Covidien LLC: Medical Device Recall in 2015 - (Recall #: Z-2443-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling

Product Classification:

Class II

Date Initiated: July 31, 2015

Date Posted: September 2, 2015

Recall Number: Z-2443-2015

Event ID: 71784

Reason for Recall:

Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations

Status: Terminated

Product Quantity: 68,800 units

Code Information:

Lot Codes: 312209X 313033X 313304X 314307X 315108X 318417X 322119X 322514X 322817X

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated