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 10621–10640 of 38,428 recalls
Recalled Item: MEDLINE Polyurethane Foam Bedside Cleaning Kit
The Issue: Sporadic reports were received of discoloration on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PX200 Emergency Relief Bed
The Issue: Product label was printed without the UDI number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oakworks Bed (Emergency Field Bed)
The Issue: The warning label was printed with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 15 Liters Drain Bag
The Issue: Certain Peritoneal Dialysis product codes do not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3
The Issue: Certain Peritoneal Dialysis product codes do not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APD Drain Manifold
The Issue: Certain Peritoneal Dialysis product codes do not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE Polyurethane Foam Bedside Cleaning Kit
The Issue: Sporadic reports were received of discoloration on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Locking Cap for PD Catheter Adapter
The Issue: Certain Peritoneal Dialysis product codes do not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE Polyurethane Bedside Cleaning Kit
The Issue: Sporadic reports were received of discoloration on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5 Prong Manifold Set (with Luer Connectors)
The Issue: Certain Peritoneal Dialysis product codes do not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE Polyurethane Foam Bedside Cleaning Kit
The Issue: Sporadic reports were received of discoloration on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Effluent Sample Bag
The Issue: Certain Peritoneal Dialysis product codes do not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge
The Issue: Sporadic reports were received of discoloration on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
The Issue: Incorrect adhesive used to secure the diopter ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
The Issue: Incorrect adhesive used to secure the diopter ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
The Issue: Incorrect adhesive used to secure the diopter ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus235- Proton Therapy System: to produce and deliver a proton
The Issue: First layer of Uniform Scanning treatment fields is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The C304-HIS device features a guide wire to access the vein
The Issue: The firm's internal processes identified that certain lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System
The Issue: Firm detected an increase in complaints related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: TEG5000 Analyzer (07-022
The Issue: When the TEG 5000 Analyzer including TEG Analytical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.