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 22101–22120 of 38,428 recalls

December 20, 2017· Zimmer Biomet, Inc.

Recalled Item: ACE Trochanteric Nail System STER TROC NAIL 125 DEG X

The Issue: Zimmer Biomet is conducting a medical device recall

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

Class II — Potential Health HazardTerminated
December 20, 2017· Zimmer Biomet, Inc.

Recalled Item: ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN

The Issue: Zimmer Biomet is conducting a medical device recall

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

Class II — Potential Health HazardTerminated
December 20, 2017· Zimmer Biomet, Inc.

Recalled Item: ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL

The Issue: Zimmer Biomet is conducting a medical device recall

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

Class II — Potential Health HazardTerminated
December 20, 2017· Boston Scientific Corporation

Recalled Item: SpyScope DS Access and Delivery diagnostic biliary catheter

The Issue: Certain lots of devices may have the working

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

Class II — Potential Health HazardTerminated
December 20, 2017· Philips Electronics North America Corporation

Recalled Item: Allura Xper FD and and Xper FD ORT - Philips

The Issue: Extra monitors, so called 7th or 8th monitor,

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

Class II — Potential Health HazardTerminated
December 20, 2017· Medtronic Neurosurgery

Recalled Item: Model #: CG8900

The Issue: Medtronic is initiating a voluntary recall because the

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

Class II — Potential Health HazardTerminated
December 19, 2017· PerkinElmer Health Sciences, Inc.

Recalled Item: PerkinElmer 226 Sample Collection Device

The Issue: PerkinElmer 226 Sample Collection Devices Lot Number 40020001

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

Class III — Low RiskTerminated
December 19, 2017· Paragon 28, Inc.

Recalled Item: P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy

The Issue: Missing drill guide as stated in the package

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

Class II — Potential Health HazardTerminated
December 19, 2017· Nipro Medical Corporation

Recalled Item: Nipro Blood Tubing set with Priming Set and Transducer Protectors.

The Issue: There is a possibility of the heparin line

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

Class II — Potential Health HazardTerminated
December 19, 2017· Cook Inc.

Recalled Item: Echosight Jansen-Anderson Intratubal Transfer Set

The Issue: Certain lots of in vitro fertilization (IVF) products

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

Class II — Potential Health HazardTerminated
December 19, 2017· Cook Inc.

Recalled Item: Norm-Ject Tuberkulin Syringe

The Issue: Certain lots of in vitro fertilization (IVF) products

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

Class II — Potential Health HazardTerminated
December 19, 2017· Cook Inc.

Recalled Item: 1. SMS Embryo Transfer Set

The Issue: Certain lots of in vitro fertilization (IVF) products

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

Class II — Potential Health HazardTerminated
December 19, 2017· Cook Inc.

Recalled Item: Marrs Laparoscopic GIFT Catheters

The Issue: Certain lots of in vitro fertilization (IVF) products

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

Class II — Potential Health HazardTerminated
December 19, 2017· Ventana Medical Systems Inc

Recalled Item: ultraView Universal DAB Detection Kit

The Issue: Increased reports of leaking and sticking reagent dispensers

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

Class I — Serious Health HazardTerminated
December 19, 2017· Ventana Medical Systems Inc

Recalled Item: Hematoxylin II

The Issue: Increased reports of leaking and sticking reagent dispensers

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

Class I — Serious Health HazardTerminated
December 19, 2017· Ventana Medical Systems Inc

Recalled Item: iView DAB IHC Detection Kit

The Issue: Increased reports of leaking and sticking reagent dispensers

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

Class I — Serious Health HazardTerminated
December 19, 2017· Ventana Medical Systems Inc

Recalled Item: NEXES VEN IVIEW DAB DET KT JPN-US EXPORT

The Issue: Increased reports of leaking and sticking reagent dispensers

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

Class I — Serious Health HazardTerminated
December 19, 2017· Ventana Medical Systems Inc

Recalled Item: CINtec PLUS Cytology Kit (Canada/Japan)

The Issue: Increased reports of leaking and sticking reagent dispensers

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

Class I — Serious Health HazardTerminated
December 19, 2017· Ventana Medical Systems Inc

Recalled Item: ultraView SISH DNP Detection Kit

The Issue: Increased reports of leaking and sticking reagent dispensers

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

Class I — Serious Health HazardTerminated
December 19, 2017· Ventana Medical Systems Inc

Recalled Item: OptiView Amplification Kit

The Issue: Increased reports of leaking and sticking reagent dispensers

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

Class I — Serious Health HazardTerminated