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 38121–38140 of 38,428 recalls
Recalled Item: OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6...
The Issue: Exactech, Inc. of Gainesville, FL is recalling their
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806)
The Issue: CODAN US Corporation is recalling the ColorSafe IV
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage:
The Issue: In GUI inquiry, searching by ID (CID) may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CrossFT Punch
The Issue: ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens syngo.plaza image processing system image processing radiological system
The Issue: The firm became aware of an unintended behavior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel Dxl 800 Access Immunoassay System
The Issue: The recall was initiated because Beckman Coulter has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel Dxl 600 Access Immunoassay System
The Issue: The recall was initiated because Beckman Coulter has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxC 880i
The Issue: The recall was initiated because Beckman Coulter has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Immunoassay Systems Total T4 Calibrators
The Issue: A recall communication was initiated because Beckman has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE
The Issue: Fastener bolts on the heat exchanger were not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SL3 SOFT-TISSUE Laser (Model LR2002)
The Issue: The firm is initiating this recall of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medpro Elastomeric Infusion Pump. AccuFlux
The Issue: Please be aware that this is not a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model...
The Issue: Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ILLICO Straight CP TI Rod
The Issue: The rods were incorrectly laser etched as ILLICO¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sigma Spectrum VOLUMETRIC INFUSION PUMP
The Issue: Recall expansion; the infusion pumps have the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number:
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction...
The Issue: ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc Blood Analysis BGEM Test Cards for use with the
The Issue: Customer reported problem while performing incoming QC of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.