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

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

Clear
DateProductReasonClassFirm
Jun 14, 2023 Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct A... There is a potential for the direct amplification disc to malfunction which may result in spilla... Class II DiaSorin Molecular LLC
Jan 30, 2023 Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix RE... Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause cont... Class II DiaSorin Molecular LLC
Jan 30, 2023 Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150;... Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause cont... Class II DiaSorin Molecular LLC
Nov 19, 2021 Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 A subset of affected discs are at risk of leakage when it is used more than one time with Simplex... Class II DiaSorin Molecular LLC
Sep 23, 2021 SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01)... Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is th... Class II DiaSorin Molecular LLC
May 12, 2020 MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAIS... Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occ... Class II DiaSorin Molecular LLC
May 12, 2020 MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous... Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occ... Class II DiaSorin Molecular LLC
May 12, 2020 MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the ... Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occ... Class II DiaSorin Molecular 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.