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 10241–10260 of 38,428 recalls
Recalled Item: Medicina Reusable Oral syringe 2.5ml Code: OTH25
The Issue: Plunger component has been manufactured with an unapproved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medicina Reusable Oral syringe 1ml Code: OTH01
The Issue: Plunger component has been manufactured with an unapproved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Da Vinci S/Si Large Clip Applier
The Issue: Due to the potential for unexpected motion caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Da Vinci X/Xi Large Clip Applier
The Issue: Due to the potential for unexpected motion caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Echelon -14
The Issue: Outer carton packaging of microcatheters were exposed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Echelon -14 Micro Catheter
The Issue: Outer carton packaging of microcatheters were exposed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
The Issue: Manufacturing variance near transition of tip is increasing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
The Issue: Outside packaging for a device indicated for introducing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wolf Pak Premium Dressing Change Kit with Statlock CS/30
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wolf-Pak Premium Dressing Kit with GuardVA Cs/30
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES
The Issue: stability failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE Measured Sizing and Rotation Guide-to size the femur and
The Issue: Manufactured with a Galvanized High Carbon Steel spring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SX-One MicroKnife
The Issue: of dull blade
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOPHEN UFH Control Plasma
The Issue: Incorrect product labeling was included in the package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist Device (HVAD) System Batteries
The Issue: Battery performance issues. Battery electrical faults render it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use
The Issue: Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Description/Item: ChemoLock Bag Spike
The Issue: Ports have a potential for unintended disconnection, inability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Description/Item: ChemoLock Vial Spike
The Issue: Ports have a potential for unintended disconnection, inability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.