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.

38,428 total recalls
0 this month

Showing 25761–25780 of 38,428 recalls

October 27, 2016· Teleflex Medical

Recalled Item: LMA MADomizer

The Issue: Product Defect; These products may produce a straight

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 27, 2016· Teleflex Medical

Recalled Item: LMA MADdy

The Issue: Product Defect; These products may produce a straight

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 27, 2016· Teleflex Medical

Recalled Item: LMA MADett

The Issue: Product Defect; These products may produce a straight

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 27, 2016· Teleflex Medical

Recalled Item: FLEXI NOZZLE LONG

The Issue: Product Defect; These products may produce a straight

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 27, 2016· Teleflex Medical

Recalled Item: FLEXI NOZZLE SHORT Product Usage: These products are used for

The Issue: Product Defect; These products may produce a straight

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 27, 2016· Teleflex Medical

Recalled Item: LMA MADgic

The Issue: Product Defect; These products may produce a straight

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 27, 2016· Olympus Scientific Solutions Americas

Recalled Item: Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA...

The Issue: unintentional x-ray emission after users attempt early

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 26, 2016· Diagnostic Hybrids, Inc.

Recalled Item: Quidel MicroVue Intact PTH EIA

The Issue: There may be a loss of separation between

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskTerminated
October 26, 2016· Ortho-Clinical Diagnostics

Recalled Item: VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250

The Issue: CRP samples diluted using VITROS Chemistry Products Specialty

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskTerminated
October 26, 2016· 3M Company - Health Care Business

Recalled Item: 3M Universal Electrosurgical Pad

The Issue: 3M is recalling Universal Electrosurgical Pads because a

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 26, 2016· Atrium Medical Corporation

Recalled Item: Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended

The Issue: Trocar Catheters are packaged with a label containing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 26, 2016· Atrium Medical Corporation

Recalled Item: Atrium Medical 8 Fr Trocar catheter

The Issue: Trocar Catheters are packaged with a label containing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 26, 2016· Atrium Medical Corporation

Recalled Item: Atrium Medical 32 Fr Trocar catheter

The Issue: Trocar Catheters are packaged with a label containing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 26, 2016· Atrium Medical Corporation

Recalled Item: Atrium Medical 20 Fr Trocar catheter

The Issue: Trocar Catheters are packaged with a label containing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 26, 2016· Atrium Medical Corporation

Recalled Item: Atrium Medical 10 Fr Trocar catheter

The Issue: Trocar Catheters are packaged with a label containing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 26, 2016· Atrium Medical Corporation

Recalled Item: Atrium Medical 28 Fr Trocar catheter

The Issue: Trocar Catheters are packaged with a label containing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 26, 2016· Atrium Medical Corporation

Recalled Item: Atrium Medical 12 Fr Trocar catheter

The Issue: Trocar Catheters are packaged with a label containing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 26, 2016· Atrium Medical Corporation

Recalled Item: Atrium Medical 24 Fr Trocar catheter

The Issue: Trocar Catheters are packaged with a label containing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 25, 2016· MED-EL Elektromedizinische Gereate, Gmbh

Recalled Item: SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery

The Issue: Unit Defect: Firm inspection revealed units did not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
October 25, 2016· Smiths Medical ASD, Inc.

Recalled Item: NORMFlow H-110 Irrigation Fluid Warmer

The Issue: Smiths Medical became aware that that one (1)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated