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 31101–31120 of 38,428 recalls
Recalled Item: Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper
The Issue: Monitor Ceiling Suspension system may fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage:
The Issue: Monitor Ceiling Suspension system may fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Xper vascular system Model : 722124 Product Usage:
The Issue: Monitor Ceiling Suspension system may fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product
The Issue: Monitor Ceiling Suspension system may fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Xper cardio systems Model : 722123 Product Usage:
The Issue: Monitor Ceiling Suspension system may fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20
The Issue: Monitor Ceiling Suspension system may fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aspire HD
The Issue: User Manual lacks a description for handling some
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Inserter for Titanium Elastic Nails
The Issue: The Inserter has the potential for mechanical failures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material...
The Issue: Reports of formation of char adherent to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LFT v40 Femoral Head
The Issue: Three customer complaints were received for the same
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Manual Toothbrush
The Issue: The toothbrush head can potentially disengage from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw
The Issue: A component failure could cause a situation where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair)
The Issue: The batteries used in the Invacare¿ Pronto¿ Air
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD" Medication Cassette Reservoir
The Issue: Smiths Medical has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVOLUTION MP TIBIAL BASE
The Issue: Some units of the EVOLUTION Tibial Base was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COMPASS SW Version 3.1
The Issue: Error in the software. During internal tests of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various OxyTOTE Portable Oxygen System regulators
The Issue: The firm has become aware of the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard 100% Latex-Free Urinary Drainage Bag with Anti- Chamber and
The Issue: breach of the sterile barrier packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The
The Issue: If the patient sits on either wing, not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Proteus XR/a with wall stand model number 2260354.
The Issue: breakage of the steel cable which supports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.