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 32601–32620 of 38,428 recalls
Recalled Item: Prismaflex M60 set. Product number 106696. 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 M100 set. Product number 104182. 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: BD Multi Check CD4 Low Control Catalog No. 340916 is
The Issue: The outer box label contains the incorrect distribution
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir
The Issue: ICU has become aware of an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices
The Issue: ICU has become aware of an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Line Transpac IV Monitoring Kit w/03 ml Squeeze 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: Arterial Transpac IT Monitoring Kit w/Safeset Reservoir
The Issue: ICU has become aware of an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transpac IT w/3 ML/HR Macrodrip
The Issue: ICU has become aware of an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transpac IT w/10 cc Safeset Reservoir
The Issue: ICU has become aware of an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir
The Issue: ICU has become aware of an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only
The Issue: Genesis BPS is recalling numerous devices since they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS
The Issue: Genesis BPS is recalling numerous devices since they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS
The Issue: Genesis BPS is recalling numerous devices since they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a
The Issue: This remedial action is the result of six
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TomoTherapy Treatment System
The Issue: Accuray is voluntarily recalling TomoTherapy H Series software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
The Issue: The Instructions for Use for the Pentax OF-B130
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vital Sync" VPMP & IM
The Issue: Covidien is conducting a field correction of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vital Sync RMS 1.0 when loaded with v2.4 software
The Issue: Covidien is conducting a field correction of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tapered-Screw Vent Implant
The Issue: Zimmer Dental is recalling the Tapered Screw-Vent Implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instructions for Use for the blue endo MOREsolution Electromechanical...
The Issue: Some pages of the Instructions for Use were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.