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 17941–17960 of 38,428 recalls
Recalled Item: Arrowg+ard Blue Advance JACC Product Code: JRT 43541 HPHNM
The Issue: Lidstock states the incorrect expiration date for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrowg+ard Blue Advance JACC Product Code:CDC 42052 JX1A
The Issue: Lidstock states the incorrect expiration date for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42063 HPHNM
The Issue: Lidstock states the incorrect expiration date for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM
The Issue: Lidstock states the incorrect expiration date for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM
The Issue: Lidstock states the incorrect expiration date for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrowg+ard Blue Advance JACC Product Code: CDC 41541 JX1A
The Issue: Lidstock states the incorrect expiration date for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Processor SP
The Issue: Two of three complaints were initiated due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr
The Issue: Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN:...
The Issue: Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliSpace PACS 4.4
The Issue: Images may potentially become corrupt while using the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acidified Concentrate Distribution and Storage System (ACDS System) with a
The Issue: There is a potential for an uneven plastic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with
The Issue: There is a potential for an uneven plastic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
The Issue: There is a potential for an uneven plastic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monarch
The Issue: Reports of aspirating biopsy needle breakage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1
The Issue: Possibility that a suture raw material containing high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX
The Issue: Possibility that a suture raw material containing high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SureSigns VS3 NBP Temp
The Issue: System software inhibits the monitor and as a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SureSigns VS3 NBP
The Issue: System software inhibits the monitor and as a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SureSigns VS3 NBP
The Issue: System software inhibits the monitor and as a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SureSigns VS3 NBP
The Issue: System software inhibits the monitor and as a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.