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 36621–36640 of 38,428 recalls
Recalled Item: ANSPACH******Custom Medium Attachment
The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH******Nose Cone Cover***Rx Only*** This device is intended to
The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This
The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH******Custom Device Speed Reducer with Bumper***Rx Only*** This device
The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH******Sagittal microSaw Attachment Custom***Rx Only*** This device is...
The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH***Knotless Suture Anchor Deployment Tool
The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH******8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This
The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH******Custom Device eMax2 Plus Hand Control***Rx Only*** This device is
The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH******eMax2 Console with Irrigation***Rx Only*** This device is intended
The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH******7cm Medium Attachment Custom***Rx Only*** This device is intended
The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH******Custom MDA Tube for use with MA-D20 Attachment***Rx Only***
The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH******20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This
The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH******Custom Device eMax 2 Plus Hand Control that will
The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH***Custom XMax Motor
The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BS-200 Chemistry Analyzer Designed for clinical laboratory use.
The Issue: An issue has been identified with the BS-200
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry...
The Issue: Due to a software data storage limitation which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mindray DS USA
The Issue: Mindray has identified a software anomaly that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
The Issue: The COBAS TaqMan MTB Test Definition Files (TDF)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Immunoradiometric assay. Device is an immunoradiometric assay designed for the
The Issue: The recall was initiated because Siemens Healthcare Diagnostics
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Immunoradiometric assay.
The Issue: The recall was initiated because Siemens Healthcare Diagnostics
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.