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 24981–25000 of 38,428 recalls
Recalled Item: AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN)
The Issue: Boston Scientific has received field reports regarding the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRODISC Orthopedic Manual Surgical Instrument
The Issue: These items are incorrectly etched and labeled. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jackson-Pratt Channel Drain Silicone Round
The Issue: Product sterility compromised due to breach of sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A-series lift - A625 Manual Part No. 324117. Prism Medical.
The Issue: During internal cycle test at max load (625
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LipiFlow Thermal Pulsation System/LipiFlow
The Issue: Labeling: The labeled storage temperature is not consistent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A-series lift - A625 Manual w/Load Cell & Wi-Fi
The Issue: During internal cycle test at max load (625
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iChemVELOCITY Urine Chemistry System
The Issue: The probe misalignment or bending has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EliA Sample Diluent
The Issue: Erroneous EliA test results related to problems with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Daavlin Aquex (DAAV1000)
The Issue: The device was reclassified from a class III
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hidrex USA DVP1000
The Issue: The device was reclassified from a class III
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hidrex USA DP450
The Issue: The device was reclassified from a class III
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg
The Issue: After a receiving a customer complaint for incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hand Foot II
The Issue: The wiring may allow the lamps to turn
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The
The Issue: Maquet has received several complaints involving the VASOVIEW
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Valleylab Laparoscopic Handset
The Issue: Customer reports of the device handset continuing to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
The Issue: SIGMA Spectrum Infusion Pumps with Master Drug Library,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABL90 Flex Model #: 393-090 Portable
The Issue: Reports that the sample type "cord blood" has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ABL800 Model#:All
The Issue: Reports that the sample type "cord blood" has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONCOR Impression
The Issue: Siemens became aware of Incorrect values for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRIMUS HI and Mevatron M2/Primus Mid-Energy
The Issue: Siemens became aware of a defective weld seam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.