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 6381–6400 of 38,428 recalls
Recalled Item: Bard¿ Nasogastric Sump Tube with ENFit
The Issue: BD (C.R. Bard) has received user complaints reporting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical Medfusion Model 4000 Syringe pump
The Issue: Medfusion Model 4000, 3500, and 3010 pumps manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical Medfusion Guide Barrel Clamp
The Issue: Medfusion Model 4000, 3500, and 3010 pumps manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical Medfusion Model 3500 Syringe pumps
The Issue: Medfusion Model 4000, 3500, and 3010 pumps manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010
The Issue: Medfusion Model 4000, 3500, and 3010 pumps manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acu-Loc and Acu-Loc 2 bone plates
The Issue: Distribution without Pre-Market Clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM
The Issue: Affected batches of the kit contain Stoma Measuring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accessory Sets Syringes: 6ml syringe with a female luer with
The Issue: Accessory sets contain a syringes not yet qualified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical Medfusion Model 3500 Syringe pump
The Issue: Medfusion syringe pumps, with software versions before v6.0.0,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical Medfusion Model 4000 syringe pump
The Issue: Medfusion Model 4000 syringe infusion pumps, with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter DxU 850m/840m Microscopy Analyzers
The Issue: Beckman Coulter has become aware that the cannula,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iQ200 Series Urine Microscopy Analyzers
The Issue: Beckman Coulter has become aware that the cannula,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iQ Waste Well Adapter
The Issue: Beckman Coulter has become aware that the cannula,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REV 2 Flowcell Capsule Spare
The Issue: Beckman Coulter has become aware that the cannula,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model A710 Intellis Clinician Programmer Application
The Issue: Medtronic has discovered an instance in which the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20
The Issue: Rotating adaptor O-ring manufacturing defect impacting seal integrity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard Operative LAP
The Issue: Surgical convenience kits were manufactured with a component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vortex Surgical ACTU8 FORCEPS
The Issue: Reason for the voluntary recall is residue was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TactiFlex Ablation Sensor Enabled Ablation Catheter
The Issue: When the catheters are used with the EnSiteX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ESG PK CUTTING FORCEPS
The Issue: The jaw may fracture prior to the procedure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.