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 18441–18460 of 38,428 recalls
Recalled Item: Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON
The Issue: Advisory issued not to disable or bypass the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg
The Issue: Edi Catheter labeled with wrong expiry date on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIR Technology Anterior Array
The Issue: The outer seam of the coil, closest to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neomem Resorbable Collagen Membrane
The Issue: Product was packaged in the wrong box; may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OnSight 3D Extremity System- X-Ray
The Issue: When the user performs the re-assignment of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Performance Series Sagittal Blade
The Issue: During manufacture, packaging materials for a small portion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOPHEN UFH Control C1
The Issue: The manufacturer packaged incorrect versions of the Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOPHEN LMWH Control C4
The Issue: The manufacturer packaged incorrect versions of the Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOPHEN UFH Control C2
The Issue: The manufacturer packaged incorrect versions of the Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS
The Issue: Three materials used in the makeup of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IDEAL IMPLANT Structured Breast Implant
The Issue: The implants were deflating due to a piece
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS011 GNR PNA FISH Control Slide
The Issue: May show diminished performance prior to its established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cios Alpha
The Issue: Continuous operation at very high tube output may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRIdian Linac Radiation Therapy System
The Issue: A discrepancy between optimization and planning forward dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Albumin BCP Product Usage: ALBP is an in vitro test
The Issue: The reagent lot is exhibiting calibration failures, QC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Laboratories Ltd. Catalogue Number CQ5052
The Issue: The form received three complaints related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SHERPA NX ACTIVE GUIDING CATHETER
The Issue: There is a potential for extensive loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SHERPA NX ACTIVE GUIDING CATHETER
The Issue: There is a potential for extensive loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SHERPA NX ACTIVE GUIDING CATHETER
The Issue: There is a potential for extensive loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SHERPA NX ACTIVE GUIDING CATHETER
The Issue: There is a potential for extensive loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.