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 1541–1560 of 38,428 recalls
Recalled Item: Boston Scientific UroMax Ultra Kit
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Encore 26 Inflation Device
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Encore Advantage Kit
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number:
The Issue: Packaging failures were identified which could lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CVS Honey Pad Product Name: CVS Honey Pad
The Issue: Packaging failures were identified which could lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing
The Issue: Packaging failures were identified which could lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with
The Issue: Packaging failures were identified which could lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620
The Issue: Packaging failures were identified which could lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog
The Issue: Packaging failures were identified which could lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet
The Issue: Packaging failures were identified which could lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog
The Issue: Packaging failures were identified which could lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PhD Hemostasis Valve
The Issue: Hemostasis valve has a manufacturing defect and when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxC 500 AU Module w/ISE
The Issue: On a clinical analyzer, when ordering a Clinical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers
The Issue: Two new potential laser safety failure modes have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard
The Issue: for open header bag seals, compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard
The Issue: for open header bag seals, compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novum IQ Syringe Pump
The Issue: Baxter Healthcare Corporation is issuing an Urgent Medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novum IQ LVP (Large Volume Pump)
The Issue: Baxter Healthcare Corporation is issuing an Urgent Medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novum IQ Syringe Pump
The Issue: Baxter Healthcare Corporation is issuing an Urgent Medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x
The Issue: Philips Azurion and Allura systems configured with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.