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 21941–21960 of 38,428 recalls
Recalled Item: Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with...
The Issue: that one or more image series may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMI (Collagen Meniscus Implant) device
The Issue: The recalled products were shipped without the required
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-arm 1000 mobile image-intensified fluoroscopic x-ray system
The Issue: Software update ("SW Update 3.2.1") is being implemented
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VNS Therapy Programming System
The Issue: Unintended warning message displayed on generators programmed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stage-1 Tissue Punch
The Issue: The cutting edge of tissue punches may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer
The Issue: Certain lots of M-30D diluent used with BC-3200
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hematology Diluent M-53D used with BC-5390 Hematology Analyzer
The Issue: Certain lots of M-30D diluent used with BC-3200
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liberty Select Cycler (SW v.2.8.7)
The Issue: The recalling firm identified a software issue related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DynaCad software consist of an MR Analysis Server software and
The Issue: Following update from 3.3 to 3.5 of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML
The Issue: One lot of humeral stem implants do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is
The Issue: Missing desiccant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Bair Hugger(M) Normothermia System
The Issue: Adesign change to 3M(TM) Bair Hugger(TM) Full Access
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Bair Hugger(M) Normothermia System
The Issue: Adesign change to 3M(TM) Bair Hugger(TM) Full Access
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Implant Direct
The Issue: InterActive Healing Collar, Lot Number 104203, labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apollo XT Suture Anchor
The Issue: The label on Apollo XT 5.5mm Suture Anchor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DS Titanium Ligation Clip
The Issue: Added a contraindication to IFU: Do not use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DS Titanium Ligation Clip Appliers
The Issue: Added a contraindication to IFU: Do not use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B
The Issue: DeRoyal manufactured custom sterile surgical kits containing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond
The Issue: This Correction is being initiated based on a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hologic Panther(R) Fusion(TM)
The Issue: The Panther or the Panther Fusion glass panel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.