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
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010
Surgical Devices2,321 affectedSep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010
Surgical Devices2,321 affectedSep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010
Surgical Devices2,321 affectedSep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005
Surgical Devices2,321 affectedSep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
Surgical Devices2,321 affectedSep 11, 2023
High RiskFDA
Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005
Surgical Devices2,321 affectedSep 11, 2023
High RiskFDA
Lipari Foods Operating Company, Llc.
IO Inspired Organics Organic Raw Walnuts, 5oz bag, UPC 8 63669 74200 7, 9 bags per wholesale case
Food17 affectedSep 9, 2023
CriticalFDA
Church & Dwight Inc
TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 970...
Oral Drugs5,316 affectedSep 8, 2023
CriticalFDA
Novartis Pharmaceuticals Corp.
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., ...
Oral Drugs1,272 affectedSep 8, 2023
High RiskFDA
Ge Healthcare
Universal Viewer Workflow Manager, Image processing radiological system
Medical Devices57 affectedSep 8, 2023
High RiskFDA
Ge Medical Systems China Co., Ltd.
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Medical Devices1,638 affectedSep 8, 2023
High RiskFDA
Omega Medical Imaging, Inc.
Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
Medical Devices31 affectedSep 8, 2023
RecallFDA
Sun Pharmaceutical Industries Inc
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactur...
Ophthalmic Drugs69,707 affectedSep 7, 2023
High RiskFDA
Edwards Lifesciences, Llc
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Surgical Devices185 affectedSep 7, 2023
High RiskFDA
Blue Belt Technologies, Inc
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Medical Devices56 affectedSep 7, 2023
High RiskFDA
Lipari Foods Operating Company, Llc.
JLM Roasted Salted Pecan Halves, 10oz clear plastic container, 12 per wholesale case. Lipari number 368729, UPC 094776110049
Food98 affectedSep 6, 2023
CriticalFDA
Fresh Unlimited Inc
Freshway Foods - Diced Butternut Squash, packaged in 4 pound plastic bags - 4 bags per case.
Dairy1,888 affectedSep 6, 2023
High RiskFDA
Ge Medical Systems, Israel Ltd.
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imagi...
Medical Devices5,986 affectedSep 6, 2023
High RiskFDA
Encore Medical, Lp
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Surgical Devices146 affectedSep 6, 2023
High RiskFDA
Randox Laboratories Ltd.
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
Medical Devices0 affectedSep 6, 2023
CriticalFDA
Fresenius Medical Care Holdings, Inc.
2008T HD SYS. W/O CDX BLUESTAR
Medical Devices733 affectedSep 6, 2023
CriticalFDA
Fresenius Medical Care Holdings, Inc.
2008T Hemodialysis SYS, with CDX
Medical Devices703 affectedSep 6, 2023
High RiskFDA
Randox Laboratories Ltd.
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
Medical Devices13 affectedSep 6, 2023
High RiskFDA
Smiths Medical Asd Inc.
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Medical Devices31,900 affectedSep 6, 2023
High RiskFDA
Randox Laboratories Ltd.
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
Medical Devices35 affectedSep 6, 2023
CriticalFDA
Fresenius Medical Care Holdings, Inc.
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Medical Devices733 affectedSep 6, 2023
RecallFDA
Slr Food Distribution, Inc.
Dried Longans
Food18 affectedSep 5, 2023
CriticalFDA
Obc Group Corp
LA ORIGINAL - THE ORIGINAL, NUT DIET MAX, Nuez de la India
Food0 affectedSep 5, 2023
CriticalFDA
Life Raft Treats Ice Cream Factory
Life Raft TREATS LIFE IS PEACHY NET WT. 15 OZ BOX HAND CRAFTED IN CHARLESTON, SC
Food240 affectedSep 5, 2023
Medium RiskFDA
Vi-jon, Llc
Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0....
Drugs245,904 affectedSep 5, 2023
High RiskFDA
Be Pharmaceuticals Ag
Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-1...
Injectable Drugs41,148 affectedSep 5, 2023
High RiskFDA
Mazor Robotics Ltd
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Medical Devices324 affectedSep 5, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Medical Devices0 affectedSep 5, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Medical Devices0 affectedSep 5, 2023
CriticalFDA
Sheng Kee Of California, Inc Dba Sheng Kee Bakery
Large 4- Red Bean Mooncake Gift Box
Bakery & Grains0 affectedSep 1, 2023
CriticalFDA
Sheng Kee Of California, Inc Dba Sheng Kee Bakery
Large 4- Lotus Pine Nut Mooncake Gift Box
Bakery & Grains0 affectedSep 1, 2023
CriticalFDA
Sheng Kee Of California, Inc Dba Sheng Kee Bakery
Small 12 -3 Flavor Assorted Mooncake Gift Box Small 12- 4 Flavor Assorted Mooncake Gift Box Small 12- 6 Flavor Assorted Mooncake Tin Gift...
Bakery & Grains0 affectedSep 1, 2023
CriticalFDA
Censea Inc
Central Seafoods 30# case of IQF whole octopus. Three item codes / GTIN numbers depending on size of individual octopus: Item 10400: 2...
Seafood281 affectedSep 1, 2023
CriticalFDA
Sheng Kee Of California, Inc Dba Sheng Kee Bakery
Large 4- Date Mooncake Gift Box
Bakery & Grains0 affectedSep 1, 2023
CriticalFDA
Sheng Kee Of California, Inc Dba Sheng Kee Bakery
Small 12- Tea Flavor Assorted Mooncake Gift Box
Bakery & Grains0 affectedSep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Com...
Ophthalmic Drugs8,747 affectedSep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceutica...
Ophthalmic Drugs30,490 affectedSep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Compa...
Ophthalmic Drugs196,442 affectedSep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company...
Ophthalmic Drugs18,171 affectedSep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Compan...
Ophthalmic Drugs8,747 affectedSep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Compa...
Ophthalmic Drugs8,000 affectedSep 1, 2023
RecallFDA
Amerisource Health Services Llc
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Colu...
Oral Drugs3,344 affectedSep 1, 2023
High RiskFDA
Amman Pharmaceutical Industries
TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Compa...
Ophthalmic Drugs8,810 affectedSep 1, 2023