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 28401–28420 of 38,428 recalls
Recalled Item: BacT/ALERT¿ FA
The Issue: Bottles may have been exposed to non-normal shipping
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal
The Issue: One complaint of a seat on a scale
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoscope ED-250XL5 Operations Manual: Cleaning
The Issue: This correction is in response to publicized reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoscope ED-450XL5 Operation Manual: Cleaning
The Issue: This correction is in response to publicized reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
The Issue: This correction is in response to publicized reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoscope
The Issue: This correction is in response to publicized reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoscope ED-450XT5 Operation Manual: Cleaning
The Issue: This correction is in response to publicized reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the
The Issue: The sterile battery may contain particulates within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to
The Issue: The sterile battery may contain particulates within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00549470 (XMD
The Issue: A feeding (reflux) valve leakage issue. The feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00549530 (XMD
The Issue: A feeding (reflux) valve leakage issue. The feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD
The Issue: A feeding (reflux) valve leakage issue. The feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD
The Issue: A feeding (reflux) valve leakage issue. The feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00549450 (XMD
The Issue: A feeding (reflux) valve leakage issue. The feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00549400 (XMD
The Issue: A feeding (reflux) valve leakage issue. The feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548270 (XMD
The Issue: A feeding (reflux) valve leakage issue. The feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548240 (XMD
The Issue: A feeding (reflux) valve leakage issue. The feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548890 (XMD
The Issue: A feeding (reflux) valve leakage issue. The feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00549370 (XMD
The Issue: A feeding (reflux) valve leakage issue. The feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00549540 (XMD
The Issue: A feeding (reflux) valve leakage issue. The feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.