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High RiskFDA
Microtek Medical, Inc.
Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Dr...
Medical Devices·2,024 affected·Apr 13, 2025
High RiskFDA
Upper Crust Bakery Lp
Multigrain Sourdough , 18 oz, Paper carton (corrugated), CP12, Frozen
Frozen Food·699 affected·Apr 12, 2025
High RiskFDA
Giant Eagle, Inc.
Multigrain Sourdough Freshly Backed, and Half Multigrain Sourdough Artisan Bread, 15 oz; 7 oz, Bag, 1 unit
Bakery & Grains·240 affected·Apr 12, 2025
High RiskFDA
Upper Crust Bakery Lp
Ancient Grains Hoagie Roll, 4 oz, Paper carton (corrugated), CP45, Frozen
Frozen Food·89 affected·Apr 12, 2025
High RiskFDA
Upper Crust Bakery Lp
Whole Grain Multigrain , 20 oz, Paper carton (corrugated), CP12, Frozen
Frozen Food·30 affected·Apr 12, 2025
High RiskFDA
Dianne's Fine Desserts
Outer carton labeled: "Cookie Butter Banana Pie" Inner carton labeled: "Tropical Key Lime Pie" Product contained inside: "Cookie Butter ...
Dairy·1,191 affected·Apr 12, 2025
High RiskFDA
Emily Kate's Foods
Emily Kate's Gluten Free Vanilla Cake, Net Wt. 6.4oz, Emily Kate's Foods, Kansas City, KS 66106, UPC 850581007253
Bakery & Grains·1,140 affected·Apr 11, 2025
High RiskFDA
Emily Kate's Foods
Emily Kate's Gluten Free Carrot Cake, Net Wt. 6.4oz, Emily Kate's Food, LLC, Kansas City, KS 66106, UPC 850581007284
Bakery & Grains·1,140 affected·Apr 11, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617,...
Oral Drugs·4,885 affected·Apr 10, 2025
High RiskFDA
Eugia Us Llc
Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, M...
Injectable Drugs·36,816 affected·Apr 10, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, ...
Oral Drugs·18,984 affected·Apr 10, 2025
High RiskFDA
Lupin Pharmaceuticals Inc.
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 2...
Oral Drugs·2,724 affected·Apr 10, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, ...
Oral Drugs·4,872 affected·Apr 10, 2025
High RiskFDA
Accord Healthcare, Inc.
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617,...
Oral Drugs·4,888 affected·Apr 10, 2025
High RiskFDA
Tornier S.a.s.
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Surgical Devices·438 affected·Apr 10, 2025
High RiskFDA
Apipharma
Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distribu...
Topical Drugs·4,218 affected·Apr 9, 2025
High RiskFDA
Cardinal Health Inc.
Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose ...
Injectable Drugs·48 affected·Apr 9, 2025
High RiskFDA
Apipharma
Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10...
Topical Drugs·5,095 affected·Apr 9, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
Medical Devices·840 affected·Apr 9, 2025
High RiskFDA
Foundation Medicine, Inc.
FoundationOne Companion Diagnostic (F1CDx)
Diagnostic Devices·4 affected·Apr 9, 2025
High RiskFDA
Goodsource Solutions, Incorporated
Sauce, Creamy Butter; packaged in clear, unlabeled bulk 6-pound bags/4 bags to a case. Lot code# 701493 stamped on bag.
Dairy·1 affected·Apr 8, 2025
High RiskFDA
Inari Medical - Oak Canyon
Artix MT Thrombectomy Device, REF: 32-102
Medical Devices·45 affected·Apr 8, 2025
High RiskFDA
Beckman Coulter Inc.
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69...
Medical Devices·1,805 affected·Apr 8, 2025
High RiskFDA
Philips North America Llc
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm L...
Medical Devices·486,631 affected·Apr 7, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Medical Devices·996 affected·Apr 7, 2025
High RiskFDA
Science & Bio Materials
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Medical Devices·30 affected·Apr 7, 2025
High RiskFDA
The Hot Chocolatier - St. Elmo, Llc
Blueberry Lemon Scones, bulk packaged in bakery boxes. Products are sold at retail in pastry cases and not individually labeled.
Bakery & Grains·25 affected·Apr 4, 2025
High RiskFDA
All American Trading Of Houston, Inc.
Texas Olive Co. Pepperoncini 16 oz glass jars
Food·207 affected·Apr 4, 2025
High RiskFDA
All American Trading Of Houston, Inc.
Texas Olive Company Capers Capote 8 oz. plastic containers. All lots with expiry prior to 06/04/2025 Texas Olive Company Capers Capote ...
Food·3,124 affected·Apr 4, 2025
High RiskFDA
Request Foods Incorporated
Cuban-Style Black Bean Soup, 4 / 4lb pouches, Net Wt. 16lb
Food·7,864 affected·Apr 4, 2025
High RiskFDA
Request Foods Incorporated
Moroccan Style Lentil Soup, 4 x 8lb pouches, Net wt. 32lb
Food·2,094 affected·Apr 4, 2025
High RiskFDA
Vaughan Mills Packaging Ltd.
Giant, Instant Oatmeal Raisins and Spice, 10 -1.5 oz. Packets, per box. Net. Wt. 15.01 oz.
Food·1,350 affected·Apr 4, 2025
High RiskFDA
Request Foods Incorporated
Mexican Street Corn Soup, 4 / 4lb pouches, Net Wt. 16lb
Food·7,388 affected·Apr 4, 2025
High RiskFDA
All American Trading Of Houston, Inc.
Texas Olive Company Giardiniera 16 oz. glass jars All lots with expiry prior to 06/14/2025
Food·811 affected·Apr 4, 2025
High RiskFDA
Integra Lifesciences Corp. (neurosciences)
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Surgical Devices·6 affected·Apr 4, 2025
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PL...
Surgical Devices·189 affected·Apr 4, 2025
High RiskFDA
Klinika Mdical Gmb
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical devic...
Surgical Devices·160 affected·Apr 4, 2025
High RiskFDA
Supherb Farms
Label: FROZEN CHOPPED CILANTRO; PACK SIZE: 4 - 8 oz; NET WT: 2 lb; PERISHABLE - KEEP FROZEN; Packaging: 4 - 8 oz ziploc plastic bags in ...
Frozen Food·572 affected·Apr 3, 2025
High RiskFDA
Valley Fine Foods Co., Inc
CHILE VERDE EGG BITES; NET WT. 4.6 OZ (130 g); 2 egg bites/package
Food·646 affected·Apr 3, 2025
High RiskFDA
Gordon Desserts Dba Mochidoki
Sundae Shoppe, Cookies and Cream Mochi Ice Cream, 6 count, 7.5 oz, Plastic sealed tray inside paper carton. 6 Pieces per carton, 8 carto...
Dairy·5,016 affected·Apr 3, 2025
High RiskFDA
Supherb Farms
Label: IQF CILANTRO LARGE; NET WT: 30LB; PERISHABLE KEEP FROZEN; Packaging: blue plastic liner inside brown cardboard box
Frozen Food·96,000 affected·Apr 3, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Di...
Oral Drugs·3,144 affected·Apr 3, 2025
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. ...
Medical Devices·908 affected·Apr 3, 2025
High RiskFDA
Wandercraft Sas
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabili...
Medical Devices·3 affected·Apr 3, 2025
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 -...
Medical Devices·1,771 affected·Apr 3, 2025
High RiskFDA
Medtronic Neuromodulation
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Medical Devices·534 affected·Apr 3, 2025
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2...
Medical Devices·1,180 affected·Apr 3, 2025
High RiskFDA
Amerisource Health Services Llc
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, ...
Injectable Drugs·14,189 affected·Apr 2, 2025