SIGMA Spectrum Infusion Pump
Medical device recall Z-1121-2026. Published in FDA’s Enforcement Report on Jan 28, 2026.
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 Jan 28, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 585 units 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
585 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN 00085412498683; Serial Numbers: 2119054 2135735 2132190 2154666 2154656 2096922 2107882 2115820 2116236 2123750 2124467 2142165 2145693 2146570 2135601 2150159 2019614 2030571 2064474 2065875 2007842 2077077 2110000 2139163 2152387…
Every code shown here, 1,997 characters
GTIN 00085412498683; Serial Numbers: 2119054 2135735 2132190 2154666 2154656 2096922 2107882 2115820 2116236 2123750 2124467 2142165 2145693 2146570 2135601 2150159 2019614 2030571 2064474 2065875 2007842 2077077 2110000 2139163 2152387 2090011 2150576 2006741 2090877 2091360 2115605 2136756 2145367 2145911 2144366 2147107 2005818 2036444 2040404 2064488 2054317 2064576 2065380 2064711 2055127 2066486 2065852 2065982 2041955 2081026 2023286 2088106 2089908 2089953 2090012 2096271 2106362 2114760 2114275 2116368 2116054 2117183 2118056 2112866 2136545 2139711 2142076 2161326 2112386 2127356 2161111 2003644 2042815 2089901 2026384 2157334 2004602 2093902 2134816 2155520 2156545 2107252 2136765 2152712 2027178 2135072 2081009 2145203 2156837 2124901 2077354 2077117 2122684 2118643 2106472 2145820 2009374 2115158 2090446 2125551 2150237 2004798 2013799 2023938 2092704 2148207 2096246 2007553 2014364 2089297 2089770 2089790 2119778 2105983 2088857 2140961 2119801 2075390 2013353 2014754 2115703 2105569 2106297 2108307 2107928 2107024 2094331 2010527 2108679 2133529 2133609 2091040 2105718 2138210 2106084 2062517 2022721 2106575 2106357 2106667 2026959 2105921 2098876 2106666 2104788 2106441 2020080 2106646 2106571 2020358 2102437 2106458 2106975 2104537 2026270 2021619 2104636 2105332 2106348 2106213 2019141 2023340 2106243 2100062 2106694 2106468 2106652 2106644 2106687 2104780 2106781 2105011 2105920 2105399 2106661 2106657 2104225 2101214 2020660 2106401 2014906 2104935 2105761 2106381 2106706 2105316 2105830 2102959 2106658 2105682 2128181 2108278 2152865 2139013 2109590 2106397 2105502 2105517 2089502 2085260 2055930 2062659 2031944 2115307 2125787 2151876 2152606 2126978 2163477 2140825 2115351 2037060 2121404 2125165 2093359 2021479 2136589 2156064 2126079 2125854 2011851 2021129 2144675 2127091 2133796 2110399 2106566 2096065 2096542 2127985 2105537 2110489 2106110 2105686 2106565 2105353 2106522 2105857 2111300 2112189 2115454 2102374 2114689 2112238 2106823…
FDA’s list runs to 4,716 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.
US Nationwide distribution.
These words name no state.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 28, 2025.
- FDA classified it on Jan 16, 2026.
- FDA’s Enforcement Report published it on Jan 28, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Baxter Healthcare Corporation, of Deerfield, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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 4,716 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
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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.