Data Foundry

Medical device recalls 2015

Cold Therapy Pad — Class II medical device recall Z-1129-2015

Terminated recall by Cincinnati Sub-Zero Products Inc, reported 2015-02-25, distributed nationwide. Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water lea

Recall numberZ-1129-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCincinnati Sub-Zero Products Inc, Cincinnati, OH, United States
Recall initiated2015-01-07
Classified2015-02-19
Reported by FDA2015-02-25
Terminated2015-06-19
DistributedNationwide (US)
Quantity1,390
Reason classespackaging
Lot numbers13380, 13390, 13418
Model numbers50137

Product

Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.

Reason for recall

Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1129-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.