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 2501–2520 of 38,428 recalls
Recalled Item: NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0
The Issue: Nerve Monitoring System with certain software versions has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips DXR System
The Issue: for collimator to fall as a result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet VH-3010 Power Supply. Used to deliver power to the
The Issue: Incorrect resistor utilized in the VH-3010 Power Supply,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips DXR System
The Issue: for collimator to fall as a result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TLX/TLC SP Guided Implant Driver
The Issue: The devices are missing the laser marked depth
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
The Issue: Identified curing issues with the silicone during the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
The Issue: Identified curing issues with the silicone during the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
The Issue: Identified curing issues with the silicone during the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
The Issue: Identified curing issues with the silicone during the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Venue Go Models: R2 (Model Number H45181VG)
The Issue: The battery for certain ultrasound systems can potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Venue Fit Models: R3 (Model Number H45303VFSC
The Issue: The battery for certain ultrasound systems can potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pacific Hemostasis Thromboplastin-D
The Issue: The incorrect value of the International Sensitivity Index
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pacific Hemostasis Thromboplastin-D
The Issue: The incorrect value of the International Sensitivity Index
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
The Issue: Due to incorrect the battery charger being packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker Blueprint Mixed Reality Coracoid Clamp
The Issue: Stryker identified an elevated complaint rate related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker Blueprint Mixed Reality Glenoid Digitizer
The Issue: Stryker identified an elevated complaint rate related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker Blueprint Mixed Reality Depth Stop Pin
The Issue: Stryker identified an elevated complaint rate related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker Blueprint Mixed Reality Instrument Kit
The Issue: Stryker identified an elevated complaint rate related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE ReNewal ENT Coblator II PROcise XP Wand
The Issue: Medline ReNewal has identified that the drip chambers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker Blueprint Mixed Reality Box Base
The Issue: Stryker identified an elevated complaint rate related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.