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
CriticalFDA
Sleepnet Corporation
Mojo Non Vented Full Face Mask with Headgear, All Sizes
Medical Devices·11,874 affected·Mar 1, 2024
High RiskFDA
Pacific Lasertech, Llc
25-LHP-828, HeNe Laser System, 35 mW
Medical Devices·4 affected·Mar 1, 2024
High RiskFDA
Cook Incorporated
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-va...
Surgical Devices·4,856 affected·Mar 1, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-freque...
Surgical Devices·2,525 affected·Mar 1, 2024
High RiskFDA
Vitony Bakery, Inc.
Vitony Bakery, Bizcocho de Queso y Guayaba (cheese-guava cake), PESO NETO 14oz (397g) (12 (14 oz) packages per case)
Dairy·6,706 affected·Feb 29, 2024
High RiskFDA
Aji Mori Sauce Corp
AJI MORI***CHILLIMAMI SAUCE***UMAMI BOMB***NET WT. 250ml. Packaged in a LDPE bottle. Refrigerate after opening.
Food·78 affected·Feb 29, 2024
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded D...
Injectable Drugs·11,798 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 2...
Ophthalmic Drugs·24,216 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi ...
Ophthalmic Drugs·30,240 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi L...
Ophthalmic Drugs·19,344 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite #...
Ophthalmic Drugs·10,536 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lan...
Ophthalmic Drugs·106,704 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite...
Ophthalmic Drugs·9,936 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Ren...
Ophthalmic Drugs·7,248 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi La...
Ophthalmic Drugs·139,656 affected·Feb 29, 2024
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Offi...
Injectable Drugs·140 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 20...
Ophthalmic Drugs·47,832 affected·Feb 29, 2024
High RiskFDA
Optikem International, Inc.
hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Ri...
Ophthalmic Drugs·46,621 affected·Feb 29, 2024
High RiskFDA
Covidien, Lp
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
Medical Devices·165,356 affected·Feb 28, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
Medical Devices·9,549 affected·Feb 28, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
Medical Devices·2,413 affected·Feb 28, 2024
High RiskFDA
Seaspine Orthopedics Corporation
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle...
Medical Implants·444 affected·Feb 28, 2024
High RiskFDA
Covidien, Lp
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
Medical Devices·93,673 affected·Feb 28, 2024
High RiskFDA
Covidien, Lp
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
Medical Devices·11,796 affected·Feb 28, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
Medical Devices·9,899 affected·Feb 28, 2024
High RiskFDA
Philips North America
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
Medical Devices·2,323 affected·Feb 28, 2024
High RiskFDA
Philips North America
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Versi...
Medical Devices·257,183 affected·Feb 28, 2024
High RiskFDA
Covidien, Lp
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
Medical Devices·44,777 affected·Feb 28, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
Medical Devices·4,774 affected·Feb 28, 2024
High RiskFDA
The Coca-cola Company
Powerade Mountain Berry Blast - 20oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the variety pack
Produce·366 affected·Feb 27, 2024
High RiskFDA
The Coca-cola Company
Powerade Zero Fruit Punch - 20oz PET bottles 24 variety pack, 8 bottles of Powerade Grape within the variety pack
Produce·149 affected·Feb 27, 2024
CriticalFDA
Roland Foods, Llc.
Roland Tahini; 100% Ground Sesame Seeds; Net WT. 16 OZ. (1 LB.) 454g
Food·0 affected·Feb 27, 2024
High RiskFDA
Karl Storz Endoscopy
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Medical Devices·27 affected·Feb 27, 2024
CriticalFDA
Smiths Medical Asd Inc.
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arteri...
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-1...
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
Medical Devices·45 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
Medical Devices·3 affected·Feb 27, 2024
High RiskFDA
Convatec, Inc
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package,...
Medical Devices·63 affected·Feb 27, 2024
High RiskFDA
Karl Storz Endoscopy
Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
Medical Devices·147 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Ortho-clinical Diagnostics
VITROS Performance Verifier I
Medical Devices·10,911 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
Medical Devices·48 affected·Feb 27, 2024
High RiskFDA
Karl Storz Endoscopy
Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
Surgical Devices·190 affected·Feb 27, 2024
High RiskFDA
Howmedica Osteonics Corp.
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
Medical Devices·0 affected·Feb 27, 2024
High RiskFDA
Emergency Products & Research
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Medical Devices·190,000 affected·Feb 27, 2024