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High RiskFDA
Beckman Coulter, Inc.
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Diagnostic Devices·1,272 affected·Nov 26, 2025
High RiskFDA
Beckman Coulter, Inc.
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Diagnostic Devices·6,457 affected·Nov 26, 2025
CriticalFDA
Medline Industries, Lp
MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pack,REF MDR107003E-4.
Medical Devices·138,412 affected·Nov 26, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1...
Medical Devices·11,173 affected·Nov 26, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DY...
Medical Devices·32 affected·Nov 26, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Ki...
Medical Devices·10 affected·Nov 26, 2025
CriticalFDA
Medline Industries, Lp
MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO
Medical Devices·15,581 affected·Nov 26, 2025
High RiskFDA
Remote Diagnostic Technologies Ltd.
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: ...
Medical Devices·7,129 affected·Nov 26, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1...
Medical Devices·1,725 affected·Nov 26, 2025
High RiskFDA
Cook Incorporated
R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is inten...
Diagnostic Devices·23 affected·Nov 26, 2025
CriticalFDA
Medline Industries, Lp
MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
Medical Devices·13,245 affected·Nov 26, 2025
High RiskFDA
Celebration Herbals Us
Celebration Herbals Senna Leaf Herbal Tea 24 Teabags, net wt. 1.48oz. UPC 628240201829
Beverages·1,226 affected·Nov 25, 2025
High RiskFDA
Imu-tek Animal Health, Incorporated
Imu-Tek Immuno-5 Colostrum Powder 7 oz. Intended Use: Dietary Supplement for People. (Some customers use this for their pets).Packagi...
Supplements·113 affected·Nov 25, 2025
High RiskFDA
Ferndale Laboratories, Inc.
Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive,...
Medical Devices·24,589 affected·Nov 25, 2025
High RiskFDA
Bell Industries Llc
Zen Cleanse Blend herbal tea; .95 oz (27g) pouch; 18 pouches/box UPC: 819005011504
Beverages·66 affected·Nov 24, 2025
High RiskFDA
Gimme Coffee, Inc.
Outer-packaging: gimme! brand Decaf de Agua coffee pods, Net Wt. 4.23 oz, UPC 051497457990, box of 10 pods Inner-packaging/pod packaging...
Beverages·252 affected·Nov 24, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotr...
Oral Drugs·7,389 affected·Nov 24, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotr...
Oral Drugs·3,397 affected·Nov 24, 2025
High RiskFDA
Smith & Nephew, Inc.
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Medical Devices·168 affected·Nov 24, 2025
High RiskFDA
Icu Medical, Inc.
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Medical Devices·7 affected·Nov 24, 2025
High RiskFDA
Zimmer Surgical Inc
Zimmer Air Dermatome, Model/Catalog Number: 00880100100
Medical Devices·839 affected·Nov 24, 2025
CriticalFDA
Draeger, Inc.
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
Medical Devices·431 affected·Nov 24, 2025
High RiskFDA
Icu Medical, Inc.
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Medical Devices·12 affected·Nov 24, 2025
CriticalFDA
Abbott Diabetes Care, Inc.
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 C...
Diabetes Devices·1,060,723 affected·Nov 24, 2025
CriticalFDA
Wegmans Food Markets, Inc.
Locatelli Pecorino Romano Cheese Grated (Wegmans #270010) Packaged and sold by the pound Packaged in cylindrical clear plastic tubs with ...
Dairy·2,773 affected·Nov 22, 2025
CriticalFDA
Gbc Food Services, Llc
EverRoast Chicken Caesar Salad 850042244142 Net Wt: 8.5 oz (255g)
Meat & Poultry·2 affected·Nov 22, 2025
CriticalFDA
Gbc Food Services, Llc
EverRoast Chicken Caesar Wrap 85004224455 Net Wt: 11.25 oz (303g)
Meat & Poultry·11 affected·Nov 22, 2025
High RiskFDA
Changchun Wancheng Bio-electron Co., Ltd.
Male Fertility Sperm Test for Home Use (Cassette)
Medical Devices·1,000 affected·Nov 22, 2025
High RiskFDA
Changchun Wancheng Bio-electron Co., Ltd.
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Medical Devices·4,800 affected·Nov 22, 2025
High RiskFDA
Changchun Wancheng Bio-electron Co., Ltd.
Vivoo Protein Test
Medical Devices·500 affected·Nov 22, 2025
High RiskFDA
Changchun Wancheng Bio-electron Co., Ltd.
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Rea...
Diagnostic Devices·91,366 affected·Nov 22, 2025
CriticalFDA
The Whole Herb Company, Inc.
SENNA LEAVES F/C OG Item No: SEN15001 Net Wt: 44.75 Lbs Distributed By Whole Herb Company 19800 8th Street East, Sonoma, CA 95476 UPC 100...
Food·3,580 affected·Nov 21, 2025
CriticalFDA
Lotus Mom Corporation Dba Indian Kitchen Mart
Brass Pital Pot 4-quart. Sticker label: BRASS HAMMERED HANDI NO 3 UPC 7 023672 414398 US $ 74.99 Sticker label: IKM INDIAN KITCHEN MART
Food·9 affected·Nov 21, 2025
CriticalFDA
Ambriola Co., Inc., The
Sam's Pecorino Romano grated, 1.5 lb Plastic Bags, 12 units per case
Food·1,015 affected·Nov 21, 2025
High RiskFDA
Lotus Mom Corporation Dba Indian Kitchen Mart
Aluminum Kadai with Metal Handles Size 5. A-Cook MADE IN INDIA SIZE 5 Sticker label: $$24.99+TX
Food·43 affected·Nov 21, 2025
CriticalFDA
Ambriola Co., Inc., The
Boar's Head Pecorino Romano Grated, 5-pound plastic bag (unit)
Food·405 affected·Nov 21, 2025
High RiskFDA
Sb Food Llc
Yoyo Gummy Grape Plus Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
Food·100 affected·Nov 21, 2025
High RiskFDA
Lotus Mom Corporation Dba Indian Kitchen Mart
IKM Aluminum Saucepan 9" with Wooden Handle. Sticker label: ALUMINIUM PAN 2 SIDE POUTED WOODEN HANDLE 9" UPC 7 023672 411878 US $ 17.99 ...
Food·56 affected·Nov 21, 2025
High RiskFDA
Lotus Mom Corporation Dba Indian Kitchen Mart
Brass Tope. Sticker label: $29.99+TAX
Food·10 affected·Nov 21, 2025
CriticalFDA
Silvestri Sweets Inc Dba Carousel Candies
Choceur Pecan Cranberry & Cinnamon Holiday Bark. Standup Pouch Bag. 5 oz. (142g). UPC: 4069365095829. Wholesale unit is split case, with ...
Produce·134,865 affected·Nov 21, 2025
CriticalFDA
Ambriola Co., Inc., The
Pinna Grated Pecorino Romano 2/10, 10-pound plastic bags (units)
Food·45 affected·Nov 21, 2025
High RiskFDA
Sb Food Llc
Yoyo Gummy Tropical Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
Food·100 affected·Nov 21, 2025
CriticalFDA
Silvestri Sweets Inc Dba Carousel Candies
Choceur Cookie Butter Holiday Bark. Standup Pouch Bag. 5 oz. (142g). UPC: 4069365095690. Wholesale unit is split case, with 9 of each ite...
Dairy·134,865 affected·Nov 21, 2025
CriticalFDA
Ambriola Co., Inc., The
Ambriola Piccante grated Pecorino Romano, 5 and 10-pound plastic bags (units)
Food·179 affected·Nov 21, 2025
High RiskFDA
Sb Food Llc
Yoyo Gummy Assorted Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
Food·100 affected·Nov 21, 2025
CriticalFDA
Ambriola Co., Inc., The
Locatelli Grated Pecorino Romano 4 oz and 8 oz plastic cup & lid, 12 units per case
Food·6,632 affected·Nov 21, 2025
CriticalFDA
Ambriola Co., Inc., The
Boar's Head Grated Pecorino Romano, 6 oz Plastic Cup & Lid, 12 units per case
Food·2,106 affected·Nov 21, 2025
CriticalFDA
Ambriola Co., Inc., The
Locatelli Grated Pecorino Romano, 5 and 10-pound plastic bags (units)
Food·964 affected·Nov 21, 2025