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 32581–32600 of 38,428 recalls
Recalled Item: Medtronic MiniMed Guardian Monitor
The Issue: Medtronic MiniMed is recalling the Guardian REAL-Time monitors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex HF 1400. Product number 107142. Each set is packaged
The Issue: Gambro initiated a field action on the Prisma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier
The Issue: RENASYS EZ Canisters exhibiting visible evidence of deformation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier
The Issue: RENASYS EZ Canisters exhibiting visible evidence of deformation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP)
The Issue: RENASYS EZ Canisters exhibiting visible evidence of deformation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Transpac IT Monitoring Kit w/03 ml Flush Device
The Issue: ICU has become aware of an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stago IVD
The Issue: Diagnostica Stago Inc. received some customer complaints regarding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP
The Issue: ICU has become aware of an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prisma M 100 PRE set. Product number 103657. Each set
The Issue: Gambro initiated a field action on the Prisma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prisma M 60 PRE set (new design). Product number 103658.
The Issue: Gambro initiated a field action on the Prisma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prisma TPE 2000 set. Product number 109672. Each set is
The Issue: Gambro initiated a field action on the Prisma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch
The Issue: Gambro initiated a field action on the Prisma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US)
The Issue: Gambro initiated a field action on the Prisma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex HF 1000. Product number 107140. Each set is packaged
The Issue: Gambro initiated a field action on the Prisma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prisma HF1000 preset (new design). Product number 107639. Each set
The Issue: Gambro initiated a field action on the Prisma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch
The Issue: Gambro initiated a field action on the Prisma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US)
The Issue: Gambro initiated a field action on the Prisma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex TPE 2000 set
The Issue: Gambro initiated a field action on the Prisma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prisma M100 PRE pump infusion set. Product number 107791. Each
The Issue: Gambro initiated a field action on the Prisma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prisma M60 POSTDILUTION set. Product number 104183. Each set is
The Issue: Gambro initiated a field action on the Prisma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.