Food, drugs, devices › Stryker Medical Division of Stryker Corporation
Device recall: T/Pump temperature therapy pump, Models TP700 and TP700C
Stryker Medical Division of Stryker Corporation (Portage, MI) initiated this device recall on 7 Nov 2017; FDA lists 1 product record under event 79302, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 9 Apr 2019. Initiation: voluntary: firm initiated. Stryker Medical Division of Stryker Corporation has 37 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Stryker Medical Division of Stryker Corporation, Portage, MI.
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."
Distribution
"Distributed in all 50 states, the District of Columbia, and Guam."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1013-2018 | T/Pump temperature therapy pump, Models TP700 and TP700C | 9902 | Class III | Terminated | 21 Mar 2018 |
Context
Other enforcement events for Stryker Medical Division of Stryker Corporation
All 37 events for Stryker Medical Division of Stryker Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed in all 50 states, the District of Columbia, and Guam."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Apr 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.