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 16221–16240 of 38,428 recalls
Recalled Item: ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring
The Issue: Inability to dose the test strips, may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion-Drive Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT
The Issue: Incomplete seals on the sterile package may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe Blue Spot PT LiteTM Phototherapy System
The Issue: There is a potential for some systems built
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion- I86625 DEBRIDEMENT TRAY
The Issue: Incomplete seals on the sterile package may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSY
The Issue: Incomplete seals on the sterile package may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT...
The Issue: Incomplete seals on the sterile package may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178
The Issue: Incomplete seals on the sterile package may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER
The Issue: Incomplete seals on the sterile package may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion-Irrigation Kit IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD Y
The Issue: Incomplete seals on the sterile package may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C...
The Issue: Incomplete seals on the sterile package may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY
The Issue: Incomplete seals on the sterile package may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT
The Issue: Incomplete seals on the sterile package may compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth
The Issue: 103 packaged and labeled tubes (103 product tubes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model 250D Ambulatory Blood Pressure Monitor labeled under the following
The Issue: The Bravo Mini (Model 250D), Agilis Mini (Model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS Varicella Zoster IgG (VZG) antibody IVD
The Issue: Two batches of VIDAS Varicella-Zoster IgG (VZG ref
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABS800 Chemistry Analyzer Part Number BA81F-PA00001
The Issue: The gas spring on the front and rear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003
The Issue: The gas spring on the front and rear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fast-Cath Trio HEMOSTASIS INTRODUCER
The Issue: Fast-Cath Trio Hemostasis Introducer devices contained 12F sized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fast-Cath Hemostasis Introducer
The Issue: Three lots of Fast-Cath Hemostasis Introducer devices contained
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Karl Storz SE & Co. KG
The Issue: The firm has become aware that there is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.