Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
High RiskFDA
Boston Scientific Corporation
AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended f...
Medical Implants·6 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining...
Medical Implants·133 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining eso...
Medical Implants·507 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining...
Medical Implants·79 affected·Aug 1, 2024
High RiskFDA
Becton Dickinson & Co.
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically signif...
Medical Devices·4,295 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esop...
Medical Implants·516 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining...
Medical Implants·308 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaini...
Medical Implants·79 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaini...
Medical Implants·145 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for...
Medical Implants·7 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaini...
Medical Implants·146 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining...
Medical Implants·39 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintainin...
Medical Implants·66 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining...
Medical Implants·305 affected·Aug 1, 2024
High RiskFDA
Becton Dickinson & Co.
BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacter...
Medical Devices·764 affected·Aug 1, 2024
High RiskFDA
Outset Medical, Inc.
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in ...
Medical Devices·2,422 affected·Aug 1, 2024
CriticalFDA
Fresenius Kabi Usa, Llc
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous in...
Medical Devices·180 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for...
Medical Implants·18 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintainin...
Medical Implants·2 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining eso...
Medical Implants·364 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for main...
Medical Implants·124 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maint...
Medical Implants·231 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintain...
Medical Implants·77 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining...
Medical Implants·199 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended f...
Medical Implants·6 affected·Aug 1, 2024
High RiskFDA
Boston Scientific Corporation
WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaini...
Medical Implants·115 affected·Aug 1, 2024
CriticalFDA
Metro Produce Distributors, Inc.
Lunds & Byerlys Fresh Guacamole Dip, Net Wt 14 oz (396g). UPC 0 72431-66072 6. Keep Refrigerated.
Food·572 affected·Jul 31, 2024
CriticalFDA
Metro Produce Distributors, Inc.
Lunds & Byerlys Spicy Guacamole Dip, Net Wt 10 oz (283g). UPC 0 72431-66128 0. Keep Refrigerated.
Food·121 affected·Jul 31, 2024
CriticalFDA
Metro Produce Distributors, Inc.
Lunds & Byerlys Deli Guacamole, Item 85999. Net Wt 56 oz. Keep Refrigerated.
Food·28 affected·Jul 31, 2024
CriticalFDA
Metro Produce Distributors, Inc.
Lunds & Byerlys Smokin' Guacamole Dip, Net Wt 10 oz (283g). UPC 0 72431-66130 3. Keep Refrigerated.
Food·78 affected·Jul 31, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-...
Oral Drugs·2,404 affected·Jul 31, 2024
High RiskFDA
Granules Pharmaceuticals Inc.
Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactur...
Oral Drugs·11,808 affected·Jul 31, 2024
CriticalFDA
Medtronic Minimed, Inc.
MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MM...
Diabetes Devices·234,360 affected·Jul 31, 2024
High RiskFDA
Inspire Medical Systems Inc.
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Respiratory Devices·152 affected·Jul 31, 2024
High RiskFDA
Beckman Coulter Inc.
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemist...
Diagnostic Devices·12,102 affected·Jul 31, 2024
High RiskFDA
Coopersurgical, Inc.
Stainless Steel Sims Uterine Sound, Part Number 64-601
Medical Devices·657 affected·Jul 31, 2024
High RiskFDA
Wr Coffee Inc
Ham and Cheese Croissant (approximately 6.5 oz) delivered fresh in bins to the firm's Restaurants- no label. Not individually packaged.
Dairy·90 affected·Jul 30, 2024
CriticalFDA
Publix Super Markets, Inc.
Boars Head Grab and Go Wedge Ham, Smoke Master Black Forest Ham, Grab and Go Sandwich, NET WT. 7.5 OZ (213 g), Plastic Container, KEEP RE...
Food·2,786 affected·Jul 30, 2024
High RiskFDA
Colonna Brothers Inc.
Ground cinnamon. Supreme Tradition brand ground cinnamon packaged in 2.25 oz clear plastics jars with black lids. UPC: 639277656377 Ma...
Food·0 affected·Jul 30, 2024
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Diagnostic Devices·5,371 affected·Jul 30, 2024
High RiskFDA
El Chilar-hf, Llc
El Chilar, Canela Molida, Ground Cinnamon NET WT. 1.25 Oz (35g) , Spices Herbs, BOPP Bag, 12 units per cases
Food·54 affected·Jul 29, 2024
High RiskFDA
La Superior Bakery
La Superior Bakery - Pan De Rancho packaged in clear plastic bag - 5 pastries per bag
Food·11 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 41303.82013, Reser's Essential Everyday Original Potato Salad, refrigerated product, net wt. 16oz. There are 6 packs per case.
Produce·50 affected·Jul 29, 2024
High RiskFDA
La Superior Bakery
La Superior Bakery - Pan Guatemalteco packaged in clear plastic bag - 5 pastries per bag
Food·5 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.14459, Gravy Homestyle, refrigerated product, net wt. 4lb. There are 3 packs per case.
Food·144 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.02123, Reser's American Classics Macaroni & Cheese, refrigerated product, net wt. 12oz. There are 6 packs per case.
Dairy·18 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.15207, Reser's Raspberry Parfait Desserts, refrigerated product, net wt. 8lb. There are 2 packs per case.
Produce·18 affected·Jul 29, 2024
High RiskFDA
Reser's Fine Foods, Inc.
Item 71117.03034, Reser's Kit HF Pudding Banana, refrigerated product, net wt. 4.81lb. There are 2 packs per case.
Food·6 affected·Jul 29, 2024