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

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

Clear
DateProductReasonClassFirm
Sep 23, 2024 KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40),... The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek s... Class II Pro-Dex Inc
Feb 15, 2023 KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), u... Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-... Class II Pro-Dex Inc
Feb 14, 2023 KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter... Incorrect Unique Device Identifier/GTIN code was used on product. Class II Pro-Dex Inc
Sep 25, 2018 PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, S... Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with s... Class II Pro-Dex Inc
Dec 23, 2015 Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power ... The sterile battery may contain particulates within the sterile package. Class II Pro-Dex Inc
Dec 23, 2015 Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS ... The sterile battery may contain particulates within the sterile package. Class II Pro-Dex Inc

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.