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 16341–16360 of 38,428 recalls
Recalled Item: MICRO-PSD HDR
The Issue: May result in readings outside of the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICRO-PSD Electron
The Issue: May result in readings outside of the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICRO-PSD EXTERNAL BEAM PHOTON
The Issue: May result in readings outside of the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LivaNova USA Sterile Disposable Connector
The Issue: Some packages of sterile disposable connectors contained a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gore DrySeal Flex Introducer Sheath
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ViewRay System: Model No. 10000 and 20000 for radiation treatment.
The Issue: Registering dose and structures in the treatment delivery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm
The Issue: Some of the implants were packaged with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: There is a complaint regarding internal check cable guide mechanism
The Issue: A component failure may lead to treatment interruption
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation stand-alone software treatment planning system
The Issue: Editing a static arc beam may unexpectedly set
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STA SYSTEM CONROL N + P (ref. 00678)
The Issue: A positive bias was confirmed to exists on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STA UNICALIBRATOR (ref. 00675)
The Issue: A positive bias was confirmed to exists on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elasto-Gel Absorbent Wound Dressing
The Issue: Elasto-Gel Wound Dressing may be contaminated with mold
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BOND Polymer Detection Kit
The Issue: BOND Polymer Refine Detection kits (DS9800) were held
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Habib EUS RFA
The Issue: During testing on the Habib EUS RFA device,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Habib EUS RFA
The Issue: During testing on the Habib EUS RFA device,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revaclear Capillary Dialyzer 300
The Issue: There is the potential presence of particular matter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PneumoDart
The Issue: A defect involving an occluded needle was discovered
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-arm" O2 Imaging System
The Issue: Due to a manufacturing issue affecting particular O-arm"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment
The Issue: The AIA-2000 bar code scanners depend on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
The Issue: leak in the balloon extension line. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.