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
www.fda.gov →Official Site

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68,659 recalls
High RiskFDA
Radiometer Medical Aps
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole bl...
Medical Devices·27,127 affected·May 31, 2024
High RiskFDA
Stryker Sustainability Solutions
REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Medical Devices·90 affected·May 31, 2024
High RiskFDA
Maquet Cardiovascular, Llc
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. Th...
Medical Devices·600 affected·May 31, 2024
High RiskFDA
Avanos Medical, Inc.
MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* ...
Medical Devices·53,384 affected·May 31, 2024
CriticalFDA
Siemens Medical Solutions Usa, Inc
AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in o...
Medical Devices·2 affected·May 31, 2024
CriticalFDA
Smiths Medical Asd Inc.
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
Respiratory Devices·10,240 affected·May 31, 2024
CriticalFDA
Siemens Medical Solutions Usa, Inc
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix P...
Medical Devices·3 affected·May 31, 2024
High RiskFDA
Olympus Corporation Of The Americas
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Medical Devices·1,585 affected·May 31, 2024
CriticalFDA
Smiths Medical Asd Inc.
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
Respiratory Devices·11,244 affected·May 31, 2024
CriticalFDA
Abiomed, Inc.
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Cardiac Devices·9 affected·May 31, 2024
High RiskFDA
Heinens
Heinen's Tuscan Salad Bowl Ingredients: Garbanzo Beans***Disodium EDTA***Arugula, Roasted Corn***Red Bell Pepper, Dried Cranberries***Wal...
Dairy·106 affected·May 30, 2024
High RiskFDA
Tillamook County Creamery Association
Tillamook Colby Jack/Monterey Jack Cheese Slices, item # 651195, net wt. 32oz, total 42 slices per package, refrigerated, packaged in fle...
Dairy·1,149 affected·May 30, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceutic...
Oral Drugs·3,552 affected·May 30, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceutical...
Oral Drugs·0 affected·May 30, 2024
CriticalFDA
Glenmark Pharmaceuticals Inc., Usa
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceutical...
Oral Drugs·36,630 affected·May 30, 2024
CriticalFDA
Glenmark Pharmaceuticals Inc., Usa
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceutical...
Oral Drugs·285,840 affected·May 30, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceutical...
Oral Drugs·0 affected·May 30, 2024
CriticalFDA
Baxter Healthcare Corporation
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positi...
Medical Devices·58,220 affected·May 30, 2024
High RiskFDA
Dental Ez Group Star Dental Division
Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fi...
Medical Devices·32 affected·May 30, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Numb...
Medical Devices·0 affected·May 29, 2024
High RiskFDA
Getinge Usa Sales Inc
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4
Medical Devices·73 affected·May 29, 2024
High RiskFDA
Cardinal Health 200, Llc
Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit, Cat...
Cardiac Devices·17,445 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOM...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT N...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code ...
Medical Devices·0 affected·May 29, 2024
High RiskFDA
Getinge Usa Sales Inc
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
Medical Devices·7 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item C...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number...
Medical Devices·0 affected·May 29, 2024
High RiskFDA
Getinge Usa Sales Inc
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5
Medical Devices·171 affected·May 29, 2024
High RiskFDA
Cardinal Health 200, Llc
Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1...
Medical Devices·13,487 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Nu...
Medical Devices·0 affected·May 29, 2024
High RiskFDA
Integra Lifesciences Corp.
CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of ...
Surgical Devices·2 affected·May 29, 2024
CriticalFDA
Baxter Healthcare Corporation
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20...
Respiratory Devices·2,510 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONAT...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Nu...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) ...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Co...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
Medical Devices·3,138 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 6...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750...
Medical Devices·25,283 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code ...
Medical Devices·36,219 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) ...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Numb...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Ite...
Medical Devices·0 affected·May 29, 2024
High RiskFDA
American Spice Llc
Spice Class brand Ground Cinnamon packed in 7oz and 11oz PET jars
Food·1,224 affected·May 28, 2024
CriticalFDA
U.b.c. Food Distributors Inc.
Baraka brand ground black pepper packaged in 7oz retail containers with UPC 8 22514 26626 6; 10 units per case
Food·1,070 affected·May 28, 2024