Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 9 FDA device recalls.

Clear
DateProductReasonClassFirm
Mar 15, 2024 Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang... Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas. Class II Alcon Research, LLC
Feb 21, 2024 SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pa... Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be br... Class II Alcon Research, LLC
Sep 7, 2023 Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARAC... Custom surgical procedure packs contain latex gloves but are labeled as "latex free". Class II Alcon Research, LLC
Aug 18, 2023 Constellation Vision System, REF: 8065751150 Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could ... Class II Alcon Research, LLC
Mar 10, 2023 Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 175... Sterility; Steril surgical procedure packs contain incomplete seals. Class II Alcon Research, LLC
Oct 31, 2022 Alcon Custom Pak Surgical Procedure Pack Due to difficulty removing the liner on the adhesive components of the affected drapes and as a r... Class II Alcon Research, LLC
Jun 9, 2022 Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 P... Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves. Class II Alcon Research, LLC
Feb 2, 2021 Alcon Custom Ophthalmic Surgical Procedure Packs Reports have been received concerning mold found on gowns included in custom ophthalmic surgery ... Class II Alcon Research, LLC
Aug 24, 2020 Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXI... The third-party brand latex micro surgical gloves packaged within specific custom packs may have ... Class II Alcon Research, LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.