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 8621–8640 of 38,428 recalls
Recalled Item: MectaLIF ANTERIOR - Antibackout Lag Cover
The Issue: There is a potential for breakage of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MectaLIF ANTERIOR - Lag Plate Flush H18
The Issue: There is a potential for breakage of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MectaLIF ANTERIOR - Lag Plate Flush H12
The Issue: There is a potential for breakage of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MectaLIF ANTERIOR - Lag Plate Flush H16
The Issue: There is a potential for breakage of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray
The Issue: Issue related to the operation of the arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended
The Issue: Error in the Introduction section of the user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01
The Issue: EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01
The Issue: EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System
The Issue: Some batches of product were not sterilized to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VASOVIEW HEMOPRO
The Issue: Some batches of product were not sterilized to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System
The Issue: Some batches of product were not sterilized to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProxiDiagnost N90 R.1.0
The Issue: Philips has identified a compliance issue where ProxiDiagnost
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CombiDiagnost R90 R.1.0
The Issue: Philips has identified a compliance issue where ProxiDiagnost
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroPICC 4Fr Single Lumen Catheter
The Issue: The catheter packaged with specific lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CombiDiagnost R90 R1.1
The Issue: Philips has identified a compliance issue where ProxiDiagnost
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SafeLight Fiber Optic Cable: Clear
The Issue: Fiber optic cables assembled with not enough epoxy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion CirClamp with 1.3cm Bell & Insert Reprocessed
The Issue: The CirClamp subassembly found in the kit was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for
The Issue: Not programmed in accordance with specification. The programming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cirq Arm System 2.0
The Issue: Risk of mechanical instability due to potential manufacturing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titan Pump Assembly
The Issue: A decrease in wall thickness has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.