Cincinnati Sub-Zero Products LLC, a Gentherm Company: Medical Device Recall in 2019 - (Recall #: Z-2291-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.

Product Classification:

Class III

Date Initiated: July 19, 2019

Date Posted: August 28, 2019

Recall Number: Z-2291-2019

Event ID: 83387

Reason for Recall:

Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage

Status: Terminated

Product Quantity: 2079 units

Code Information:

Serial Numbers 141-LT-02789 through 193-LT-05137 UDI: 10613031881165

Distribution Pattern:

Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES

Voluntary or Mandated:

Voluntary: Firm initiated