Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 27901–27920 of 38,428 recalls
Recalled Item: BD SurePathTM Preservative Collection Vials
The Issue: BD has confirmed that a portion of BD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instinct¿ Java¿ System (IFU : 046WAN0000T) . Stabilizes one or
The Issue: Zimmer Biomet is initiating a Medical Device Correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Universal Clamp¿ System (IFU : SNA027-N-90001). Provides the stability required
The Issue: Zimmer Biomet is initiating a Medical Device Correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris PC Unit
The Issue: CareFusion is recalling the Alaris PC unit because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Helioseal Clear 1 x 1.25 g
The Issue: Complaints were received claiming the material failed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mammomat Inspiration with Tomosynthesis functionality
The Issue: A potential system fatal error may occur during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter.
The Issue: Product may kink during use rendering the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KAMRA Inlay
The Issue: AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan LabPro Information Manager System
The Issue: Beckman Coulter is recalling the MicroScan LabPro Information
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accu-Chek Inform II Base Unit as a part of the
The Issue: Accu-Chek Inform II Base Unit might produce physical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: M/L Taper Hip Prosthesis (Item: 00-7711-012-20
The Issue: Zimmer Biomet initiated a lot-specific voluntary recall on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation Therapy Treatment Planning System Stand-alone Software 3.0
The Issue: A software issue with editing tools that use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: evaluemed Infant Heel Warmer 301-1223
The Issue: eValueMed Infant Heel Warmers and eValueMed Infant Transport
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: eValueMed Infant Transport Mattress 301-1015
The Issue: eValueMed Infant Heel Warmers and eValueMed Infant Transport
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451
The Issue: Focus Diagnostics is recalling the Direct Amplification Discs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451
The Issue: Focus Diagnostics is recalling the Direct Amplification Discs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451
The Issue: Focus Diagnostics is recalling the Direct Amplification Discs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ambu
The Issue: Ambu, Aura Gain laryngeal Mask, was found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intra operative MRI Systems: Neuro II-SE
The Issue: Emergency helium venting lines (i.e. quench lines) may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.