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 19681–19700 of 38,428 recalls
Recalled Item: RayStation 4.5
The Issue: Robust optimization for plans using beam set +
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station
The Issue: The device may not function at the lower
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid IABP
The Issue: There is a potential for interruption and/or inability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue IABP
The Issue: There is a potential for interruption and/or inability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single-Use Biopsy Forceps
The Issue: Single-Use Biopsy Forceps box contains incorrect product, instead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AS-OBGYN Information System version 7.824.x
The Issue: Any change made to current ultrasound machine software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexible Drill Shaft
The Issue: Manufacturing error, the drill bit shaft is unable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips DigitalDiagnost software 4.1.x and 4.2.x
The Issue: Stitching run on SkyPlate detector interrupted intermittently; Stitching
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Access Cortisol Reagent. REF (Catalog Number) 33600
The Issue: Cross contamination may have occurred between wells for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric
The Issue: Software Update: External USB Drive performance and its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK
The Issue: One lot of the Legion AP femoral cutting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE
The Issue: If an operator attempts to manually program a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kaluza C Flow Cytometry Software
The Issue: Compatibility issue between the software and Microsoft updates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic...
The Issue: O-arm 02 Imaging Systems correction to software version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301
The Issue: The power supply unit for the printer used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NucliSENS¿ Magnetic Extraction Reagents
The Issue: Data loggers showed that one shipment to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed Agilis Steerable Introducer: indicated for introducing various...
The Issue: Reprocessed Agilis Steerable Introducers may not meet endotoxin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SORIN Heater-Cooler System 3T
The Issue: For six units, the post-deep cleaning (DC) water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE LOGIQ E10 Ultrasound System
The Issue: There is a potential for an undetected over
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Millennium MC
The Issue: A detector can detach and fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.