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 16101–16120 of 38,428 recalls
Recalled Item: Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Enzymatic Creatinine (ECREA) reagent
The Issue: There is a potential for falsely depressed creatinine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Enzymatic Creatinine (ECRE_2) reagent
The Issue: There is a potential for falsely depressed creatinine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM)
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23
The Issue: There is a potential for packaging integrity issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.