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 36401–36420 of 38,428 recalls
Recalled Item: BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M
The Issue: The recall was initiated because Breg has determined
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC)
The Issue: Due to past battery inventory storage conditions and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: P10 Tobii battery box (product number 510410) Product Usage -
The Issue: Tobii ATI customers P10 external battery pack, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Oracle Spacer System Slap Hammer
The Issue: This recall is being initiated in response to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inspira AIR Balloon Dilation system. Size 14 x 40 mm
The Issue: Labeling correction for all sizes of the Inspira
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inspira AIR Balloon Dilation system. Size 5 x 24 mm
The Issue: Labeling correction for all sizes of the Inspira
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inspira AIR Balloon Dilation system. Size 10 x 40 mm
The Issue: Labeling correction for all sizes of the Inspira
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm
The Issue: Labeling correction for all sizes of the Inspira
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inspira AIR Balloon Dilation system. Size 12 x 40 mm
The Issue: Labeling correction for all sizes of the Inspira
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inspira AIR Balloon Dilation system. Size 16 x 40 mm
The Issue: Labeling correction for all sizes of the Inspira
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inspira AIR Balloon Dilation system. Size 7 x 24 mm
The Issue: Labeling correction for all sizes of the Inspira
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexible Grip which is part of the Synthes Universal Nail
The Issue: Synthes is initiating a voluntary recall of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Dens Instrument Set (Dens Graphic Case)
The Issue: The Dens Instrument Set has been designed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate
The Issue: It was discovered that one of the VA-LCP
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual
The Issue: Lot number 7542279, of the 45 mm Click
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Multi-Vector Distractor Body
The Issue: It was discovered that the sheer pin on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Titanium Midface Distractor
The Issue: There is the potential for the anterior footplates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Large Combination Clamp/Large External Fixation System
The Issue: The L1 hex nuts, used to tighten the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left)
The Issue: It was discovered that the sheer pin on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Multi-Vector Distractor
The Issue: It was discovered that the sheer pin on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.