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 33841–33860 of 38,428 recalls
Recalled Item: Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator
The Issue: Customer reported that the Synchron NBUP cutoff calibrator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxoid Vancomycin 30 mcg
The Issue: Some of the discs may not be impregnated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with...
The Issue: When the HeartStart MRx.is used with the Q-CPR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A
The Issue: MRx may display a Red X in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart
The Issue: Wireless Link may be unable to transmit data
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartStart MRx Monitor/Defibrillator
The Issue: A component of the MRx Processor Board may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The
The Issue: Philips HeartStart MRx Monitor/Defibrillator, when operating on battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart MRx Monitor/Defibrillator
The Issue: ECG trunk cable and connector block of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TDWorkstation version 11.01.A or higher. TDWorkstation Evolution....
The Issue: If a conflict occurs between a Demography Query
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XiO RPT System The XiO RTP System is used to
The Issue: Dose and Monitor Unit values are not computed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triton FP Infusion Pump
The Issue: WalkMed Infusion is initiaing a recall on their
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA Surgical Device 2.5.8. It is intended to be used
The Issue: An undetected shift between the information displayed in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RaySearch Ray Station Radiation Therapy Treatment Planning System
The Issue: RaySearch Laboratories has recalled "RaySearch Ray Station 2.0,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11
The Issue: Spacelabs has voluntarily recalled G2 Clinical Access Software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Optima CT580/Discovery CT590RT scanners running software...
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s):
The Issue: HORIBA Medical initiated this recall of all software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart XL
The Issue: Philips HeartStart XL may experience a power board
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MULTIX FUSION. The Multix Fusion system is a radiographic system
The Issue: It was observed that the corrugated hose holder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VerifyNow IIb/IIIa Test
The Issue: Accumetrics is recalling the VerifyNow IIb/IIIa test because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.