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 11841–11860 of 38,428 recalls
Recalled Item: Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments
The Issue: Software: A coding error associated with the Fast3D
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments
The Issue: Software: A coding error associated with the Fast3D
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific
The Issue: Software: A coding error associated with the Fast3D
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments
The Issue: Software: A coding error associated with the Fast3D
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments
The Issue: Software: A coding error associated with the Fast3D
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments
The Issue: Software: A coding error associated with the Fast3D
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments
The Issue: Software: A coding error associated with the Fast3D
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bivona Aire-Cuf Endotracheal Tube
The Issue: Inadequate pouch seal leading to a compromised sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bivona Uncuffed Wire Endotracheal Tubes
The Issue: Inadequate pouch seal leading to a compromised sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access hsTnI High Sensitivity Troponin I
The Issue: Through customer feedback, testing a sample with cardiac
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for
The Issue: Incorrect version of labels were used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin
The Issue: There is a potential for open seals which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the
The Issue: Incorrect version of labels were used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose
The Issue: Incorrect version of labels were used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zoll
The Issue: Labeling update concerning potential leaks from the catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ion Flexison Biopsy Needle
The Issue: for the sheath tip on the biopsy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL
The Issue: Labeling update concerning potential leaks from the catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL
The Issue: Labeling update concerning potential leaks from the catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zoll
The Issue: Labeling update concerning potential leaks from the catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.