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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Jun 16, 2025 BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (... Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the... Class II BD SWITZERLAND SARL
May 12, 2025 BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010... Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... Class II BD SWITZERLAND SARL
May 12, 2025 Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With... Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... Class II BD SWITZERLAND SARL
May 12, 2025 BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China)... Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... Class II BD SWITZERLAND SARL
May 12, 2025 BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, R... Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... Class II BD SWITZERLAND SARL
May 12, 2025 BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500 Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded... Class II BD SWITZERLAND SARL
Feb 20, 2025 BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Conne... Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instr... Class II BD SWITZERLAND SARL
Apr 18, 2024 Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 Sma... Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing del... Class II BD SWITZERLAND SARL
Apr 9, 2020 BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identificatio... The products have the potential to leak between the connection of the male luer and the yellow st... Class II BD SWITZERLAND SARL
Apr 9, 2020 BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identificatio... The products have the potential to leak between the connection of the male luer and the yellow st... Class II BD SWITZERLAND SARL
Apr 9, 2020 BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identificatio... The products have the potential to leak between the connection of the male luer and the yellow st... Class II BD SWITZERLAND SARL

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.