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 25841–25860 of 38,428 recalls
Recalled Item: DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW
The Issue: SKYLINE Variable Ti screws may have contained SKYLINE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW
The Issue: SKYLINE Variable Ti screws may have contained SKYLINE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW
The Issue: SKYLINE Variable Ti screws may have contained SKYLINE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW
The Issue: SKYLINE Variable Ti screws may have contained SKYLINE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-Max" Cutting Loop Electrodes
The Issue: Defect; The contact part could possibly separate from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere Triage Total 5 Control Level 1
The Issue: Encoded with incorrect ranges that are not consistent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GAMBRO Capillary Dialyzer
The Issue: presence of particulate matter on the blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device
The Issue: Contract manufacturer packaged an incorrect sheath with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA Brain
The Issue: Complaint of the head holder connector locking up
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Algovita Spinal Cord Stimulation System
The Issue: Nuvectra is conducting a recall due to two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiation Therapy Treatment Planning System Product Usage: RayStation is a
The Issue: An error may occur with the display of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay
The Issue: Abbott has identified negative interference from the drug
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RF MultiGen¿
The Issue: Stryker Instruments is voluntarily recalling the Care Instructions/Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers:
The Issue: The firm is voluntarily recalling lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unify
The Issue: St Jude Medical is recalling implantable cardiac defibrillator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quadra Assura
The Issue: St Jude Medical is recalling implantable cardiac defibrillator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fortify VR
The Issue: St Jude Medical is recalling implantable cardiac defibrillator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advia Chemistry Calibrator For in vitro diagnostic use in the
The Issue: Siemens has confirmed that the DBIL_2 Assigned Calibrator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rotating Adult Craniotome Product Usage: Pneumatic system
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Foot Control without Switches
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.