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 37301–37320 of 38,428 recalls
Recalled Item: Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP
The Issue: Low Abnormal Fibrinogen Sample Reports as Normal and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Newport HT70 and HT70 Plus Ventilators
The Issue: May emit a continuous high priority alarm and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Brilliance 6
The Issue: The patient support may move in an unintended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration
The Issue: Devices leaking at the Y-site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: E-Z WIDER BARIATRIC CHAIR BED
The Issue: An EZ Wider bed (capacity of 1000 lb
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Empty Vial and Injector (30mL PCA vial)
The Issue: Reports of leaking during filling and administration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 100 ft roll of tubing inside a cardboard box. Medical
The Issue: On 7/20/2012 the firm became aware that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test...
The Issue: Customers were not following the labeled assay procedure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The
The Issue: GE Healthcare has become aware of a software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Optima XR 200 amx with Digital Upgrade. The
The Issue: GE Healthcare has become aware of a software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The
The Issue: GE Healthcare has become aware of a software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E
The Issue: The firm initiated a recall after complaint investigations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA
The Issue: Covidien is conducting a recall of various production
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic
The Issue: It was identified that BRAF controls dispositioned as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: V60 Ventilator
The Issue: Respironics is recalling the V60 ventilator because certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Custom Implant Devices Packaging: Packaging was not standardized on
The Issue: In connection with a Warning Letter received from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R)...
The Issue: Firm has confirmed highter imprecision with the recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DEXIS Imaging Suite - catalog number 1.008.7932
The Issue: A condition can occur during renumbering of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS
The Issue: Offset Bushings associated with the lots identified were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS
The Issue: Offset Bushings associated with the lots identified were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.