T/Pump temperature therapy pump, Models TP700 and TP700C
Medical device recall Z-1013-2018. Published in FDA’s Enforcement Report on Mar 21, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 21, 2018. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 9902 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
T/Pump temperature therapy pump, Models TP700 and TP700C
9902, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
TP700CI51006 TP700CI51013 TP700A61786 TP700A61803 TP700A61810 TP700A61754 TP700A61794 TP700A61802 TP700A61808 TP700A61811 TP700A61822 TP700B61158 TP700B61018 TP700B61033 TP700B61121 TP700B61122 TP700B61128 TP700B61131 TP700B61133…
Every code shown here, 1,988 characters
TP700CI51006 TP700CI51013 TP700A61786 TP700A61803 TP700A61810 TP700A61754 TP700A61794 TP700A61802 TP700A61808 TP700A61811 TP700A61822 TP700B61158 TP700B61018 TP700B61033 TP700B61121 TP700B61122 TP700B61128 TP700B61131 TP700B61133 TP700B61134 TP700B61135 TP700B61139 TP700B61140 TP700B61142 TP700B61145 TP700B61146 TP700B61152 TP700B61162 TP700CH51109 TP700CH51116 TP700CI51002 TP700A61807 TP700A61792 TP700A61804 TP700A61813 TP700A61814 TP700A61815 TP700A61821 TP700A61823 TP700A61824 TP700A61829 TP700A61831 TP700A61837 TP700A61839 TP700A61842 TP700A61844 TP700CH51108 TP700A61654 TP700A61695 TP700A61696 TP700A61697 TP700A61700 TP700A61702 TP700A61704 TP700A61798 TP700A61817 TP700A61819 TP700A61820 TP700A61827 TP700A61828 TP700A61830 TP700A61832 TP700A61834 TP700A61835 TP700A61840 TP700A61699 TP700A61701 TP700A61720 TP700A61723 TP700A61731 TP700A61733 TP700C61078 TP700C61308 TP700C61316 TP700C61504 TP700C61546 TP700C61548 TP700C61549 TP700C61552 TP700C61570 TP700C61582 TP700C61592 TP700C61611 TP700C61615 TP700C61617 TP700A61655 TP700A61657 TP700A61669 TP700A61671 TP700A61672 TP700A61673 TP700A61687 TP700A61694 TP700A61703 TP700A61705 TP700A61706 TP700A61707 TP700A61708 TP700A61709 TP700A61710 TP700A61711 TP700A61712 TP700A61715 TP700A61718 TP700A61719 TP700A61722 TP700C61116 TP700C61126 TP700C61131 TP700C61141 TP700C61145 TP700C61182 TP700C61532 TP700C61543 TP700C61551 TP700C61571 TP700C61610 TP700C61620 TP700C61572 TP700C61583 TP700C61584 TP700C61590 TP700C61591 TP700C61594 TP700C61595 TP700C61601 TP700C61602 TP700C61603 TP700C61606 TP700C61607 TP700C61613 TP700C61614 TP700C61622 TP700C61121 TP700C61122 TP700C61132 TP700C61134 TP700C61139 TP700C61149 TP700C61152 TP700C61101 TP700C61123 TP700C61125 TP700C61127 TP700C61128 TP700C61130 TP700C61140 TP700C61142 TP700C61150 TP700C61151 TP700C61110 TP700C61113 TP700C61118 TP700C61144 TP700C61146 TP700C61147 TP700C61148 TP700C61171 TP700C61172 TP700C61173 TP700C61183 TP700C61184 TP700C61186 TP700CH51095 TP700CH51107…
FDA’s list runs to 247,984 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Distributed in all 50 states, the District of Columbia, and Guam.
The states and territories these words name
- District of Columbia
- Guam
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 7, 2017.
- FDA classified it on Mar 14, 2018.
- FDA’s Enforcement Report published it on Mar 21, 2018.
- FDA terminated it on Apr 9, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Medical Division of Stryker Corporation, of Portage, MI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 247,984 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.