Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall SIGMA Spectrum Infusion Pump

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall SIGMA Spectrum Infusion Pumpsee related information
Date Initiated by FirmNovember 28, 2025
Date PostedJanuary 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1121-2026
Recall Event ID 98167
510(K)NumberK251640 
Product Classification Pump, infusion - Product Code FRN
ProductSIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Code Information 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 2158498 2119695 2143990 2027436 2081647 2090142 2081766 2132604 2087392 2153913 2004327 2064121 2058398 2150299 2047477 2106466 2103333 2019580 2106117 2106656 2106067 2106564 2106420 2104885 2023160 2106359 2010593 2106374 2105913 2105545 2108691 2099348 2106681 2106037 2094532 2108580 2108975 2107820 2108302 2107139 2108206 2107786 2100031 2103850 2105121 2102524 2014666 2106748 2106462 2025115 2119762 2106454 2111211 2111618 2097976 2134941 2151686 2151046 2151529 2161273 2093135 2067637 2106771 2106614 2106346 2013293 2104641 2105103 2023265 2137011 2152466 2110351 2094316 2142410 2125118 2125085 2115234 2152576 2150286 2125804 2152646 2145056 2108479 2090054 2090316 2112969 2104951 2108944 2125978 2011314 2020697 2012966 2034912 2093055 2091740 2093133 2093092 2090317 2112541 2119848 2124307 2156543 2115819 2108948 2068764 2145666 2110655 2011614 2092341 2090701 2015546 2103211 2146805 2122281 2122218 2135223 2155758 2102590 2137864 2141435 2153759 2139827 2108327 2106034 2103539 2105952 2108585 2139489 2093034 2023785 2092572 2092354 2070160 2093511 2147125 2013737 2013659 2084512 2009532 2068987 2109945 2002918 2103807 2068705 2138965 2140482 2089287 2090523 2045838 2090315 2100132 2109849 2104914 2106514 2077283 2152864 2108485 2082000 2009588 2108918 2107006 2108867 2108294 2100633 2107504 2109006 2127015 2028322 2002118 2000826 2106388 2092019 2089942 2107986 2108369 2108019 2108688 2108811 2102241 2094972 2124776 2002102 2134188 2150087 2162168 2004449 2126814 2093171 2025696 2095150 2138751 2026387 2014190 2021933 2025864 2115704 2106410 2019020 2134722 2111304 2089811 2089981 2090078 2089744 2106019 2089179 2089812 2089616 2089384 2134543 2089473 2089864 2089877 2097144 2090760 2085331 2010134 2013108 2013774 2125890 2119667 2112393 2125523 2125871 2127049 2126139 2014015 2005033 2134062 2134353 2050981 2036573 2089880 2090176 2089602 2089828 2152302 2126042 2072755 2158186 2155422 2025404 2069258 2073635 2153030 2156830 2031662 2091629 2093090 2089628 2133878 2089746 2106085 2106759 2122820 2107251 2089873 2089693 2112799 2089872 2084362 2104952 2106505 2117825 2092700 2101923 2017574 2042947 2110079 2147263 2147574 2081129 2139273 2095033 2110320 2093751 2009829 2124379 2135047 2138291 2135425 2133258 2138885 2135929 2154930 2014167 2155581 2161548 2156157 2123007 2106120 2037298 2038167 2107080 2108841 2107636 2091940 2023865 2106347 2106680 2023936 2108240 2112587 2110496 2113253 2112819 2094431 2137887 2096352 2069112 2108202 2145334 2034454 2125684 2004185 2092220 2125289 2148111 2150145 2108600 2103033 2038168 2003675 2110072 2093195 2137800 2105521 2158615 2156191 2148254 2133833 2125655 2146547 2138868 2143606 2150140 2125142 2002778 2019010 2091261
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
1-847-9484770
Manufacturer Reason
for Recall		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 Determined
Cause 2		Nonconforming Material/Component
ActionAn URGENT MEDICAL DEVICE RECALL notification letter dated 11/28/25 was sent to customers. Actions to be Taken by Customers 1. Immediately locate, isolate, and cease all use of the impacted product (see Attachment A for complete list of affected serial numbers). The product code and serial number can be found on the bottom of the infusion pump. 2. If you received this communication directly from Baxter, please acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from Accenture LLP on behalf of Baxter to confirm your receipt of this notification. 3. If you purchased this product from a distributor or wholesaler, please contact them to arrange for return of the affected product. Please note that responding to Baxter is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 4. Please forward a copy of this communication to the director of nursing, director of pharmacy, director of purchasing, facility risk manager, chief of medicine, medical director, office manager, and any other departments within your institution who use the affected product. 5. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a user-level recall of the affected product that you distributed to customers and check the associated box on the customer portal. For general questions regarding this communication, or if you experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867 (select option 1, then option 2) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.
Quantity in Commerce585 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FRN
-
-