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 31061–31080 of 38,428 recalls
Recalled Item: Medical Device Exchange - GIA Auto Suture Loading Unit w/
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange FEMORAL CANAL TIP
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device Exchange X-SAW BLADE
The Issue: EXP did not register as a medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Milestone Wand STA Handpiece for the delivery of local anesthesia
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry XPT System
The Issue: Siemens Healthcare Diagnostics has confirmed an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Outer cardboard box labeling: Pinnacle Cure Sleeve
The Issue: Cases of Cure Sleeve labeled with part number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMARTSET GHV Gentamicin Bone Cement. A self-curing
The Issue: One lot of SMARTSET GHV Gentamicin Bone Cement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoWrist One Vessel Sealer
The Issue: Intuitive Surgical has identified the potential for a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoWrist One Vessel Sealer
The Issue: Intuitive Surgical has identified the potential for a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G7 Variant Elution Buffer HiS no. 1 (M) component of
The Issue: The G7 Variant Elution Buffer HiS no. 1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T/S2 0.9% Sodium Chloride Injection
The Issue: Incorrect labeling of the expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare DigitalDiagnost System X-Ray
The Issue: The system is designed to emit a beep
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare DuraDiagnost X- Ray
The Issue: The system is designed to emit a beep
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CooperSurgical PESSARY KIT-CUBE#2
The Issue: Incorrect size printed on the Milex Pessary Kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1
The Issue: Possibility of image artifacts during data acquisition when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo HX2 Temperature Management System provides temperature control of two
The Issue: Malfunctioning mixing valve and loss of cooling and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DermaPen Pro Model
The Issue: Derma Pen initiated a field communication for Dermapen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence...
The Issue: 5 issues. Fast Get Ready incorrectly enabled during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-ray systems Brilliance iCT
The Issue: 5 issues. Fast Get Ready incorrectly enabled during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.