T/Pump temperature therapy pump, Models TP700 and TP700C

Recall Insight

This FDA Devices action (record #Z-1013-2018) was formally reported on March 21, 2018, with the manufacturer initiating the action on November 7, 2017. It is classified under Low severity (Class III), with a current status of Terminated. Stryker Medical Division of Stryker Corporation is listed as the recalling firm, operating out of Portage, MI. Federal records indicate 9902 units are affected.

The documented reason for this recall is: 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 data in the federal record shows the product reached: Distributed in all 50 states, the District of Columbia, and Guam.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.