| 12 Mar 2025 | emd Oysterettes (oyster crackers in polypropylene film). 0.75 oz. Packed for and Distributed by emd, Detroit, MI 48212. (96525) | Dairy State Foods Inc | Food | Class II | 1 |
| 11 Mar 2025 | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05 | FDC Limited | Drug | Class II | 1 |
| 11 Mar 2025 | Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015 | Fruit Of The Earth, Inc. | Drug | Class II | 2 |
| 11 Mar 2025 | Daily Veggies Enoki Mushroom; Product of Korea; Net WT. 200 g (7.05 oz); KEEP REFRIGERATED; Cook through before | New Age International, Inc. | Food | Class I | 1 |
| 7 Mar 2025 | Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04 | Slate Run Pharmaceuticals | Drug | Class II | 2 |
| 7 Mar 2025 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20. | Mylan Institutional, Inc. | Drug | Class II | 2 |
| 5 Mar 2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99 | Rising Pharma Holding, Inc. | Drug | Class II | 1 |
| 5 Mar 2025 | PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30 | Golden State Medical Supply Inc. | Drug | Class II | 1 |
| 4 Mar 2025 | Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0 (96391) | Chattem Inc | Drug | Class II | 1 |
| 3 Mar 2025 | Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627 (96398) | ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY | Device | Class II | 1 |
| 28 Feb 2025 | Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334; | Philips Medical Systems Nederland B.V. | Device | Class II | 1 |
| 28 Feb 2025 | Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10 | Breckenridge Pharmaceutical, Inc. | Drug | Class II | 3 |
| 28 Feb 2025 | Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8 (96395) | Sigan Industries Group Inc. | Drug | Class II | 1 |
| 28 Feb 2025 | Domna's Bakery 24 PC Baklava Tray 330043 8 (96408) | Optima Foods, Inc. | Food | Class II | 1 |
| 28 Feb 2025 | Little Leaf Farms brand Southwest Salad Kit; 7.5 oz, clear plastic clamshell; UPC: 857394006220 (96409) | LITTLE LEAF FARMS LLC | Food | Class I | 1 |
| 27 Feb 2025 | Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC 55513-530-10 (box). | Amgen, Inc. | Drug | Class II | 2 |
| 27 Feb 2025 | Coyote Valley Sour Cream & Onion Chips, Net Wt. 5oz, UPC 744234810775, Item # 8014265, Food Express USA, Dallas, TX 75261 (96403) | Uncle Rays, LLC | Food | Class II | 1 |
| 26 Feb 2025 | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 25 Feb 2025 | Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93 | MYLAN PHARMACEUTICALS INC | Drug | Class II | 1 |
| 24 Feb 2025 | COR Disposable Kit, 8 mm. Cartilage Transplant System. | DePuy Mitek, Inc., a Johnson & Johnson Co. | Device | Class II | 2 |
| 24 Feb 2025 | Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a… (96379) | Kowa Pharmaceuticals America | Drug | Class III | 1 |
| 24 Feb 2025 | Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1 | Denison Pharmaceuticals, LLC | Drug | Class II | 1 |
| 23 Feb 2025 | Chocolate Peanut Butter Protein Balls. Product has expected life of 2 weeks and does not require refrigeration. Product is packaged in sets of 2 protein balls into resealable plastic baggies. Net Wt. 78 grams. (96385) | Prep'd CDA LLC | Food | Class II | 1 |
| 21 Feb 2025 | 1.) Market Pantry Soup & Oyster Crackers, NET WT 9 OZ (255g), packaged in flexible plastic bags, 12 count per case, Distributed By: Target Corporation, Minneapolis, MN 55403 2.) Great Value Soup & Oyster Crackers, NET WT 9 OZ (255g), packaged in flexible plastic bags, 12 count per case, Distributed By: Walmart, Inc.,… | Shearer's Foods, LLC | Food | Class II | 1 |
| 21 Feb 2025 | Ready Care Chocolate Shake (4 oz), UPC 10045796017341; Imperial Chocolate Shake (4 oz), UPC 00074865926997 | Lyons Magnus LLC | Food | Class I | 10 |
| 21 Feb 2025 | CINNABON CLASSIC CINNAMON ROLL INTERNATIONAL delight COFFEE CREAMER 32 FL OZ (1 QT) 946 mL UPC 0 41271 01993 3 Distributed by: Danone US, LLC | Individual firm, name withheld | Food | Class II | 2 |
| 20 Feb 2025 | Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N | Microbiologics Inc | Device | Class II | 1 |
| 20 Feb 2025 | Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency. (96328) | One Source Nutrition, Inc, | Drug | Class I | 1 |
| 20 Feb 2025 | PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1. | Central Admixture Pharmacy Services, Inc. | Drug | Class I | 1 |
| 19 Feb 2025 | MIM software; System, Image Processing, Radiological (96314) | MIM Software Inc | Device | Class II | 1 |
| 19 Feb 2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system. | Merge Healthcare, Inc. | Device | Class II | 5 |
| 18 Feb 2025 | GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed | GE Medical Systems, LLC | Device | Class II | 7 |
| 18 Feb 2025 | BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software | CareFusion 303, Inc. | Device | Class I | 2 |
| 18 Feb 2025 | Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01. (96306) | Turbare Manufacturing | Drug | Class II | 1 |
| 18 Feb 2025 | Dried Longan Pulp- Made in China, 8oz(227g), GROWLAND INC. rear panel- Organic Planted, Store in cool and dry place, Made in Thailand; UPC# 8 513041 327262 (96264) | Growland Inc | Food | Class II | 1 |
| 17 Feb 2025 | Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter. | B Braun Medical Inc | Device | Class II | 1 |
| 17 Feb 2025 | Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM FilterLine H Set Long Infant/Neonatal CO2… | Oridion Medical 1987 Ltd. | Device | Class II | 10 |
| 17 Feb 2025 | Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30. | MEDLINE INDUSTRIES, LP - Northfield | Drug | Class II | 2 |
| 17 Feb 2025 | Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302. | Safecor Health, LLC | Drug | Class II | 5 |
| 15 Feb 2025 | Happy Farms by ALDI Colby Jack (a blend of Colby & Monterey Jack finely shredded cheeses), Net Wt. 12 OZ (340g), packaged in flexible plastic stand-up pouches, 12 pouches per case, UPC 4061463330840, with Best By dates of July 13, 2025 and July 14, 2025. Dist. & sold exclusively by ALDI, Batavia, IL 60510. | Great Lakes Cheese Co Inc | Food | Class II | 1 |
| 15 Feb 2025 | Berry Buddies; Blueberries, Mini Pancakes & Real Maple Syrup; NET WT 2.1 oz (60 g); 3-compartment non-flex plastic container with heat-sealed plastic film containing mini pancakes, blueberries, and maple syrup (96322) | NATURIPE VALUE ADDED FRESH LLC | Food | Class I | 1 |
| 15 Feb 2025 | Ulker Kekstra Mini strawberry, item 3792, 5.3oz foil pack, 10 per case, UPC 8690766082307 | ZB Importing LLC | Food | Class I | 6 |
| 14 Feb 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11 | Waldemar Link GmbH & Co. KG (Mfg Site) | Device | Class II | 3 |
| 14 Feb 2025 | CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100 | Smiths Medical ASD, Inc. | Device | Class II | 2 |
| 14 Feb 2025 | BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC… | CareFusion 213, LLC | Drug | Class I | 1 |
| 14 Feb 2025 | HOT ONES brand VERDE, Los Calientes Hot Sauce, BY HEATONIST; 1 gallon, 5 oz, and 5 gallon sizes; UPC: 8-51444-00803-5 | The Karma Sauce Company LLC | Food | Class II | 2 |
| 14 Feb 2025 | Mauna Loa Milk Chocolate Covered Macadamias product is a snack product and packaged in plastic 1oz pouch. Each carton contains 12 pouches, and each master case contains 12 cartons. Retail Pouch (1oz pouch) UPC: 0 72992 04260 3 Carton (12 pouches) UPC: 72992 04261 Master Case (12 cartons/12 pouches) UPC: 72992 04262… (96317) | Mauna Loa Macadamia Nut Company, LLC | Food | Class I | 1 |
| 13 Feb 2025 | Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRAPE,FEMORAL,RADIAL,5/CS;… | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 8 |
| 13 Feb 2025 | smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24 | Smiths Medical ASD, Inc. | Device | Class I | 12 |
| 13 Feb 2025 | Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035 | Smiths Medical ASD, Inc. | Device | Class I | 1 |
| 13 Feb 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat… | ZOLL Medical Corporation | Device | Class II | 8 |
| 13 Feb 2025 | POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267 | ICU Medical, Inc. | Drug | Class I | 2 |
| 13 Feb 2025 | Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403. | Johnson, S C and Son, Inc | Drug | Class II | 2 |
| 13 Feb 2025 | Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ | Zydus Pharmaceuticals (USA) Inc | Drug | Class II | 2 |
| 12 Feb 2025 | Z1 Femoral Hip System, Product Number 611777612 | Zimmer, Inc. | Device | Class II | 1 |
| 12 Feb 2025 | Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ | Remel, Inc | Device | Class II | 1 |
| 12 Feb 2025 | BD BBL TB Stain Kit K, Catalog (REF): 212522 | Becton Dickinson & Co. | Device | Class II | 1 |
| 12 Feb 2025 | ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01. (96210) | Wuxi Medical lnstrument Factory Co., Ltd. | Drug | Class II | 1 |
| 12 Feb 2025 | Raisin Bran muffins, 6 count. Net Wt. 12.0 oz (0.75 lb) UPC 0 29341-00233 7. Labeled with the following store brands: Cub Foods, Jerrys Foods, and County Market (96295) | JE Bakery 2019 LLC | Food | Class I | 1 |
| 12 Feb 2025 | Good & Gather Cut Green Beans. Net Wt. 14.5 oz (411g). UPC 0 85239-11628 9. Dist. By Target Corporation, Minneapolis, MN 55403. | Del Monte Foods, Inc | Food | Class II | 1 |
| 12 Feb 2025 | Noble Made Garlic Parmesan Wing Sauce, net wt 9.25oz, UPC 850000398542, #0897 BEST BY 06/02/2026 14:02 33724 L1, Code: F20920061 (96288) | Spicin Foods Inc | Food | Class II | 1 |
| 12 Feb 2025 | Chef's Line US Foods, Black Bean Burger, 36/4.25 oz., Product in a plastic bag in a cardboard box. approx. 36 pieces per case. Keep Frozen, | The Fillo Factory Inc. | Food | Class II | 3 |
| 11 Feb 2025 | Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200. | FUJIFILM Healthcare Americas Corporation | Device | Class II | 1 |
| 11 Feb 2025 | Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098 | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 2 |
| 11 Feb 2025 | Black Beans, Dried, net wt. 16 OZ (1 LB) 454g, packaged in plastic bag. Packaged in the U.S. UPC 0 70552 70412 1. DISTRIBUTED BY: WinCo Foods, LLC, BOISE, ID 83704 | Trinidad Benham Corp | Food | Class III | 1 |
| 10 Feb 2025 | Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE | Immuno-Mycologics, Inc | Device | Class II | 1 |
| 10 Feb 2025 | Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 | Brainlab AG | Device | Class II | 1 |
| 10 Feb 2025 | Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09 | Alcon Research LLC | Device | Class II | 1 |
| 10 Feb 2025 | Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50 | Nephron Sterile Compounding Center LLC | Drug | Class II | 1 |
| 9 Feb 2025 | " Spinach Artichoke Dip (Sold Hot) 1 lb " Spinach Artichoke Dip (Sold Cold) 1 lb " Spinach Artichoke Dip (Sold in Bulk for Customer Self Service) (96280) | HEB | Food | Class II | 1 |
| 7 Feb 2025 | Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems. | Cordis US Corp | Device | Class II | 1 |
| 7 Feb 2025 | CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory Model: 18-5000 (96239) | CardioFocus, Inc. | Device | Class II | 1 |
| 7 Feb 2025 | Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping. | Aspen Biopharma Labs Pvt., Ltd. | Drug | Class II | 6 |
| 7 Feb 2025 | Pan de Coco (Coconut Rolls), net wt. 9oz (255g), product is packaged as 6 rolls on a yellow styrofoam plate, then placed in a flexible poly bag with printed label on bag. Product label states Jesse s BAKERY, INC 1101 N. King Street Phone: 842-1120/842-1121 Honolulu, Hawaii 96817. UPC 0 38511 00704 1. The affected… | Jesse's Bakery, Inc. | Food | Class I | 2 |
| 6 Feb 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278 | Beckman Coulter, Inc. | Device | Class II | 1 |
| 6 Feb 2025 | BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01, Used with Enterprise Server (ES), REF: 1115-00… | CareFusion 303, Inc. | Device | Class II | 1 |
| 6 Feb 2025 | LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G | American Contract Systems Inc | Device | Class II | 32 |
| 6 Feb 2025 | AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80 | Integra LifeSciences Corp. | Device | Class II | 1 |
| 6 Feb 2025 | Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01 | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 6 Feb 2025 | Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30 | Padagis US LLC | Drug | Class II | 1 |
| 5 Feb 2025 | Access 2 Immunoassay Analyzer, Catalog Number 81600N | Beckman Coulter, Inc. | Device | Class II | 1 |
| 5 Feb 2025 | Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with… | Medtronic Perfusion Systems | Device | Class I | 1 |
| 5 Feb 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137. | Beckman Coulter, Inc. | Device | Class II | 1 |
| 5 Feb 2025 | Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239 | Bard Peripheral Vascular Inc | Device | Class I | 1 |
| 5 Feb 2025 | IntelePACS (Image Fusion Module) - InteleViewer (96270) | INTELERAD MEDICAL SYSTEMS INCORPORATED | Device | Class II | 1 |
| 5 Feb 2025 | Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX | Baxter Healthcare Corporation | Device | Class I | 2 |
| 5 Feb 2025 | Organic Acai Bowl with berries, bananas, granola and dried coconut; Net Wt. 10 oz (284g); Frozen storage; Packaged in paper bowl with heat-sealed plastic film (96260) | Stiebs, LLC | Food | Class II | 1 |
| 4 Feb 2025 | IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60; | Angiodynamics, Inc. | Device | Class II | 1 |
| 4 Feb 2025 | CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit. | American Contract Systems Inc | Device | Class II | 1 |
| 4 Feb 2025 | Genova branded Solid white Tuna; In Olive Oil; Wild Caught; NET WT. 5 OZ (142g) RD WT. 4 OZ (113g); Distributed by Tri-Union Seafoods, LLC.; El Sugundo, CA 90245 U.S.A. UPC# 48000 00215, | Chicken of the Sea; Thai Union | Food | Class II | 10 |
| 4 Feb 2025 | Item #96507 and item# 32901, King Harvest Balsamic Hummus, net wt. 10oz., UPC 025726 310097, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon. | Pacific Coast Fresh CO | Food | Class II | 12 |
| 3 Feb 2025 | LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest. | Physio-Control, Inc. | Device | Class II | 1 |
| 3 Feb 2025 | VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002 | Ventec Life Systems, Inc. | Device | Class I | 1 |
| 3 Feb 2025 | Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone… (96233) | Medimaps Group | Device | Class II | 1 |
| 3 Feb 2025 | Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis) in mammals. Renal production of EPO is regulated by changes in oxygen availability. Under conditions of hypoxia, the… | Beckman Coulter, Inc. | Device | Class II | 1 |
| 31 Jan 2025 | SIGNA Creator, SIGNA Explorer, NMRI systems | GE Healthcare (China) Co., Ltd. | Device | Class II | 5 |
| 31 Jan 2025 | DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement | DeRoyal Industries Inc | Device | Class II | 1 |
| 31 Jan 2025 | Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM; (3) REF BJ511R, Holzbach Hyst Forceps CVD245MM; (4) REF BJ520R, Heaney Hyst Forceps Grooved 205MM; (5) REF BJ521R, Heaney Hyst Forceps Grooved 250MM; (6)… | Aesculap Inc | Device | Class II | 5 |
| 31 Jan 2025 | Paradigm REF: MMT-712 and MMT-715 | Medtronic MiniMed, Inc. | Device | Class II | 12 |
| 31 Jan 2025 | Gerber Snacks for Baby Soothe 'n' Chew TEETHING STICKS Strawberry Apple NET WT 3.2 OZ (90g) UPC 0 15000 04518 7 GERBER PRODUCTS CO., FREMONT, MI 49413 | Nestle-USA, Inc. (Corporate Office) | Food | Class I | 2 |
| 31 Jan 2025 | Aleppo Tahini Sesame Paste, 32oz, Plastic jar, 1lb (16oz), 12 per case | Turkana Food Inc. | Food | Class I | 1 |
| 31 Jan 2025 | Beverage Base Lemonade, 3 gallon, BIB: Best By 12/12/2025; Beverage Base Lemonade, 5 gallon, BIB: Best By 01/12/2026 | OCBW INC | Food | Class II | 2 |
| 30 Jan 2025 | Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01 | LEICA BIOSYSTEMS NUSSLOCH GMBH | Device | Class II | 1 |
| 30 Jan 2025 | Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009; (96230) | Telcare, LLC | Device | Class II | 1 |
| 30 Jan 2025 | Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14,… | Micro Therapeutics, Inc. | Device | Class I | 2 |
| 29 Jan 2025 | Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197 | Stryker Corporation | Device | Class II | 1 |
| 29 Jan 2025 | PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL | Pentax of America Inc | Device | Class II | 3 |
| 28 Jan 2025 | Garden Salad 5 oz Lot # 6620223 Best By: 02.05, UPC 766375733300 (96211) | FRESHPOINT CENTRAL FLORIDA, INC. | Food | Class I | 1 |
| 28 Jan 2025 | Madras Curry Powder sold in 3 different package sizes. Recall has been expanded to include ALL LOTS. CA RI NI AN DO "KIM TU THAP", NET WT./ Poids NET (4oz.) 114 grams glass jar UPC# 39606001562 (4oz.) 114 grams plastic pouch UPC# 36906001544 (16oz.) plastic bottle UPC# 39606001548 (96229) | Trong Food International | Food | Class II | 1 |
| 27 Jan 2025 | TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP (96274) | TAS Medical Inc | Device | Class II | 1 |
| 27 Jan 2025 | ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. GA4515MP Model/Catalog Number: ETRGA4515MP | Hiossen Inc. | Device | Class II | 6 |
| 25 Jan 2025 | ASIN B084PZ7K98, Amazon Fresh Jumbo Sugar Cookie, 27 oz (12 count), product is baked and packaged in flexible plastic bag. 4-day shelf life. UPC 465712007998. ASIN B084PX9V31, Amazon Fresh Jumbo Sugar Cookie, 2.3 oz (1 count), product is baked and sold from open pastry tray in store. 0 day shelf life. No UPC. | Amazon Retail LLC | Food | Class I | 2 |
| 24 Jan 2025 | 5912MOD-CAU 11" Gluten Free Friendly Cauliflower Shell; Bulk packaged in a blue poly bag, within a corrugated box. 20 units per case; Product UPC: 074542659125; Master Case GTIN: 00074542659125 (96190) | Deiorio Foods Inc | Food | Class II | 1 |
| 23 Jan 2025 | BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration | CareFusion 303, Inc. | Device | Class II | 1 |
| 23 Jan 2025 | BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended to securely store and dispense medications and supplies to a qualified and authorized user in a clinical setting. | CareFusion 303, Inc. | Device | Class II | 1 |
| 23 Jan 2025 | (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System. | LUMENIS, LTD. | Device | Class II | 1 |
| 21 Jan 2025 | A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708041 | Tyber Medical | Device | Class II | 18 |
| 19 Jan 2025 | FOOD SERVICE - Mombo s Vanilla Soft Serve Ice Cream Mix, frozen & thawed for Ice cream machines. Packaged in a half gallon carton 64 oz and placed in cases of 6-units. Shelf-life is 18 months frozen / 30 days thawed refrigerated. Carton is a plain white carton with a sticker label on one side and a code on the gable… (96165) | Arizona Foods Group, Inc. | Food | Class I | 1 |
| 18 Jan 2025 | Idaho Pacific Fine Potato Flour, product #20501, packaged in multi-walled Kraft bag, Net Wt. 50lbs. No UPC code. Manufactured by Idaho Pacific Corporation, Ririe, ID 83443. (96199) | Idaho Pacific Corporation | Food | Class II | 1 |
| 17 Jan 2025 | Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets (gummies), Flexible Sachet packaging, Sample size package (4 Count), EXP: JUL/2025 Lot : 2413352PSF (96225) | Health and Happiness (H&H) LLC. | Food | Class II | 1 |
| 16 Jan 2025 | Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures. | Scientia Vascular, Inc. | Device | Class II | 1 |
| 16 Jan 2025 | Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A (96240) | Spectrum Medical Inc | Device | Class II | 1 |
| 15 Jan 2025 | ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135. (96176) | Individual firm, name withheld | Device | Class II | 1 |
| 10 Jan 2025 | DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software. (96193) | BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. | Device | Class II | 1 |
| 10 Jan 2025 | BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides. | CareFusion 303, Inc. | Device | Class II | 1 |
| 9 Jan 2025 | CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126) | Kung Shin Plastics Co. Ltd. | Device | Class II | 2 |
| 8 Jan 2025 | 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139002-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139000-01 BD PYXIS MEDBANK MN 200 CR-4HH-P 139020-01 BD… | CareFusion 303, Inc. | Device | Class II | 4 |
| 5 Jan 2025 | VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The… | Biosense Webster, Inc. | Device | Class I | 1 |
| 2 Jan 2025 | Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke | Scientia Vascular, Inc. | Device | Class II | 1 |
| 30 Dec 2024 | Assorted Chocolate Caramels with kosher sea salt, Net Weight 1.25lb (96219) | V Chocolates, Inc | Food | Class II | 1 |
| 27 Dec 2024 | Green Chile Bean Burrito, 15 days refrigerated at 33 45 degrees Fahrenheit. 120 days frozen at or below 32 degrees Fahrenheit. Packaged in cellophane wrapper. Net wt. 10 ounces, UPC #21856 11136. Mi Ranchito Foods, Inc. 606 Central Avenue, Bayard, NM 88023 (96283) | Mi Ranchito Foods, Incorporated | Food | Class II | 1 |
| 20 Dec 2024 | Rajbhog Sweets Jelebi Orange, 9.5 oz packages and sold by weight from bulk trays. | Rajbhog Distributors TX Inc. | Food | Class II | 3 |
| 4 Dec 2024 | Mi More snacks, Coco Bandera, 3 oz. Plastic container, 8 per container, 20 per case box (96254) | San Miguel Nuts Corp. | Food | Class III | 1 |
| 29 Nov 2024 | Garden Salad 12 oz Family Garden Salad 24 oz packed in clamshells | JFE FRANCHISING INC | Food | Class I | 6 |
| 13 Nov 2024 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137 | Beckman Coulter, Inc. | Device | Class II | 1 |
| 18 Oct 2024 | human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use. (96137) | HUMAN MED AG | Device | Class II | 1 |
| 9 Aug 2024 | Vios Monitoring System Bedside Monitor Model BSM2050 | Murata Vios, Inc. | Device | Class II | 1 |
| 4 Apr 2024 | Philips IntelliSpace Cardiovascular software, Model 830089. | Philips Medical Systems Nederland B.V. | Device | Class II | 1 |
| 27 Dec 2023 | Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/A (96246) | TruAbutment Inc. | Device | Class II | 1 |
| 15 Nov 2022 | ORGEAT ALMOND SYRUP; 32 fl oz (946 ml); Glass bottle with screw-top lid; Contains: Sugar, Water, Citric Acid Natural Flavor, Sodium Benzoate; Refrigerate after opening (96265) | A C Calderoni & Co. Inc. | Food | Class II | 1 |