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 36041–36060 of 38,428 recalls
Recalled Item: Brilliance CT 64
The Issue: If the operator selects a patient name from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The GemStar Pump is a small and lightweight
The Issue: During infusions of 2.0 mL/hr the motor assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The GemStar Pump is a small and lightweight
The Issue: During infusions of 2.0 mL/hr the motor assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry
The Issue: Beckman Coulter, Inc. initiated this recall because there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxford Uni Knee System
The Issue: Investigation of complaints found excessive use of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HORIBA ABX PENTRA 400 I.S.E. Module
The Issue: HORIBA Medical is informing all ABX PENTRA 400
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GemStar infusion pump
The Issue: Some patients are obtaining access to the dosage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GemStar infusion pump
The Issue: Some patients are obtaining access to the dosage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accuray CyberKnife System Medical Physicist
The Issue: A defect on the master-side connector block of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PSS Select medical products***Biopsy Punches*** Disposable manual instrument...
The Issue: Due to lack of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
The Issue: Due to lack of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for...
The Issue: Due to lack of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRUE Dilatation Balloon Valvuloplasty Catheter
The Issue: Slow deflation time: Slower than normal balloon deflation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shimadzu Corporation - Mobile DaRt Evolution This device is a
The Issue: The recall was initiated because Shimadzu Corporation has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HD Still Capture System ConMed Linvatec . Captures
The Issue: The VP1600 HD Still Capture Image System is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Stent Guide: 1102-00 (100 strips)
The Issue: Devices were not sealed correctly during the manufacturing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GemStar Pump - Battery Product Usage: The GemStar Pump is
The Issue: Battery level lower then 2.4 volts results in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The GemStar Pump is a small and lightweight
The Issue: Pump shutting off during use without warning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage PureFlow-B Solution
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The GemStar Pump is a small and lightweight
The Issue: Pump shutting off during use without warning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.