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 37321–37340 of 38,428 recalls
Recalled Item: AquaLiner Hydrophilic Guidewire 0.035" X 260cm
The Issue: Nipro Medical Corporation, Miami, FL recalled their AquaLiner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AquaLiner Hydrophilic Guidewire 0.035" X 260cm
The Issue: Nipro Medical Corporation, Miami, FL recalled their AquaLiner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AquaLiner Hydrophilic Guidewire 0.035" X 180cm
The Issue: Nipro Medical Corporation, Miami, FL recalled their AquaLiner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AquaLiner Hydrophilic Guidewire 0.035" X 260cm
The Issue: Nipro Medical Corporation, Miami, FL recalled their AquaLiner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AquaLiner Hydrophilic Guidewire 0.035" X 260cm
The Issue: Nipro Medical Corporation, Miami, FL recalled their AquaLiner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multileaf Collimator To be used for single or multiple fractions
The Issue: Information released with the product Agility did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with
The Issue: An investigation of customer complaints identified that for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with
The Issue: An investigation of customer complaints identified that for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic
The Issue: Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TxRx Knee 15 Coil 3T. For use in conjunction with
The Issue: On July 27, 2012, it was reported to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxford Gap Gauge SML 3/4mm. The instrument is used for
The Issue: A drafting error during an unrelated design change
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting
The Issue: Content entered into the "Conclusions" free text box
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Eon Mini - 3788 (IPG)
The Issue: As part of St. Jude Medical's routine tracking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product
The Issue: St. Jude Medical has informed your doctor that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Eon Mini - 3721 (Charger). Product Usage: Eon Mini system
The Issue: St. Jude Medical has informed your doctor that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured...
The Issue: Philips determined that it is important to clarify
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model
The Issue: Philips determined that it is important to clarify
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Styker Orthobiologics Vita Plasma Separator
The Issue: When preparing plasma using VitaPrep, it was reported
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Serial interface module RS-232 Product Usage: The System 1 provides
The Issue: Terumo Cardiovascular Systems has received reports of malfunctions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Interface module for CDl System 500 Product Usage: The Interface
The Issue: Terumo Cardiovascular Systems has received reports of malfunctions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.