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 37281–37300 of 38,428 recalls
Recalled Item: 16 Fr HemoStar XK Long-Term Hemodialysis Catheter
The Issue: Bard Access Systems is recalling one lot of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nidek Excimer Laser Corneal Surgery System
The Issue: Contact failure in F1 and F4 fuse holders
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic...
The Issue: There is a possibility that the ISKD limb
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes(R) Spine Vectra
The Issue: Although the reported incidence is low, there is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes(R) Spine Vectra
The Issue: Although the reported incidence is low, there is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Howmedica Osteonics
The Issue: During the manufacturing of the affected lot a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically...
The Issue: The seat could break as a result of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix
The Issue: Diamedix Corporation recalled their Is-anti-Sm Test Kit due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare¿ I-Fit" Shower Chair (Models 9780
The Issue: On August 6, 2012, Invacare voluntarily recalled the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Precise Digital Accelerator Delivery of radiation to defined target volumes
The Issue: There have been a small number of instances
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
The Issue: GE Healthcare has become aware of a software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an
The Issue: Cartridges are leaking. The leaking is observed when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet
The Issue: Biomet 3i recalled their Osseotite Tapered Certain Implant,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE
The Issue: Ethicon Endo-Surgery initiated this voluntary global recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top
The Issue: Low Abnormal Fibrinogen Sample Reports as Normal and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is
The Issue: Low Abnormal Fibrinogen Sample Reports as Normal and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 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: Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top
The Issue: Low Abnormal Fibrinogen Sample Reports as Normal and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 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: HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien)
The Issue: failure of HALO Energy Generator to enter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.