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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How to report to FDA →68,659 recalls
High RiskFDA
Medline Industries, Lp - Northfield
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
Medical Devices18 affectedSep 7, 2022
High RiskFDA
Balt Usa, Llc
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Medical Devices41 affectedSep 7, 2022
CriticalFDA
Philips Respironics, Inc.
Wisp and Wisp Youth Nasal Mask
Medical Devices6,237,558 affectedSep 6, 2022
CriticalFDA
Philips Respironics, Inc.
DreamWisp Nasal Mask with Over the Nose Cushion
Medical Devices930,813 affectedSep 6, 2022
CriticalFDA
Philips Respironics, Inc.
Philips Respironics Amara View Minimal Contact Full-Face Mask
Medical Devices5,661,639 affectedSep 6, 2022
High RiskFDA
Philips North America Llc
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Medical Devices115 affectedSep 6, 2022
RecallFDA
Baxter Healthcare Corporation
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starlin...
Medical Devices9,671 affectedSep 2, 2022
High RiskFDA
Luminostics, Inc Dba Clip Health
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
Diagnostic Devices10,037 affectedSep 2, 2022
High RiskFDA
Superior Glove Works, Ltd.
Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and water are ...
Topical Drugs7,296 affectedSep 1, 2022
High RiskFDA
B Braun Medical Inc
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Medical Devices94,000 affectedSep 1, 2022
High RiskFDA
Texas Medical Technology Inc.
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Surgical Devices100,000 affectedSep 1, 2022
High RiskFDA
Medline Industries, Lp - Northfield
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Medical Devices1,760 affectedSep 1, 2022
High RiskFDA
Johnson & Johnson Surgical Vision, Inc.
Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
Medical Devices53,624 affectedSep 1, 2022
High RiskFDA
Omm Imports, Inc. Dba Zero Gravity
Recreo Hair Growth Laser Comb
Medical Devices1,620 affectedSep 1, 2022
High RiskFDA
Akorn, Inc.
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
Drugs82,689 affectedAug 31, 2022
High RiskFDA
Akorn, Inc.
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478...
Topical Drugs48,636 affectedAug 31, 2022
High RiskFDA
Micro-x Ltd.
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Medical Devices42 affectedAug 31, 2022
High RiskFDA
Full Vision Inc
FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929
Medical Devices3 affectedAug 31, 2022
High RiskFDA
Full Vision Inc
FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927
Medical Devices38 affectedAug 31, 2022
High RiskFDA
Full Vision Inc
FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST1 110V, Model #317-07926GE
Medical Devices69 affectedAug 31, 2022
RecallFDA
Woodbine Products Co Inc
Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL (42 fl oz.), Manufactured for: Triple S, 800-3...
Drugs595 affectedAug 30, 2022
High RiskFDA
Philips Medical Systems (cleveland) Inc
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Medical Devices169 affectedAug 30, 2022
High RiskFDA
Siemens Healthcare Diagnostics Inc
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
Medical Devices373 affectedAug 30, 2022
High RiskFDA
Siemens Healthcare Diagnostics Inc
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Medical Devices10,201 affectedAug 30, 2022
RecallFDA
Xiumin Lin
Haiyue Food Nutritional Preserved Vegetable
Produce55 affectedAug 29, 2022
High RiskFDA
Albertsons Companies Llc
Ready Meals Snow Crab Legs Imitation Surimi SCE NET WT 12 OZ CAL 300 NET WT. 0lb 12oz (340g) ready2eat Ingredients: Fish Protein (one o...
Meat & Poultry0 affectedAug 29, 2022
CriticalFDA
Albertsons Companies Llc
Ready Meals Shrimp Cooked with Cocktail Sauce SCE NET WT 12 OZ CAL 330 NET WT. 0lb 12oz (340g) ready2eat Ingredients: Shrimp (Litopenaues...
Seafood0 affectedAug 29, 2022
CriticalFDA
Best Nutritionals Llc
White plastic bottle with green, gold, and blue labeling containing 360, 610mg hard gelatin capsules of Fenugreek seed powder, labeled in...
Supplements3,580 affectedAug 29, 2022
High RiskFDA
Teva Pharmaceuticals Usa Inc
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single E...
Oral Drugs83,703 affectedAug 29, 2022
CriticalFDA
Teleflex Llc
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
Medical Devices164 affectedAug 29, 2022
CriticalFDA
Teleflex Llc
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medica...
Medical Devices355 affectedAug 29, 2022
CriticalFDA
Teleflex Llc
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in bre...
Medical Devices60,500 affectedAug 29, 2022
CriticalFDA
Teleflex Llc
Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
Surgical Devices12 affectedAug 29, 2022
CriticalFDA
St. James Smokehouse, Inc.
St. James Smokehouse, Scotch Reserve, Scottish Smoked Salmon, Net Wt 4oz (114g)
Seafood11,141 affectedAug 26, 2022
High RiskFDA
Carolina Infusion
MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs4 affectedAug 26, 2022
High RiskFDA
Carolina Infusion
TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs348 affectedAug 26, 2022
High RiskFDA
Carolina Infusion
QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs1 affectedAug 26, 2022
High RiskFDA
Carolina Infusion
Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs4 affectedAug 26, 2022
High RiskFDA
Carolina Infusion
TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs2 affectedAug 26, 2022
High RiskFDA
Carolina Infusion
MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs3 affectedAug 26, 2022
High RiskFDA
Carolina Infusion
TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs3 affectedAug 26, 2022
High RiskFDA
Carolina Infusion
Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs8 affectedAug 26, 2022
High RiskFDA
Carolina Infusion
TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs2 affectedAug 26, 2022
High RiskFDA
Carolina Infusion
Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs24 affectedAug 26, 2022
High RiskFDA
Carolina Infusion
TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland...
Injectable Drugs3 affectedAug 26, 2022
High RiskFDA
Carolina Infusion
TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs16 affectedAug 26, 2022
High RiskFDA
Carolina Infusion
TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs1 affectedAug 26, 2022
High RiskFDA
Carolina Infusion
TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Injectable Drugs1 affectedAug 26, 2022