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 4981–5000 of 38,428 recalls
Recalled Item: MRI systems: Vantage Orian MRT-1550 (MEXL-1550)
The Issue: The terminal block used to secure the power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in
The Issue: Issue on a specific packaging machine resulted in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MONOCRYL (poliglecaprone 25) Suture - Intended for use in general
The Issue: Issue on a specific packaging machine resulted in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VICRYL (polyglactin 910) Suture - Indicated for use in general
The Issue: Issue on a specific packaging machine resulted in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDS II (polydioxanone) Suture - Intended for use in general
The Issue: Issue on a specific packaging machine resulted in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use
The Issue: Issue on a specific packaging machine resulted in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xstar Safety Slit Knife
The Issue: The wrong configuration of the blade was in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use
The Issue: Issue on a specific packaging machine resulted in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xstar Safety Slit Knife
The Issue: The wrong configuration of the blade was in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IBA Proton Therapy System - PROTEUS 235 - Designed to
The Issue: Irradiation is not interrupted when some C230 Accelerator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric
The Issue: Products in distribution were found by FDA to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml
The Issue: Products in distribution were found by FDA to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syringes with Low Dead Space labeled as: a) SOL-M 1ml
The Issue: Products in distribution were found by FDA to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml
The Issue: Products in distribution were found by FDA to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M
The Issue: Products in distribution were found by FDA to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap
The Issue: Products in distribution were found by FDA to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kosmos on iOS impacting iOS
The Issue: Ultrasound system has a bug in affected iOS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: First Source Vision M. Portable cart and platform that supports
The Issue: for the bolt that secures the positioning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: First Source iQ Flex M. Portable cart and platform that
The Issue: for the bolt that secures the positioning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Hoffman LRF Wire Tensioner
The Issue: The adjustment ring on the device may become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.