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 4441–4460 of 38,428 recalls
Recalled Item: smiths medical portex
The Issue: Uncertainty in the seal integrity of the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical portex
The Issue: Uncertainty in the seal integrity of the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical portex
The Issue: Uncertainty in the seal integrity of the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: prodisc C SK
The Issue: During the assembly of Prodisc C, a blue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: prodisc C SK
The Issue: During the assembly of Prodisc C, a blue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VTC Regular Kit Nephrostomy Catheter System Kit
The Issue: There is the potential for holes in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit
The Issue: There is the potential for holes in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexima Regular Kit Biliary Catheter System Kit
The Issue: There is the potential for holes in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexima APDL Drainage Catheter System and Kit
The Issue: There is the potential for holes in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for
The Issue: May intermittently produce falsely resistant results for pyrazinamide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mazor X. Model Number
The Issue: Software anomalies which can result in two separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PE Centrifuge Temperature Controlled
The Issue: The adhesive joint between the plastic socket and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Power Express
The Issue: The adhesive joint between the plastic socket and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PE Centrifuge
The Issue: The adhesive joint between the plastic socket and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectrum Wireless Battery Modules A/B/G/N
The Issue: The Spectrum WBM may fail to auto-document infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Spectrum Wireless Battery Modules A/B/G/N
The Issue: The Spectrum WBM may fail to auto-document infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WAVEWRITER ALPHA: Model: SC-1216
The Issue: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD-Solis Li-ion Rechargeable Battery Packs
The Issue: Damage to the battery pack may have caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls
The Issue: Beckman Coulter has become aware of an increase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo
The Issue: Firm has released a mandatory software update Version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.