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 33481–33500 of 38,428 recalls
Recalled Item: Synthes XRL Medium Trial - Central Body
The Issue: Two lots of the Synthes XRL Medium Trial-Central
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests)
The Issue: There is an issue with the buffers which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lipase Reagent
The Issue: Package inserts have incorrect SmartWash parameters for Triglyceride
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
The Issue: Separation events have occurred, including the VIPR separating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination
The Issue: JAS Diagnostics, Inc. of Miami Lakes, FL is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SBi RingFix Olive Wires Product Usage: These are temporary devices
The Issue: Small Bone Innovations (SBI) is recalling non-sterile RingFIX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PolypVac 3.5mm Microdebrider
The Issue: The reciprocation mechanism in the PolypVac Microdebrider may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vertical Spring Arm for Single or Dual Monitor Mount (Harmony
The Issue: for the welded seam in affected monitor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIGEN INTERTAN NAIL: (1)
The Issue: A manufacturing error resulted in the set screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIGEN INTERTAN 1.5 NAIL: (1)
The Issue: A manufacturing error resulted in the set screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lithium Ion Battery M4605A and M4607A for use with IntelliVue
The Issue: The risk of battery failure increases with age,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit 8551/856X (includes Models 8561
The Issue: Some refill kits in the affected lots may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy
The Issue: Additional warning in the AMIA APD System labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum
The Issue: There is a potential safety risk associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with
The Issue: B.Braun Medical, Inc. (BBMI) has received reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Centricity PACS Workstation is intended for use as a
The Issue: It has been identified that in a reject
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo Imaging XS Syngo Imaging XS is a Picture Archiving
The Issue: A complaint reported that the archiving method at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo Dynamics v9.5 system. A Picture Archiving and Communication System
The Issue: Systems with the affected serial number are experiencing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.