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 16981–17000 of 38,428 recalls
Recalled Item: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
The Issue: need for device replacement - Elective Replacement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray NGDS Warrior Panel
The Issue: The firm has identified that an incorrect instruction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
The Issue: Unintended ferrous material may be present within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829
The Issue: Unintended ferrous material may be present within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525
The Issue: Unintended ferrous material may be present within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
The Issue: Unintended ferrous material may be present within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
The Issue: Unintended ferrous material may be present within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
The Issue: Unintended ferrous material may be present within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828
The Issue: Unintended ferrous material may be present within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci SP Camera
The Issue: Some cameras were found to have residual soil
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RespVent Closed Suction System T-Piece Tracheostomy Adult
The Issue: It has been determined that some units of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the
The Issue: Binding can occur between the attachment bolt and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the
The Issue: Binding can occur between the attachment bolt and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing...
The Issue: Interference can occur between the adolescent attachment bolt
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FACSLyric Flow Cytometer
The Issue: Flow cytometers, when used with specific tubes may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FACSLyric Flow Cytometer
The Issue: Flow cytometers, when used with specific tubes may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FACSLyric Flow Cytometer
The Issue: Flow cytometers, when used with specific tubes may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FACSLyric Flow Cytometer
The Issue: Flow cytometers, when used with specific tubes may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FACSLyric Flow Cytometer
The Issue: Flow cytometers, when used with specific tubes may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.