in flexible retort pouch, net wt. 12-oz., UPC 0 34507 07001 3. Case label: Item 60077 Salmon Chowder 12/12oz, SeaBear/G&D Anacortes, WA. | Seabear Company | Food | Class II | 2 |
| 12 Mar 2025 | Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a | Qiagen Sciences LLC | Device | Class II | 1 |
| 12 Mar 2025 | Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is intended for single use only. Component: Not… | Draeger, Inc. | Device | Class I | 7 |
| 12 Mar 2025 | Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and… (96444) | Conavi Medical Inc. | Device | Class I | 1 |
| 12 Mar 2025 | Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, CA 90401, Made in the USA, UPC 7 35786 01921 1, UPC 8 42944 10223 1, and also packaged as a twin pack UPC 8 42944 10241 5, | Alchemee, LLC | Drug | Class II | 2 |
| 12 Mar 2025 | Julie's Gorditas De Nata; Ingredients: Flour, Vegetable Oil, Sugar, Baking Soda, Milk, Sour Cream, Butter, Cream Of Milk, Cinnamon, Vanilla; Net Wt. 16.75 OZ UPC# 0 00202 12018 6 (96502) | Individual firm, name withheld | Food | Class II | 1 |
| 12 Mar 2025 | Good & Gather baby Pea, Zucchini, Kale & Thyme Vegetable Puree. Net Wt 4 oz. (113g). 6+ months. UPC 1 91907-99314 1. Distributed by Target Corporation, Minneapolis, MN 55403. Product of Colombia (96501) | FRUSELVA USA | Food | Class II | 1 |
| 11 Mar 2025 | BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000757, CK001042, 9174108, 1174108D1,… | Bard Access Systems, Inc. | Device | Class I | 1 |
| 11 Mar 2025 | Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 11 Mar 2025 | BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; MINI 2HH-1FH, 169-106; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM, 169-107; MINI 2HH-1FM, 138906-01; MINI 3HH-1FG, 169-110; MINI… | CareFusion 303, Inc. | Device | Class II | 1 |
| 11 Mar 2025 | BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings. | CareFusion 303, Inc. | Device | Class II | 1 |
| 11 Mar 2025 | BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 155143-01 BD PYXIS MEDBANK TWR MN CR-14HH-P / 155144-01 BD… | CareFusion 303, Inc. | Device | Class II | 1 |
| 11 Mar 2025 | chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01 | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 11 Mar 2025 | Farmer House Preserve Olive Strips (96504) | Lins Waha International Corp | Food | Class III | 1 |
| 11 Mar 2025 | 365 Whole Foods Market Small Bites Macaroni & Cheese. Net Wt 8.5 oz (240g) Keep Frozen. UPC 99482499709. Distributed by: Whole Foods Market, Austin, TX (96513) | C.H. Guenther & Son LLC | Food | Class I | 1 |
| 10 Mar 2025 | Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2). | Maquet Cardiovascular, LLC | Device | Class II | 1 |
| 10 Mar 2025 | NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154… | Medtronic Xomed, Inc. | Device | Class II | 1 |
| 10 Mar 2025 | Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System. | Philips North America Llc | Device | Class II | 2 |
| 10 Mar 2025 | Omni-Macs McDonagh Medical Center Dietary Supplement 100 CAPSULES, Suggested Use: 1-3 capsules per day with meals, Distributed by: McDonagh Medical Center Gladstone, MO 64119 (96473) | Veridance Pharmacal, LLC | Food | Class II | 1 |
| 10 Mar 2025 | Zaarah Herbals brand Bhringraj Powder; packaged in 100g clear jars with gold lids; UPC: 6 35028 99973 1 | NEW YORK WHOLESALE GROUP | Food | Class I | 4 |
| 8 Mar 2025 | TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002; | Straumann USA LLC | Device | Class II | 1 |
| 7 Mar 2025 | PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP | Ethicon Endo Surgery, LLC | Device | Class II | 4 |
| 7 Mar 2025 | [CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL] Isopropyl alcohol 91%, Dist. by: Amazon.com Services, LLC, Seattle, WA 98109. | Consumer Product Partners, LLC | Drug | Class II | 1 |
| 7 Mar 2025 | Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an affiliate of Gilead Sciences, Inc., Foster City, CA 94404, Made in Ireland, NDC# 72626-2701-1 (96434) | ASEGUA THERAPEUTICS LLC | Drug | Class II | 1 |
| 7 Mar 2025 | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4 | Exela Pharma Sciences LLC | Drug | Class II | 1 |
| 6 Mar 2025 | Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H45113VGSU), R3 PeriOP for China (Model Number H45113VGPO), R3 Expert for China (Model Number H45113VGEX ), R3 Pro for China (Model Number… | GE Medical Systems, LLC | Device | Class II | 2 |
| 6 Mar 2025 | Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays. | Fisher Diagnostics | Device | Class II | 2 |
| 6 Mar 2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75 | QuVa Pharma, Inc. | Drug | Class II | 3 |
| 6 Mar 2025 | Coco-Cola Original Taste, 12 Fl Oz. (355mL). Can UPC 0 49000-00634 6. 12-can pack UPC 0 49000-02890 4. Canned Under Authority of the Coca-Cola Company, Atlanta, GA 30313. (96489) | Great Lakes Coca-Cola Distribution LLC | Food | Class II | 1 |
| 5 Mar 2025 | stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty | Individual firm, name withheld | Device | Class II | 9 |
| 5 Mar 2025 | MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720R | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 4 |
| 5 Mar 2025 | Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02 | Strides Pharma, Inc. | Drug | Class II | 2 |
| 5 Mar 2025 | Golden Crop Candy (10 oz. (283g) wrapped candies) | Blooming Import Inc. | Food | Class II | 2 |
| 4 Mar 2025 | Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No | Abbott Diagnostics Scarborough, Inc. | Device | Class II | 3 |
| 4 Mar 2025 | Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No | Abbott Diagnostics Scarborough, Inc. | Device | Class II | 3 |
| 4 Mar 2025 | Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators (96445) | Individual firm, name withheld | Device | Class II | 1 |
| 4 Mar 2025 | Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only | Cordis US Corp | Device | Class II | 2 |
| 4 Mar 2025 | InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA | Medtronic MiniMed, Inc. | Device | Class II | 1 |
| 4 Mar 2025 | Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the… | ZOLL Circulation, Inc. | Device | Class I | 1 |
| 4 Mar 2025 | Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class III | 2 |
| 4 Mar 2025 | Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Drug | Class III | 1 |
| 4 Mar 2025 | Wangzhine branded Hot Pot Sauce; Net Weight: 160 Grams, 5.64OZ; 36 units/case; UPC# 6907592001375 | Liaoning Cheng Da (USA) Inc | Food | Class I | 2 |
| 4 Mar 2025 | BaiWei ShanZhuang, Dried Seedless Plum Candy, 9.16 oz. (260g), plastic bags, 30 bags per case. | Tristar Food Wholesale Co Inc | Food | Class III | 1 |
| 4 Mar 2025 | Panang Curry Tofu Vegan GF is a refrigerated and ready to eat product, packaged in plastic box, net wt. 13.5oz. UPC 88581 149928. Label declares ingredients as Tofu, Panang Curry Paste, Carrots and Peas, Coconut Milk, Kaffir Lime Leaves. (96438) | Seattle Homemade Thai LLC | Food | Class II | 1 |
| 3 Mar 2025 | Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS | Baxter Healthcare Corporation | Device | Class II | 1 |
| 3 Mar 2025 | Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754 | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 3 Mar 2025 | stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented | Tornier, Inc | Device | Class II | 1 |
| 3 Mar 2025 | Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395; | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 34 |
| 3 Mar 2025 | DRIED LILY FLOWERS Net Weight 2.5 oz (70g) Ingredients: Lily flower (Hemerocallis citrina) Distributed by: U.S. TRADING COMPANY Hayward, CA 94545-1130 Product of China (96383) | U.S. Tov, Inc. dba U.S. Trading Company | Food | Class III | 1 |
| 28 Feb 2025 | Phoroptor VRx Digital Refraction System Model Numbers: 16241 | Reichert, Inc. | Device | Class II | 2 |
| 28 Feb 2025 | Monterey AL Implant Inserter; 10/12mm; Catalog 48019100. | Individual firm, name withheld | Device | Class II | 4 |
| 27 Feb 2025 | Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voyant 1-Day Premium Toric. Brand Names (OUS only): CADENCE DELUXE 1-DAY TORIC, DUBLAN PREMIUM OXYGEN 1 DAY TORIC, EV… | CooperVision, Inc. | Device | Class II | 1 |
| 27 Feb 2025 | Premier Solo Diamond - Large Invented Cone; SKU: 807016C. (96394) | Premier Dental Products Co | Device | Class II | 1 |
| 27 Feb 2025 | NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10 | Zimmer, Inc. | Device | Class II | 1 |
| 27 Feb 2025 | FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 27 Feb 2025 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | Device | Class I | 2 |
| 26 Feb 2025 | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R | Covidien | Device | Class I | 1 |
| 26 Feb 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control… | Beckman Coulter Inc. | Device | Class II | 1 |
| 26 Feb 2025 | Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95 (96492) | Qapel Medical Inc. | Device | Class I | 1 |
| 26 Feb 2025 | Flor de Michoacan Blue Hawaiian Artificially Flavored Beverage Concentrate. 1 Gallon (3.78L) Pasteurized. Keep Frozen. UPC 1 80596-00039 1. Processed for: Paletas Ice Cream, El Paso, Texas 79907 (96402) | Paletas Ice Cream, LLC | Food | Class III | 1 |
| 25 Feb 2025 | Baxter Operating table column TS7500 MOBIUS, Product Code 1704695 | Baxter Healthcare Corporation | Device | Class II | 14 |
| 25 Feb 2025 | Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S. | Baxter Healthcare Corporation | Device | Class II | 1 |
| 25 Feb 2025 | Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL | Stryker Corporation | Device | Class II | 14 |
| 25 Feb 2025 | Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices. | Philips North America Llc | Device | Class II | 3 |
| 25 Feb 2025 | METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3. | A-S Medication Solutions LLC | Drug | Class II | 1 |
| 24 Feb 2025 | Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF# 9524 (Small) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing stimulus to a targeted nerve. The… | Checkpoint Surgical Inc | Device | Class II | 2 |
| 24 Feb 2025 | Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 (96414) | PYRAMES INC | Device | Class II | 1 |
| 24 Feb 2025 | Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RESUSCITATION KIT, REF ACC010381C; 5) PEDS GREY-PINK-RED, REF ACC010395; 6) PEDS PURPLE, REF ACC010397; 7) NEONATAL… | MEDLINE INDUSTRIES, LP - Northfield | Device | Class I | 1 |
| 24 Feb 2025 | Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05. | Imprimis NJOF, LLC | Drug | Class III | 1 |
| 21 Feb 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART. | MEDLINE INDUSTRIES, LP - Northfield | Device | Class I | 4 |
| 20 Feb 2025 | Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N | Microbiologics Inc | Device | Class II | 1 |
| 20 Feb 2025 | Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm H, 7 degrees. | Orthofix U.S. LLC | Device | Class II | 1 |
| 20 Feb 2025 | BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring. (96399) | Individual firm, name withheld | Device | Class II | 1 |
| 20 Feb 2025 | IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. It is indicated for use with the IVX… | Omnicell, Inc. | Device | Class II | 1 |
| 19 Feb 2025 | CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior. (96340) | Calyxo, Inc. | Device | Class I | 1 |
| 19 Feb 2025 | GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043; 8) 2088026-110; 9) 2088026-115; 10) 2088026-132; 11) 2088026-306; 12) 2088026-308; 13) 2088026-406; 14) 2088026-506; 15) 2088026-614; 16)… | GE Healthcare | Device | Class II | 5 |
| 19 Feb 2025 | Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOLLOID,FINGER&TOE,8CT 5) Model Number:… | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 2 |
| 18 Feb 2025 | Choshiya branded "SHIBA ZUKE PREPARED MIX VEGETABLES" UPC# JANCODE 4582207535128 | AKT Trading Inc. | Food | Class I | 6 |
| 17 Feb 2025 | Glicks Dark Chocolate Conettos, 2.47 oz., Plastic Bag, 24 packages per case | Kenover Marketing Corp. | Food | Class I | 1 |
| 15 Feb 2025 | Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart… | Abbott Medical | Device | Class II | 1 |
| 12 Feb 2025 | namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 4 |
| 11 Feb 2025 | Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749 | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 19 |
| 11 Feb 2025 | Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DENTAL PACK, Pack Number DYNJ54064; 5) EAR PACK, Pack Number DYNJ68678C; 6) ENT HEAD NECK PACK, Pack Number DYNJ49023D; 7) ENT… | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 5 |
| 11 Feb 2025 | Rolled Oats packaged in Bulk Poly Supersacks packaged and labeled as follows: 1. 1800 LB Regular Rolled Oats #5, Weight: 1800.00 lb. Product ID: 810239153. Grain Millers, 1 Grain Millers Drive, Yorkton, SK S3N 3Z4. Product of Canada. 2. 1600 LB Quick Rolled Oats #21, Weight: 1600.00 lb. Product ID: 811176. Grain… (96590) | Grain Millers Inc | Food | Class II | 1 |
| 7 Feb 2025 | Las Ollas Botana Mix snack, 2lbs, item #1516, # 1056, UPC# 880342001855 (96282) | Kedake Inc | Food | Class I | 1 |
| 7 Feb 2025 | LEMON PLUM; NET WT: 228G (8oz); INGREDIENTS: Plum, sugar, salt, lemon juice, food additives (citric acid, sodium benzoate, potassium sorbate, ethyl maltol, FD&C YELLOW#6, vanillin, saccharin sodium, sodium metabisulfite), food flavoring; DISTRIBUTED BY RONG SHING TRADING NY INC; UPC: 6922300667599 | Rong Shing Trading NY Inc | Food | Class III | 1 |
| 6 Feb 2025 | Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 3 Feb 2025 | CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for… | St. Jude Medical | Device | Class II | 1 |
| 31 Jan 2025 | Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No | American Contract Systems, Inc. | Device | Class II | 3 |
| 31 Jan 2025 | CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05. | Direct Rx | Drug | Class II | 1 |
| 28 Jan 2025 | SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1 | Ascent Consumer Products Inc. | Drug | Class I | 3 |
| 27 Jan 2025 | Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 9 Jan 2025 | A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System. (96237) | Individual firm, name withheld | Device | Class II | 1 |
| 8 Jan 2025 | babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada. (96334) | Johnson, S C and Son, Inc | Drug | Class II | 1 |
| 31 Oct 2024 | LEGALLY ADDICTIVE THE O.G. COOKIES MADE FROM CRACKERS+TOFFEE+CHOCOLATE+SEA SALT NET WT. 4.7OZ (133G) UPC 8 54766 00802 8 & 1.34OZ (38G) UPC 8 54766 02800 4 (95663) | Legally Addictive Foods | Food | Class II | 1 |
| 12 Jul 2024 | DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids | Beckman Coulter, Inc. | Device | Class II | 1 |
| 5 Oct 2023 | MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2HH1FH2HM2FM2FG1FF, REF: 169-100; BD PYXIS MEDBANK MINI 1HH-1FH- 1HM, REF: 169-101; BD PYXIS MEDBANK… | CareFusion 303, Inc. | Device | Class II | 1 |
| 2 Oct 2023 | Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations (96497) | Edge Biologicals Inc | Device | Class II | 1 |
| 20 Jul 2023 | Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. | Philips Medical Systems Nederland B.V. | Device | Class II | 1 |