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 2161–2180 of 38,428 recalls
Recalled Item: Baxter Novum IQ Syringe Pump
The Issue: Baxter has identified a design issue which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP
The Issue: Sterile, single use closed system drug transfer devices,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium
The Issue: Sterile, single use closed system drug transfer devices,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Texium: 3 mL
The Issue: Sterile, single use closed system drug transfer devices,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for
The Issue: This device does not indicate for use in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS
The Issue: a software anomaly allows test results to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support
The Issue: This device does not indicate for use in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in
The Issue: This device does not indicate for use in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog
The Issue: a software anomaly allows test results to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog
The Issue: A software anomaly allows test results to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model: Description/: MNA-420 ENC -H/K9303320
The Issue: Cathode ray tube display system encoders and decoders
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope
The Issue: The replacement rechargeable batteries inserted into the Welch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis Product Name / UDI-DI code / Catalog No.
The Issue: Antivirus software was not consistently installed on impacted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name [REF]: Supply Server
The Issue: During automated dispensing cabinet upgrade/installation/reimaging, component ma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GCE HEALTHCARE Zen-O lite
The Issue: Erroneous calibration values, potentially resulting in: as the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prestige Coil System /UDI-DI codes: PRES0153CXPPLT 00810068567311...
The Issue: Due to radiopaque (RO) marker was not visible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima Coil System /UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK...
The Issue: Due to radiopaque (RO) marker was not visible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic
The Issue: The device cap label may not adhere to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Valeda Light Delivery System Product Name: Light Based
The Issue: U.S. customers were shipped devices that were configured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 9000 Access Immunoassay Analyzer C11137
The Issue: Analyzer has calibration issues where curves switched from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.