Severity
Moderate
FDA Devices recall · Reported February 25, 2015
Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.
Cincinnati Sub-Zero Products Inc recalled Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used … - a moderate-severity action.
Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used … was recalled by Cincinnati Sub-Zero Products Inc in February 25, 2015. Reason: Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water le…. Check the official notice for the remedy. Verify recall #Z-1129-2015 with the FDA Devices before acting.
The recall
Cincinnati Sub-Zero Products Inc issued this moderate-severity FDA Devices recall-Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water le….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1129-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1129-2015) was formally reported on February 25, 2015, with the manufacturer initiating the action on January 7, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Cincinnati Sub-Zero Products Inc is listed as the recalling firm, operating out of Cincinnati, OH. Federal records list the affected scope as 1390.
The documented reason for this recall is: Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak. Distribution data in the federal record shows the product reached: Nationwide Distribution including FL, IL, TN, GA, VA, MO, NM, WI, MI, NC, IN, OH, MA, CA, WA, PA, KY, MD, HI, and AL.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
1390
Related Recalls
6
3 from same agency
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.
Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1129-2015 |
| Date reported | February 25, 2015 |
| Date initiated | January 7, 2015 |
| Recalling firm | Cincinnati Sub-Zero Products Inc |
| Firm location | Cincinnati, OH |
| Affected scope | 1390 |
| Distribution | Nationwide Distribution including FL, IL, TN, GA, VA, MO, NM, WI, MI, NC, IN, OH, MA, CA, WA, PA, KY, MD, HI, and AL. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 25, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.