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 35701–35720 of 38,428 recalls

May 10, 2013· Symbios Medical Products, LLC

Recalled Item: Part 510490 Disposable Infusion Pump

The Issue: Symbios Medical Products, Indianapolis, Indiana, is performing a

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

Class I — Serious Health HazardTerminated
May 10, 2013· Symbios Medical Products, LLC

Recalled Item: Part510447 Disposable Infusion Pump

The Issue: Symbios Medical Products, Indianapolis, Indiana, is performing a

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

Class I — Serious Health HazardTerminated
May 10, 2013· Symbios Medical Products, LLC

Recalled Item: Part 510450 Disposable Infusion Pump

The Issue: Symbios Medical Products, Indianapolis, Indiana, is performing a

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

Class I — Serious Health HazardTerminated
May 10, 2013· Symbios Medical Products, LLC

Recalled Item: Part 510076 Disposable Dual Infusion Pump

The Issue: Symbios Medical Products, Indianapolis, Indiana, is performing a

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

Class I — Serious Health HazardTerminated
May 10, 2013· Symbios Medical Products, LLC

Recalled Item: Part 510121 Disposable Infusion Pump

The Issue: Symbios Medical Products, Indianapolis, Indiana, is performing a

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

Class I — Serious Health HazardTerminated
May 10, 2013· Symbios Medical Products, LLC

Recalled Item: Part 510613 Disposable Infusion Pump

The Issue: Symbios Medical Products, Indianapolis, Indiana, is performing a

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

Class I — Serious Health HazardTerminated
May 10, 2013· Symbios Medical Products, LLC

Recalled Item: Part 510613 Disposable Infusion Pump

The Issue: Symbios Medical Products, Indianapolis, Indiana, is performing a

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

Class I — Serious Health HazardTerminated
May 10, 2013· Symbios Medical Products, LLC

Recalled Item: Part 510031 Disposable Single Infusion Pump

The Issue: Symbios Medical Products, Indianapolis, Indiana, is performing a

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

Class I — Serious Health HazardTerminated
May 9, 2013· Novarad Corporation

Recalled Item: NovaPACS  versions 7.4

The Issue: for images to be flipped while streaming,

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

Class II — Potential Health HazardTerminated
May 9, 2013· Integra LifeSciences Corporation

Recalled Item: Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal

The Issue: As a result of the investigation into an

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

Class II — Potential Health HazardTerminated
May 9, 2013· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products CRP Slides (Reagent)

The Issue: While performing interval testing Ortho Clinical Diagnostics (OCD)

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

Class III — Low RiskTerminated
May 9, 2013· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products K+ (Potassium) Slides (Reagent)

The Issue: While performing interval testing, Ortho Clinical Diagnostics (OCD)

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

Class III — Low RiskTerminated
May 9, 2013· ConBio, a CynoSure Company

Recalled Item: Multilite Dye Handpieces

The Issue: An inconsistency was identified related to electronic display

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

Class II — Potential Health HazardTerminated
May 9, 2013· GE Healthcare, LLC

Recalled Item: GE Healthcare

The Issue: GE Healthcare has recently become aware of a

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

Class II — Potential Health HazardTerminated
May 8, 2013· Verathon, Inc.

Recalled Item: GlideScope Video Laryngoscope (GVL) 3

The Issue: Verathon GlideScope Reusable GVL and AVL Blades are

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

Class I — Serious Health HazardTerminated
May 8, 2013· Intuitive Surgical, Inc.

Recalled Item: 8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and

The Issue: Intuitive Surgical has identified a potential for some

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

Class II — Potential Health HazardTerminated
May 8, 2013· Intuitive Surgical, Inc.

Recalled Item: 8mm Maryland Bipolar Forceps used in conjunction with the da

The Issue: Reports of dislodging of the Cautery Plug Insert

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

Class II — Potential Health HazardTerminated
May 8, 2013· Intuitive Surgical, Inc.

Recalled Item: 8mm Precise Bipolar Forceps used in conjunction with the da

The Issue: Reports of dislodging of the Cautery Plug Insert

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

Class II — Potential Health HazardTerminated
May 8, 2013· Intuitive Surgical, Inc.

Recalled Item: 8mm Fenestrated Bipolar Forceps used in conjunction with the da

The Issue: Reports of dislodging of the Cautery Plug Insert

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

Class II — Potential Health HazardTerminated
May 8, 2013· DePuy Orthopaedics, Inc.

Recalled Item: DePuy LifeLiner Stick & Cut Resistant Gloves Rt

The Issue: LifeLiner Stick and Cut Resistant Gloves are being

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

Class III — Low RiskTerminated