T/Pump temperature therapy pump — Class III medical device recall Z-1013-2018
Terminated recall by Stryker Medical Division of Stryker Corporation, reported 2018-03-21, distributed nationwide. The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature
| Recall number | Z-1013-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Medical Division of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2017-11-07 |
| Classified | 2018-03-14 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2019-04-09 |
| Distributed | Nationwide (US) |
| Quantity | 9,902 |
| UPC / GTIN / UDI-DI | 00201700920425, 02016009100038, 02016009100045, 02016009100052, 02016009100069, 02016009100076, 02016009100083, 02016009100090, 02016009100106, 02016009100113, 02016009100120, 02016009100137, 02016009100144, 02016009100151, 02016009100168, 02016009100175, 02016009100182, 02016009100199, 02016009100205, 02016009100212, 02016009100229, 02016009100236, 02016009100243, 02016009100250, 02016009100267 and 466 more |
| Model numbers | TP700, TP700C |
Product
T/Pump temperature therapy pump, Models TP700 and TP700C
Reason for recall
The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenance to the Indications for Use statement.
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-1013-2018. 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.