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 36161–36180 of 38,428 recalls
Recalled Item: CDI Blood Parameter Monitoring System 500 with Arterial blood parameter
The Issue: Terumo discovered through its own testing that CDI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CDI Blood Parameter Monitoring System 500 with Venous blood parameter
The Issue: Terumo discovered through its own testing that CDI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CDI Blood Parameter Monitoring System 500 with Arterial and Venous
The Issue: Terumo discovered through its own testing that CDI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CDI Blood Parameter Monitoring System 500 with Arterial and Venous
The Issue: Terumo discovered through its own testing that CDI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sirtex SIR-yttrium 90 microspheres (Radionuclide)
The Issue: Incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377)....
The Issue: Through investigation of customer complaints, Siemens Healthcare Diagnostics
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to
The Issue: Through investigation of customer complaints, Siemens Healthcare Diagnostics
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is
The Issue: Medtronic has found through device testing that if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to
The Issue: Through investigation of customer complaints, Siemens Healthcare Diagnostics
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vascular Solutions
The Issue: Risk that air may be introduced into the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400
The Issue: Natus Neurology Incorporated is recalling the Nicolet EEG
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge
The Issue: Straight needle labeled as a curved needle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog...
The Issue: Device with Sample Interference Notes (SIN) enabled not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical Incontinence Dish w/ Support Pessary #0
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog...
The Issue: Alere San Diego is recalling the Clearview Mononucleosis
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision
The Issue: LEEP RediKit Products (for use in Loop Electrosurgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical Gellhorn Flexible Pessary 3"
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical Cube Pessary w/Drainage Holes #0"1"
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical Incontinence Dish Folding Pessary #0
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal
The Issue: Incorrect size was printed on the outer product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.