| 31 Oct 2025 | Mai California Roll WR - UPC 840031402639 5.9 oz (167g) Plastic tray with plastic lid (97943) | HANA GROUP | Food | Class II | 1 |
| 31 Oct 2025 | Bulk and Organic Organic Moringa Powder, 44.1lbs bag (97925) | BULK & ORGANIC LLC | Food | Class I | 1 |
| 30 Oct 2025 | Monarch Premium Kratom Bali Gold powder is packaged in seal mylar pouches: Monarch Premium Kratom Bali Gold, 4oz powder (112g), UPC 851006008428 Monarch Premium Kratom Bali Gold, 8oz powder (224g), UPC 706970483712 | Lotus Vaping Technologies, LLC | Food | Class I | 4 |
| 30 Oct 2025 | Blue Oven Artisan Bakery English Muffins, Net Wt. 13.4 oz (380g), packaged as a 4-pack in a clear plastic bag, UPC 198715684322 (97922) | Blue Oven Bakery, Inc. | Food | Class II | 1 |
| 29 Oct 2025 | POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14 | Otsuka ICU Medical LLC | Drug | Class I | 2 |
| 29 Oct 2025 | Peach Salsa - $5.99-16 oz 639123940636 packaged in clear plastic clamshells Sell by 11/3/2025 Sell by 11/4/2025 | JFE FRANCHISING INC | Food | Class I | 1 |
| 29 Oct 2025 | Peach Salsa; UPC 85006540364 14oz (397g); Use by 10/12/2025 to 10/29/2025 | GBC Food Services, LLC | Food | Class I | 1 |
| 29 Oct 2025 | Rockport Lobser Bisque; packed in 2x8lb pouches and in 4x4b pouches (97905) | Plenus Group Inc. | Food | Class I | 1 |
| 28 Oct 2025 | Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-046-88. | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 7 |
| 28 Oct 2025 | Dry Ghoinnya Fish (97895) | New Hoque and Sons, Inc. | Food | Class I | 1 |
| 27 Oct 2025 | 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 (97841) | Otsuka ICU Medical LLC | Drug | Class II | 1 |
| 27 Oct 2025 | Carton Label: PACIFIC FRESH VEGETABLES PACIFIC INTERNATIONAL MARKETING SALINAS, CA 93912 Carton Sticker Label: Conv Italian Parsley 60 Ct Ctn Pacific Product of USA Distributed By: Dynasty Farms Salinas, CA 93905 UPC 40695 80125 Twist Tie (for bunches) Label: FLAT PARSLEY PLU #4901 PROUDCT OF USA UPC 40695 80125 | Pacific International Marketing | Food | Class I | 4 |
| 25 Oct 2025 | Item# 28855 Whatcom Blue, Twin Sisters Creamery brand, product is packed in Cryovac and each package weighs 5oz-6oz. There are 16 pieces per case. This cheese is made from raw milk. Ingredients: cultured raw cow's milk, salt, enzymes, penicillium roqueforti. Made by Twin Sisters Creamery in Ferndale, WA. Distributed… | Peterson Company Inc | Food | Class I | 2 |
| 24 Oct 2025 | Deli Express BBQ Pulled Pork on a sesame bun. Net Wt 5.5oz (156g) UPC 0 41433-03087 5. EA Sween Company, Eden Prairie, MN 55344. | E.A. Sween Co. | Food | Class II | 1 |
| 24 Oct 2025 | Twin Sisters Creamery Whatcom Blue cheese, 2.5lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: cultured raw cow's milk, salt, enzymes, penicillium roqueforti. Made in Ferndale, WA. www.twinsisterscreamery.com. | Twin Sisters Creamery, LLC | Food | Class I | 4 |
| 23 Oct 2025 | BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100; | Becton Dickinson & Co. | Device | Class II | 1 |
| 23 Oct 2025 | Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06 | Zydus Pharmaceuticals (USA) Inc | Drug | Class II | 1 |
| 23 Oct 2025 | Strawberry Cheesecake Ice Cream with graham crackers swirl, 12 oz pack, Single Cup Net Wt: 8.75oz, Case of 12 Strawberry Cheesecake with graham cracker swirl, 2.5-gal Tub, Net Weight 14 pounds Labels read in part as "Ice Cream Factory, Distributed by Ice Cream Factory 1201 Ice Cream Way, Lebanon, MO 65536" | Ice Cream Factory, LLC | Food | Class II | 2 |
| 23 Oct 2025 | EchoLakeFoods MF 3067 CNFREE Cage Free Precooked IAF Scrambled Eggs Net Wt. 28 lbs. Bulk. Keep Frozen. Manufactured by: Echo Lake Foods, Inc., 2319 Raymond Ave. Franksville, WI 53126. (97851) | Echo Lake Foods, Inc. | Food | Class I | 1 |
| 22 Oct 2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India | Zydus Pharmaceuticals (USA) Inc | Drug | Class II | 3 |
| 21 Oct 2025 | VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. | Accriva Diagnostics, Inc. | Device | Class III | 1 |
| 21 Oct 2025 | TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04. (97850) | Kenvue Brands LLC | Drug | Class II | 1 |
| 20 Oct 2025 | Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 | Medtronic Perfusion Systems | Device | Class II | 1 |
| 20 Oct 2025 | NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90 | Golden State Medical Supply Inc. | Drug | Class II | 1 |
| 20 Oct 2025 | Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05 | Imprimis NJOF, LLC | Drug | Class III | 1 |
| 20 Oct 2025 | In-shell chicken eggs distributed on Jacob King's farm in Addison, NY (97785) | Individual firm, name withheld | Food | Class I | 1 |
| 18 Oct 2025 | MONARCH Bronchoscope. Model Number: MBR-000211-B | Auris Health, Inc | Device | Class II | 1 |
| 17 Oct 2025 | Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG. | TECHNO-PATH MANUFACTURING LTD. | Device | Class II | 2 |
| 17 Oct 2025 | Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a… | Olympus Corporation of the Americas | Device | Class II | 1 |
| 17 Oct 2025 | BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part:… | CareFusion 303, Inc. | Device | Class I | 1 |
| 17 Oct 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm; | Mozarc Medical US LLC | Device | Class II | 6 |
| 17 Oct 2025 | Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01 (97809) | Aero Healthcare | Drug | Class II | 1 |
| 17 Oct 2025 | CaBOT CREAMERY SEA SALT CARAMEL CHEDDAR SWEET & CHEESY POPCORN 6.0oz bag CONTAINS: SOY & MILK UPC 8 50016 94430 6 MANUFACTURED FOR: VERMONT CHEESE PRODUCTS, INC 60 LAKE STREET, SUITE 2A BURLINGTON, VT 05401 (97829) | Jody's Inc. | Food | Class II | 1 |
| 17 Oct 2025 | Cinnamon Powder; 8oz clear plastic container. Distributed by Haitai Inc. UPC: 0 20914 81415 9 (97836) | Haitai, Inc. | Food | Class II | 1 |
| 16 Oct 2025 | Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography… | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION | Device | Class II | 1 |
| 16 Oct 2025 | VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. | Canon Medical System, USA, INC. | Device | Class II | 1 |
| 16 Oct 2025 | Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11 | Amerisource Health Services LLC | Drug | Class II | 3 |
| 15 Oct 2025 | Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09 | ProRx LLC | Drug | Class II | 7 |
| 15 Oct 2025 | Lucky Foods Cinnamon Powder; 40g (97805) | TBC Distribution Corporate | Food | Class II | 1 |
| 15 Oct 2025 | LO-BOY FOODS; TUNA DELUXE; packaged in 5lb white plastic tubs | Made Fresh Salads Inc | Food | Class I | 2 |
| 14 Oct 2025 | BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341; | Becton Dickinson & Company | Device | Class II | 1 |
| 14 Oct 2025 | Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01 | FARMAKEIO OUTSOURCING LLC | Drug | Class II | 15 |
| 14 Oct 2025 | Publix Rich & Creamy Vanilla Ice Cream | Publix Super Markets, Inc. | Food | Class I | 1 |
| 13 Oct 2025 | TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only | TMJ Solutions Inc | Device | Class I | 1 |
| 13 Oct 2025 | Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7. | Teva Pharmaceuticals USA, Inc | Drug | Class II | 1 |
| 13 Oct 2025 | Specialty Stuft Meats Crawfish Stuft Potato, Net Wt .72 lbs, individually packaged in vacuum-sealed plastic, UPC 642176000172 (97844) | Quality Poultry & Seafood Inc | Food | Class II | 1 |
| 10 Oct 2025 | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MASK DYNJAA10591; ANES CIRC 120IN EXP-LF DYNJAA6555G; ANES CIRCUIT ADULT 120"-LF DYNJAA10817; ANESTHESIA 120" ADLT-LF DYNJAA10775; ANESTHESIA CIRC ADULT 120-LF DYNJAA10601;… | Medline Industries, LP | Device | Class I | 10 |
| 10 Oct 2025 | HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01. (97710) | Samsung Bioepis Co., Ltd. | Drug | Class II | 1 |
| 10 Oct 2025 | R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478. NDC 70092-1433-50 | QuVa Pharma, Inc. | Drug | Class II | 1 |
| 10 Oct 2025 | Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30 | Alembic Pharmaceuticals Limited | Drug | Class III | 1 |
| 10 Oct 2025 | Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91 | Endo USA, Inc. | Drug | Class III | 4 |
| 10 Oct 2025 | Giant/Martin's Crunchy Taco Dinner Kit, Net Wt 9.4 OZ (266g), UPC: 068826757516, DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 Product consists of 12 taco shells, 1 sauce packet, and 1 seasoning packet within a carton; packed 12 cartons per case | Teasdale Foods, Inc. | Food | Class I | 2 |
| 9 Oct 2025 | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and… | Thoratec LLC | Device | Class II | 4 |
| 9 Oct 2025 | 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic | B-K Medical A/S | Device | Class II | 6 |
| 9 Oct 2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922. | Breckenridge Pharmaceutical, Inc. | Drug | Class II | 1 |
| 9 Oct 2025 | Roshni Cinnamon Powder, 3.5 oz (100g). This product is packaged in clear plastic pouches. (97857) | Singh Trading Inc. DBA Roshni Foods | Food | Class II | 1 |
| 8 Oct 2025 | Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that… | Olympus Corporation of the Americas | Device | Class II | 1 |
| 8 Oct 2025 | REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component. (97835) | Cellavision AB | Device | Class II | 1 |
| 8 Oct 2025 | Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR… | Sterilmed, Inc. | Device | Class II | 2 |
| 8 Oct 2025 | Fusia Asian Inspirations brand Veggie Spring Rolls. Net weight: 10 oz (283.5 g).) retail package identified by UPC 4099100222258. Type of packaging: Paperboard carton with inner poly bag; 12 ct corrugated master case. Responsible firm on label: ALDI Inc. Batavia, IL 60510 (U.S. private label). (97774) | Tai Foong USA Inc | Food | Class I | 1 |
| 7 Oct 2025 | SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600 | Philips Respironics, Inc. | Device | Class II | 1 |
| 7 Oct 2025 | GM85 Digital Mobile X-ray imaging System; Model Number: GM85; | NeuroLogica Corporation | Device | Class II | 1 |
| 7 Oct 2025 | Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01. | Trividia Health, Inc. | Device | Class II | 1 |
| 7 Oct 2025 | Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay | Meridian Bioscience Inc | Device | Class II | 2 |
| 7 Oct 2025 | Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10 | Teva Pharmaceuticals USA, Inc | Drug | Class II | 3 |
| 7 Oct 2025 | Loaded Veggie Grain Bowl; Net Wt. 10.90 Oz (309g) GTIN code: 00818905028162 (97948) | FreshRealm | Food | Class II | 1 |
| 7 Oct 2025 | Eagle Spice Ground Ginger 16 oz. (97798) | Eagle Spice and Extract Co., Inc. | Food | Class II | 1 |
| 7 Oct 2025 | " Product Name: Pastured Grade AA Large Eggs " Product Description: Egg Carton, 12 eggs per dozen " Pack/Julian Date(s): Julian date 241(Aug 30) to 244 (Sep 2) and 246 (Sep 4) to 247 (Sep 5), Best by Dates 10/11 to 10/14/25 and 10/16 to 10/17. (97775) | Kenz Henz LLC | Food | Class I | 1 |
| 6 Oct 2025 | OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test) (97860) | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC | Device | Class III | 1 |
| 6 Oct 2025 | Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I | Applied Medical Technology Inc | Device | Class II | 5 |
| 6 Oct 2025 | Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps,… | Olympus Corporation of the Americas | Device | Class II | 2 |
| 6 Oct 2025 | IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6; | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 3 |
| 6 Oct 2025 | Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 | Abbott Medical | Device | Class II | 2 |
| 6 Oct 2025 | Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue.… | Tandem Diabetes Care, Inc. | Device | Class I | 1 |
| 6 Oct 2025 | Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. | Heritage Pharmaceuticals Inc | Drug | Class II | 6 |
| 6 Oct 2025 | RICED CAULIFLOWER IQF NET WEIGHT: 30lbs (13.60 kg) PACK DATE: 08/04/2025 BEST BY: 08/04/2026 INGREDIENTS: CAULIFLOWER PERISHABLE KEEP FROZEN (97791) | Nate's Fine Foods, LLC | Food | Class II | 1 |
| 3 Oct 2025 | MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F. | Medline Industries, LP | Device | Class II | 1 |
| 3 Oct 2025 | MC3 VitalFlow Console, REF 58100; Blood pump of ecmo | Medtronic Perfusion Systems | Device | Class II | 1 |
| 3 Oct 2025 | TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; | Integra LifeSciences Corp. (NeuroSciences) | Device | Class II | 1 |
| 3 Oct 2025 | Frozen Crab Paste; 3.5 OZ (100g); Imported by Mutual Tading Co. Inc. UPC# 72546723040 "Not for retail Sale" Frozen Crab Paste IM-2 in w/Tray; 500g; Imported by Mutual Trading Co. Inc. UPC# 72546607852 "Not for retail Sale" Frozen Crab Paste; 17.6 OZ (500g); Imported by Mutual Tading Co. Inc. UPC# 72546607852 "Not for… (97776) | New York Mutual Trading, Inc. | Food | Class I | 1 |
| 3 Oct 2025 | Frozen Coconut bar Net wt. 4oz (113g) single bars packed in a plastic cup. UPC: 61058590845. Crafted by Fruitique International Miami USA 33016. Phone 1(888)960-6024 (97761) | QUE RIKURA'S PRODUCTS, CORP | Food | Class II | 1 |
| 2 Oct 2025 | CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM 5MM X 17 CM/FCX100517, UNIFORM 6MM X… (97814) | Cerenovus Inc | Device | Class I | 1 |
| 1 Oct 2025 | MAGNETOM Cima.X Upgrade. Model Number: 11689304. | Siemens Medical Solutions USA, Inc | Device | Class I | 1 |
| 1 Oct 2025 | Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus… (97763) | Quest International, Inc. | Device | Class II | 1 |
| 1 Oct 2025 | Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control | Microgenics Corporation | Device | Class II | 1 |
| 1 Oct 2025 | Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue… | ENDOMAGNETICS LTD | Device | Class II | 2 |
| 1 Oct 2025 | Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device | Medline Industries, LP | Device | Class II | 11 |
| 1 Oct 2025 | ProxiDiagnost N90; Model Number: 706110; | Philips Medical Systems DMC GmbH | Device | Class II | 6 |
| 1 Oct 2025 | Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer | Beckman Coulter, Inc. | Device | Class II | 2 |
| 1 Oct 2025 | Carrot Bundt Cake - Net Weight 4 lbs Contains: Wheat, Soy, Milk, Eggs, Tree Nuts No UPC | Individual firm, name withheld | Food | Class I | 2 |
| 30 Sep 2025 | Alcon PRECISION1 One-Day Contact Lenses, -2.25D. | Alcon Research LLC | Device | Class II | 1 |
| 30 Sep 2025 | Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic… | Elekta, Inc. | Device | Class II | 1 |
| 30 Sep 2025 | Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117 | Prismatik Dentalcraft, Inc. | Device | Class II | 1 |
| 30 Sep 2025 | MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M | Medline Industries, LP | Device | Class II | 20 |
| 30 Sep 2025 | Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 138919-01 138920-01 138921-01 138922-01 138923-01 138924-01… | CareFusion 303, Inc. | Device | Class II | 5 |
| 30 Sep 2025 | IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio | IMPRIS Imaging Inc | Device | Class I | 4 |
| 29 Sep 2025 | Big Y Brown Jumbo A 12ct Eggs; UPC: 018894319146 Simple Truth Cage Free Brown Large AA 12ct; UPC: 011110797698 Stater Bros Cage Free Large AA 18ct; 074175001650 That's Smart Cage Free Large AA 60ct; 193476006192 Lindsey s Gold Free Range Brown Large A 12ct; 860011334408 Marketside Cage Free Brown Large A 12ct;… (97907) | EGGS UNLIMITED LLC | Food | Class I | 1 |
| 27 Sep 2025 | Marketside Cheesy Cauliflower Au Gratin 12 oz.; UPC: 10194346375445 (97834) | FreshRealm, Inc | Food | Class II | 1 |
| 26 Sep 2025 | Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Record updated 3/19/26 to include: CARESCAPE B450 MBA313 2095800-001 CARESCAPE MONITOR B450 (ATO MODEL) 2068491-002… | GE Healthcare Finland Oy | Device | Class II | 5 |
| 26 Sep 2025 | Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No (97707) | Individual firm, name withheld | Device | Class II | 1 |
| 26 Sep 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Device | Class II | 24 |
| 26 Sep 2025 | Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis | Zimmer, Inc. | Device | Class II | 2 |
| 26 Sep 2025 | CODMAN Disposable Perforator 11mm. Cranial Perforator. | Integra LifeSciences Corp. (NeuroSciences) | Device | Class I | 2 |
| 25 Sep 2025 | Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flexible distal shaft. The design facilitates… | BALT USA, LLC | Device | Class I | 1 |
| 25 Sep 2025 | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT; | Covidien, LP | Device | Class II | 2 |
| 25 Sep 2025 | Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X; | PHILIPS MEDICAL SYSTEMS | Device | Class II | 3 |
| 24 Sep 2025 | HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY | Stryker Sustainability Solutions | Device | Class II | 1 |
| 24 Sep 2025 | Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A | Aesculap Inc | Device | Class II | 4 |
| 23 Sep 2025 | Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm Head; 3205.45.028 Klassic BiPolar Head, 45 mm… (97708) | Total Joint Orthopedics, Inc. | Device | Class II | 1 |
| 23 Sep 2025 | Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview Dr. Shelton, CT, Made in the USA UPC 738743190015 (97683) | ACME UNITED CORPORATION | Drug | Class II | 1 |
| 23 Sep 2025 | Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1. (97938) | Park Avenue Compounding | Drug | Class II | 1 |
| 22 Sep 2025 | Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6; | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 22 Sep 2025 | DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended… | Beckman Coulter Inc. | Device | Class II | 1 |
| 22 Sep 2025 | Dr. Praeger's, California Veggie Burgers, 10oz, Plastic wrapped burgers inside of a retail box. 6 packages per master case. Keep Frozen (97818) | Individual firm, name withheld | Food | Class II | 1 |
| 20 Sep 2025 | Kroger Raw Colossal EZ Peel Shrimp, net wt. 2lbs., UPC 20011110643906. Product is packaged in transparent printed bag with a blue band on the top with yellow and red details. | Admiralty Island Fisheries Inc dba AquaStar (USA) Corp. | Food | Class II | 9 |
| 19 Sep 2025 | Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030. 2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035. 3. POLYAXIAL SCREW, CC, 5.5mm X 40mm; Item Number: TL1-10755040. 4.… | Orthofix U.S. LLC | Device | Class II | 1 |
| 18 Sep 2025 | Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No | Abbott Laboratories | Device | Class II | 1 |
| 17 Sep 2025 | MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0… (97562) | ELEKTA SOLUTIONS AB | Device | Class II | 1 |
| 17 Sep 2025 | SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 | Beckman Coulter Inc. | Device | Class II | 1 |
| 16 Sep 2025 | SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system | Surgical Theater Inc | Device | Class II | 7 |
| 16 Sep 2025 | Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to… | Spacelabs Healthcare, Ltd. | Device | Class II | 1 |
| 15 Sep 2025 | MIXED NUTS Roasted & Salted NET WT 8 OZ (227g) INGREDIENTS: ALMONDS, WALNUTS, PEANUTS***CASHEWS***HAZELNUTS, BRAZIL NUTS CONTAINS: ALMONDS, BRAZIL NUTS, CASHEWS, PEANUTS, WALNUTS UPC 8 10111 02236 1 DIST BY: HAMPTON FARMS 180 AVOCADO ST. SPRINGFIELD, MA 01104 | Severn Peanut Company LLC | Food | Class II | 2 |
| 12 Sep 2025 | Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B | Medtronic Perfusion Systems | Device | Class II | 1 |
| 12 Sep 2025 | Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 (97660) | Letco Medical LLC | Drug | Class III | 1 |
| 8 Sep 2025 | CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E. | Beckman Coulter, Inc. | Device | Class II | 1 |
| 8 Sep 2025 | ChemoLock Bag Spike, 01 units REF: CL-10-10 | ICU Medical, Inc. | Device | Class II | 38 |
| 5 Sep 2025 | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component | Exactech, Inc. | Device | Class II | 3 |
| 3 Sep 2025 | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. | Fresenius Kabi USA, LLC | Device | Class II | 1 |
| 3 Sep 2025 | Zingerman's Peanut Butter Crush Candy Bar net wt 2oz UPC 844397005237 | Zingerman's Coffee Company | Food | Class I | 2 |
| 2 Sep 2025 | Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the… (97601) | Berkeley Advanced Biomaterials, LLC | Device | Class II | 1 |
| 28 Aug 2025 | Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | Device | Class I | 1 |
| 28 Aug 2025 | Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM) | Vantive US Healthcare LLC | Device | Class II | 1 |
| 27 Aug 2025 | 4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04 | DermaRite Industries, LLC | Drug | Class II | 18 |
| 26 Aug 2025 | Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS. | OSSTEM Implant Co., Ltd. | Device | Class II | 3 |
| 22 Aug 2025 | Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 - Procedure table designed for full fluoroscopic imaging of the urinary tract during video Urodynamics procedures. Component: N/A (97568) | Sonesta Medical AB | Device | Class II | 1 |
| 20 Aug 2025 | MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01 (97470) | MicroSurgical Technology Inc | Device | Class II | 1 |
| 19 Aug 2025 | Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml) | Greiner Bio-One North America, Inc. | Device | Class II | 1 |
| 8 Aug 2025 | Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 | Greiner Bio-One North America, Inc. | Device | Class II | 1 |
| 6 Aug 2025 | Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and… | Cepheid | Device | Class II | 1 |
| 5 Aug 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE 8065753179 UNITY 25+ HYPERVIT 30K VIT… | Alcon Research LLC | Device | Class II | 5 |
| 4 Aug 2025 | PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802. | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 18 Jun 2025 | Product Name: Nutra Calm Package: 175cc HDPE Bottle. Type: Vegetable Capsule Count: 90, Dose: 2 Capsules. Product Sku: PB248 | Professional Botanicals, Inc. | Food | Class II | 3 |
| 16 Jun 2025 | 47518 - Nonpareil, Semi-Sweet Chocolate (Christmas Seeds), 25lb Bulk Cases Packaged into Various Size Units After distribution. | Weaver Nut Company, Inc | Food | Class I | 2 |
| 5 May 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA… (97551) | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Device | Class II | 1 |
| 17 Feb 2025 | 9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009; | DAYE (ANNE'S DAY LTD) | Device | Class II | 29 |
| 10 Jan 2025 | Item IL1014A, PIGGY Lotte Crispy Crunch Ice Cream Cone, Strawberry flavor, Keep Frozen, (4/5/160ML), UPC 8801118255045. Product of Korea. The label of recalled product declared: Ingredients: Cone snack, Strawberry syrup, Biscuit, Chocolate spray, Topping Chocolate, Ice cream mix (Sugar, Mixed milk powder, Processed… (97886) | Seoul Trading, Inc. | Food | Class I | 1 |
| 2 Feb 2023 | BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000; (97742) | Individual firm, name withheld | Device | Class II | 1 |