| 15 Nov 2024 | Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC# 68645-610-90. Event 95749 | Evaric Pharmaceuticals Inc. | Drug | Class II | 1 |
| 11 Nov 2024 | Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01 | Safecor Health, LLC | Drug | Class II | 5 |
| 7 Nov 2024 | Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72 | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Drug | Class II | 2 |
| 6 Nov 2024 | BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 19th Ave, Phoenix, AZ, NDC 81483-0041-1 | Tailstorm Health INC | Drug | Class II | 1 |
| 6 Nov 2024 | Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC 802992001009 Event 95587 | Trinity Gold Nutrition | Drug | Class II | 1 |
| 5 Nov 2024 | Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Drug | Class III | 1 |
| 1 Nov 2024 | Great Value Cheese Danish 16.5 oz UPC 078742201177, 12 retail units per case | The JM Smucker Company LLC | Food | Class II | 2 |
| 31 Oct 2024 | Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3 | Noven Pharmaceuticals Inc | Drug | Class II | 1 |
| 30 Oct 2024 | Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01 | Baxter Healthcare Corporation | Drug | Class II | 1 |
| 29 Oct 2024 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05. | FDC Limited | Drug | Class II | 1 |
| 29 Oct 2024 | IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05 Event 95620 | Name withheld | Drug | Class III | 1 |
| 29 Oct 2024 | Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. | VIONA PHARMACEUTICALS INC | Drug | Class II | 1 |
| 29 Oct 2024 | Aldi Emporium Selection Brie 8oz UPC 4099100084016; 12 retail units per case La Bonne Vie Brie 8oz UPC 820581678531; 6 retail units per case (No Brand) Industrial Brie 8oz UPC 077901005229; 12 units per case Supreme Brie 7oz UPC 071448504214; 6 retail units per case Market Basket Brie 8oz UPC 049705666302; 6 retail… | SAVENCIA CHEESE USA | Food | Class II | 3 |
| 25 Oct 2024 | U-BAKE Apple Pie, frozen product and packaged in LDPE bag, net wt. 2lbs. 9oz. Made by Grand Central Baking Company. Label declares Wheat and Milk. | Grand Central Bakery FRE Co Inc | Food | Class I | 4 |
| 25 Oct 2024 | BELEVINI, DRIED FRUIT MIX (Apples, Pears & Plums w/pit), 500g, PLASTIC SOFT PACK, 6 PACKAGES PER CASE | MAMTAKIM, Inc. | Food | Class II | 1 |
| 23 Oct 2024 | Clean Catch Kit, SKU DYKM1833A; Component No. 503581 | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 8 |
| 23 Oct 2024 | Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India | Lupin Pharmaceuticals Inc. | Drug | Class II | 3 |
| 23 Oct 2024 | Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98 | Cipla USA, Inc. | Drug | Class II | 2 |
| 23 Oct 2024 | Item #473015 Simplot seasoned CRISP Delivery+ Savory 6 Cut Crinkle Cut Wedge, Frozen Potatoes, 5lb. bag without any labeling, 6 bags per case, SKU 10071179473015. Packaging Distribution Information: J.R. Simplot Company P.O. Box 9386, Boise, ID 83707. Ingredients: POTATOES, VEGETABLE OIL (SOYBEAN, CANOLA, AND/OR… Event 95651 | Name withheld | Food | Class II | 1 |
| 22 Oct 2024 | Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197 | ICU Medical, Inc. | Device | Class I | 1 |
| 22 Oct 2024 | Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01. | Name withheld | Drug | Class II | 2 |
| 22 Oct 2024 | Item Number PACK/SZ BRAND DESCRIPTION Lot Codes 082076 4/5 LBS IMPERIALFRESH PROC ONION YELLOW JULIENNE 3/8 All lot codes; 170992 4/5 LB IMPERIALFRESH PROC ONION YELLOW DICED 3/8 All lot codes; 258147 4/5LBS IMPERIALFRESH PROC ONION YELLOW JULIENNE 1/4 All lot codes; 259369 1 / 5 LB IMPERIALFRESH PROC ONION YELLOW… | FreshPoint Denver, Incorporated | Food | Class I | 2 |
| 22 Oct 2024 | raw, yellow onions (sliced, diced, slivered, ringed), intended for food service, packaged in plastic bags | Taylor Farms Colorado, Inc. | Food | Class I | 4 |
| 21 Oct 2024 | Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 21 Oct 2024 | Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches) | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 21 Oct 2024 | Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC Event 95607 | Name withheld | Device | Class II | 1 |
| 21 Oct 2024 | JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357 | Biomet, Inc. | Device | Class II | 1 |
| 21 Oct 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis | Baxter Healthcare Corporation | Device | Class I | 10 |
| 21 Oct 2024 | Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24 Event 95590 | BLI International, Inc. | Drug | Class II | 1 |
| 18 Oct 2024 | Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional. | Zyno Medical LLC | Device | Class II | 1 |
| 17 Oct 2024 | cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 17 Oct 2024 | Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile | Abbott Medical | Device | Class II | 5 |
| 17 Oct 2024 | Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-10 | Keystone Industries | Drug | Class II | 1 |
| 16 Oct 2024 | Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive. | Baxter Healthcare Corporation | Device | Class I | 1 |
| 16 Oct 2024 | Acrobat-i Positioner. Model Number C-XP-5000Z | Maquet Cardiovascular, LLC | Device | Class II | 3 |
| 15 Oct 2024 | Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 15 Oct 2024 | a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61… | Alcon Research LLC | Device | Class III | 1 |
| 15 Oct 2024 | OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours. Event 95581 | OrganOx Ltd | Device | Class II | 1 |
| 15 Oct 2024 | Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable | Draeger Medical, Inc. | Device | Class I | 2 |
| 15 Oct 2024 | All Raw Vegan Certified Organic Salsa, Glaser Organic Farms, Handmade fresh from our farm to you,Net wt. 8 oz, Plastic PET Container with cover, Keep Refrigerated, UPC 832910 001514 Event 95565 | Glaser Organic Farms | Food | Class II | 1 |
| 14 Oct 2024 | Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 | Cook Incorporated | Device | Class II | 1 |
| 12 Oct 2024 | Home Alone International Delight Peppermint Mocha Zero Sugar, 32oz plastic bottle, 6 bottles per case. Refrigerated. | DANONE US LLC | Food | Class II | 1 |
| 11 Oct 2024 | Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring | Baxter Healthcare Corporation | Device | Class II | 6 |
| 11 Oct 2024 | Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05 | Padagis US LLC | Drug | Class III | 1 |
| 11 Oct 2024 | Kirkland Signature Unsalted Sweet Cream Butter, Net Wt 16 oz (1 lb) 453g, Four 4 oz (113g) sticks UPC 96619-38496. | CONTINENTAL DAIRY FACILITIES SOUTHWEST LLC | Food | Class II | 2 |
| 11 Oct 2024 | Sprouts Chicken Street Taco, 6 taco, perishable item kept under refrigeration, packaged in a plastic tray with plastic lid, Net wt of 1.5lbs, UPC 205916813991. Sell by dates of 9/2/2024 to 11/7/2024. | Sprouts Farmers Market | Food | Class II | 1 |
| 11 Oct 2024 | Home Chef Chicken Street Taco, Net Wt. 9.93 oz, packaged in a plastic tray with clear plastic lid, perishable item kept under refrigeration, UPC 84013430435, all lot codes | The Kroger Co | Food | Class II | 2 |
| 11 Oct 2024 | Pepperjack Cheese Burger, Dakota Toms brand, Net Wt 5.7 oz, individual pre-packaged components in MEP packaging, UPC 737296806008 | Dakota Tom's, Inc | Food | Class I | 3 |
| 10 Oct 2024 | Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites. Event 95604 | Philips Medical Systems Technologies Ltd. | Device | Class II | 1 |
| 10 Oct 2024 | Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000. | Boston Scientific Corporation | Device | Class I | 7 |
| 10 Oct 2024 | Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA. | ACCORD HEALTHCARE, INC. | Drug | Class II | 3 |
| 10 Oct 2024 | New Horizen Gourmet BBQ Pulled Chicken Sandwich on Everything Bialy; KEEP FROZEN; COOK & SERVE; Cooking Instructions: Conventional oven (Preheat oven to 350oF). Thaw product overnight. Cook meal for 20 mins or until an internal temp of 165oF. For quality purposes only, cook product within 72 hours from thawing; Not… Event 95523 | Whitsons Food Service (Bronx), LLC | Food | Class II | 1 |
| 10 Oct 2024 | (Principal Display) ENOKI MUSHROOM Champignons d'enoki Net Wt: 150g (5.3oz) in a clear plastic packaged. (Back Display) UPC 860011505600 Keep Refrigerated Garder Au Froid Distributed by: Global Fresh Marketing Commerce, CA 90040 Event 95522 | Enoki King Mushroom Farm Inc. | Food | Class I | 1 |
| 10 Oct 2024 | Item 407118, UPC 13454 38493, Bistro 28 Creamy Green Chile Chicken Enchilada Express Meal Kit. Make 6 Enchiladas. Ready in 5 MIN. Net wt. 27 oz (1 LB 11 OZ) 765g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384937, Case UPC 13454 38493, Bistro 28 Creamy Green Chile Chicken Enchilada Express Meal… | Reser's Fine Foods, Inc. | Food | Class I | 18 |
| 9 Oct 2024 | VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. | The Metrix Company | Device | Class II | 16 |
| 9 Oct 2024 | Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30. | Name withheld | Drug | Class II | 3 |
| 9 Oct 2024 | The outer package of the recalled product, Shirakiku Korean Seasoned Seaweed Korean Seaweed, is INCORRECTLY labeled as follows: (Principal Display Panel) Roasted Seaweed 10-0.91 OZ (26 G) PACKAGES (NET WT 9.1 OZ (260 G). (Back Display) ROASTED SEAWEED Organic Yaki Nori Ingredients: Organic Seaweed. Distributed by… | Wismettac Asian Foods, Inc. | Food | Class I | 1 |
| 9 Oct 2024 | Chicken Alfredo Kit Event 95562 | Joseph Seviroli, LLC | Food | Class I | 1 |
| 8 Oct 2024 | MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery. | ETHICON, INC. | Device | Class II | 1 |
| 8 Oct 2024 | Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G | Cook Incorporated | Device | Class II | 2 |
| 8 Oct 2024 | Del Monte Fresh Produce, Pineapple and Apple Salad 4/6.5oz plastic container, four containers per case. Refrigerated. Lot Code 02277101, expiration date 10/10/2024 . Event 95521 | Del Monte Fresh Produce N.A., Inc. | Food | Class II | 1 |
| 7 Oct 2024 | Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at… | Philips Respironics, Inc. | Device | Class I | 7 |
| 7 Oct 2024 | Philips Zenition 50, Model Number: 718096 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 2 |
| 7 Oct 2024 | Douglas Labs Stress-B-Plus Dietary Supplement, Tablets, 90 tablets per bottle. UPC # 10539 97452, Lot Numbers ,50335944 and 50344396. Expiration Date 04/11/2026 Event 95519 | Nestle Product Technology Center - Nestle Health Science | Food | Class II | 1 |
| 4 Oct 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. | Caire, Inc. | Device | Class II | 4 |
| 4 Oct 2024 | microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures. | FHC, Inc. | Device | Class I | 1 |
| 4 Oct 2024 | CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 2 |
| 4 Oct 2024 | Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-047-000 | Stryker Corporation | Device | Class II | 6 |
| 4 Oct 2024 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720 | Hobbs Medical, Inc. | Device | Class II | 9 |
| 4 Oct 2024 | Los Andes Foods Sweet Corn Pancakes, Cachapas de Maiz, NET WT. 24 Oz., 5 units, KEEP REFRIGERATED Event 95506 | Tipical Latin Food, Corp. dba La Pradera | Food | Class I | 1 |
| 3 Oct 2024 | GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02030900, 1495-1-Centricity Universal Viewer Zero Footprint /… | GE Healthcare | Device | Class II | 1 |
| 3 Oct 2024 | Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery | Medtronic Perfusion Systems | Device | Class II | 1 |
| 3 Oct 2024 | DeRoyal C-SECTION TRACEPACK, REF 89-9338-06 | DeRoyal Industries Inc | Device | Class II | 4 |
| 3 Oct 2024 | MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item Number: 720001B0 | Getinge Usa Sales Inc | Device | Class II | 8 |
| 3 Oct 2024 | Bulk Mexican sweet bread varieties including conchas, fino ellotes, fino curenos, danes ellotes, danes cuernos, bolillos, and teleras. Bakery products are packaged in unlabeled poly bags. Event 95482 | EM Tortillas, LLC | Food | Class II | 1 |
| 2 Oct 2024 | smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | Smith & Nephew Inc | Device | Class II | 2 |
| 2 Oct 2024 | smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic | Smith & Nephew Inc | Device | Class II | 2 |
| 2 Oct 2024 | Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 | Baxter Healthcare Corporation | Device | Class II | 1 |
| 1 Oct 2024 | Jack & the Green Sprouts Alfalfa, Net Weight 5 oz (142g). UPC 7 63247-19891 5 Keep Refrigerated. Product of USA. Jackandthegreensprouts.com, River Falls, WI 54022. EXPANDED 10/4/2024: Product was packaged in 5 oz containers that were packed in 6 count or 12 count shipping containers, or in a 5lb. bulk tray. Bulk… | Jack & The Green Sprouts, Inc. | Food | Class I | 2 |
| 30 Sep 2024 | Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13 CM, REF: MQ1213 | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 30 Sep 2024 | The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems. | Beckman Coulter, Inc. | Device | Class II | 1 |
| 30 Sep 2024 | IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282) | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 30 Sep 2024 | Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm PM10.0-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x… | NuVasive Specialized Orthopedics, Inc. | Device | Class II | 1 |
| 30 Sep 2024 | Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317 Event 95503 | Staska Pharmaceuticals, Inc. | Drug | Class I | 1 |
| 29 Sep 2024 | Westby Cheese Curds, UPC 7 50388-30105 2. Keep Refrigerated. No Added Preservatives. Manufactured by Westby Cooperative Creamery, Westby, WI 54667. White, Yellow, and Mixed Curds are packaged in 12 oz. (340g) bags or in 10 lb. bulk boxes. | Westby Cooperative Creamery | Food | Class II | 2 |
| 27 Sep 2024 | AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter. | Accriva Diagnostics, Inc. | Device | Class II | 1 |
| 27 Sep 2024 | 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, corrugated plastic tubes that provide a flexible, low resistance lightweight connection between breathing circuits and patient… | Westmed, Inc. | Device | Class II | 1 |
| 26 Sep 2024 | Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 | Integra LifeSciences Corp. | Device | Class II | 1 |
| 26 Sep 2024 | AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420 | King Systems Corp. dba Ambu, Inc. | Device | Class II | 8 |
| 25 Sep 2024 | intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20; DAB kit, REF:… | Biocare Medical, LLC | Device | Class II | 1 |
| 25 Sep 2024 | Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator… | Elekta Instrument AB | Device | Class I | 1 |
| 25 Sep 2024 | Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777 | Cardinal Health 200, LLC | Device | Class I | 1 |
| 25 Sep 2024 | Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H | Ethicon, Inc. | Device | Class II | 1 |
| 25 Sep 2024 | Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155 | Denison Pharmaceuticals, LLC | Drug | Class III | 2 |
| 24 Sep 2024 | Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in… | Olympus Corporation of the Americas | Device | Class II | 1 |
| 24 Sep 2024 | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 | Siemens Healthcare Diagnostics Inc | Device | Class II | 1 |
| 24 Sep 2024 | Brand Name: Vial2Bag Advanced Product Name: Vial2Bag Advanced 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicable Product Description: The Vial2Bag Advanced 20mm Admixture Device is a single use, fluid transfer device that allows for the reconstitution and transfer of fluids from… Event 95449 | West Pharmaceutical Services AZ, Inc. | Device | Class II | 1 |
| 23 Sep 2024 | KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000 | Pro-Dex Inc | Device | Class II | 1 |
| 20 Sep 2024 | VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500 | Maquet Cardiovascular, LLC | Device | Class I | 1 |
| 20 Sep 2024 | remel BactiDrop Acridine Orange, REF 21502, 50 per package. | Remel, Inc | Device | Class II | 1 |
| 20 Sep 2024 | Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018 | AVID Medical, Inc. | Device | Class II | 73 |
| 20 Sep 2024 | MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID Material with x-ray detectable markers. All patties have a suture string attached for ease in performing postsurgical count verification. The surgical patties and surgical strips are… | Integra LifeSciences Corp. | Device | Class II | 22 |
| 19 Sep 2024 | Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US), 12mm x 40mm x 75cm (CFN CH12-40-75US) | Covidien LP | Device | Class II | 1 |
| 19 Sep 2024 | NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components. Event 95598 | Novosource, LLC | Device | Class II | 1 |
| 18 Sep 2024 | Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep Brain Stimulation (DBS) system. WR9220A is… Event 95465 | Name withheld | Device | Class II | 1 |
| 18 Sep 2024 | a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304, P7900B000005, P7900B100011, P7900B100025, P7900B100212, P7900B100277, P7900B100307, P7900B000010, P7900B100017, P7900B100026, P7900B100222, P7900B100281,… | Baxter Healthcare Corporation | Device | Class II | 1 |
| 18 Sep 2024 | Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box | Nihon Kohden America Inc | Device | Class II | 2 |
| 18 Sep 2024 | Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy… | Olympus Corporation of the Americas | Device | Class II | 1 |
| 18 Sep 2024 | Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S x inches or 6mm x 6mm) Component: N/A Event 95464 | American Surgical Company, LLC | Device | Class II | 1 |
| 17 Sep 2024 | Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. | Canon Medical System, USA, INC. | Device | Class II | 1 |
| 17 Sep 2024 | Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. Item Number: VPX4000 (7273) | Zimmer, Inc. | Device | Class II | 1 |
| 17 Sep 2024 | MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01 | Datascope Corp. | Device | Class II | 1 |
| 17 Sep 2024 | The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices. It is intended for processing and displaying ophthalmic images and optical coherence tomography… | Topcon Medical Systems, Inc. | Device | Class II | 1 |
| 16 Sep 2024 | Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy | Percussionaire Corporation | Device | Class I | 1 |
| 16 Sep 2024 | ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1 Event 95459 | ImaCor Inc. | Device | Class II | 1 |
| 16 Sep 2024 | Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000) | Ambu Inc. | Device | Class II | 1 |
| 13 Sep 2024 | 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292 | DRG International, Inc. | Device | Class III | 1 |
| 13 Sep 2024 | Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A | Olympus Corporation of the Americas | Device | Class II | 1 |
| 13 Sep 2024 | Aunt Millie s Bakehouse Hawaiian Hamburger Buns 4.5" Sliced 3 OUNCE. 6 unlabeled 12CT PKGS per sale unit case, product code 7430. Net Wt. 13lb 8oz. | Perfection Bakeries LLC | Food | Class I | 7 |
| 12 Sep 2024 | iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion. Event 95462 | Iotamotion Inc | Device | Class III | 1 |
| 12 Sep 2024 | Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091 | Abbott Molecular, Inc. | Device | Class II | 2 |
| 12 Sep 2024 | Berkeley Springs Water Purified , Berkeley Springs Water Distilled , One Gallons & Five Gallons, Plastic, 6 gallons in one case and1 individual 5 Gallon, Codes 090326,090426,090526,090626. Event 95467 | Berkeley Club Beverages, Inc. | Food | Class III | 1 |
| 11 Sep 2024 | Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product Description: The Olympus UroPass Ureteral… | Olympus Corporation of the Americas | Device | Class II | 1 |
| 6 Sep 2024 | EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor Rx, Cx.PC.IN.SUM.BK.Rx; Martinez Black Cx Rx, Cx-3.PC.PT.MTZ.BK.Rx Event 95461 | Enchroma Inc | Device | Class II | 1 |
| 6 Sep 2024 | SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography. | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION | Device | Class II | 2 |
| 5 Sep 2024 | Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. | Beckman Coulter, Inc. | Device | Class II | 1 |
| 4 Sep 2024 | Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U | Olympus Corporation of the Americas | Device | Class II | 1 |
| 4 Sep 2024 | The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop… | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 3 Sep 2024 | Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX Snap has a unique set of 2 or more reflective… Event 95424 | Trackx Technology Inc | Device | Class III | 1 |
| 30 Aug 2024 | LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator. | Physio-Control, Inc. | Device | Class II | 1 |
| 30 Aug 2024 | Hammond's Dark Chocolate Filled Mini Waffle Cones, packaged in a 4 oz (113g) Stand-Up Resealable Pouch. Item Number: FC23212; UPC 6 91355 90513 5. Label declares ***CONTAINS: WHEAT, SOY, TREE NUTS (COCONUT)***PACKAGED IN A FACILITY THAT PROCESSES EGG, MILK, MUSTARD, PEANUTS, SESAME, SOY, SULFITES, TREENUTS, WHEAT. Event 95297 | Name withheld | Food | Class II | 1 |
| 23 Aug 2024 | Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141) | Olympus Corporation of the Americas | Device | Class II | 1 |
| 23 Aug 2024 | Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004 Event 95439 | Princeton Biomeditech Corp | Device | Class II | 1 |
| 21 Aug 2024 | MyChai Chai Tea Concentrate Original. Product is packaged in plastic (HDPE) 1/2gallon bottle, cap has a foil liner that is induction sealed during the bottling process. Shelf stable 3 year expiration from date of manufacture. Ingredients: Water, Sugar, Organic Black Tea, Organic Spices, Molasses, Vanilla Extract,… | My Chai Inc | Food | Class II | 14 |
| 9 Aug 2024 | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40… | Direct Rx | Drug | Class II | 1 |
| 16 Jul 2024 | CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-2101-0200-17, 21-2101-0200-238,… | Smiths Medical ASD Inc. | Device | Class I | 1 |
| 26 Jun 2024 | smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps | Smiths Medical ASD, Inc. | Device | Class II | 1 |
| 6 Jun 2023 | GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-01052324; 4) 2082844-001-01052572; 5) 2082844-001-01055337; 6) 2082844-001-01065693; 7) 2082844-001-01069008; 8) 2082844-001-01073750; 9)… | DATEX--OHMEDA, INC. | Device | Class I | 2 |
| 11 Jul 2022 | SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198 Event 95490 | WISSNER-BOSSERHOFF GMBH | Device | Class II | 1 |
| 29 Apr 2022 | Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intended for single patient use only. | Nihon Kohden America Inc | Device | Class II | 1 |