FDA Device recall Z-1121-2026
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
- FDA Device
- Class II
- ongoing
- Published 2026-01-28
On 2026-01-28 the FDA classified a Class II recall of SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 by Baxter Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1121-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-28 |
| Published | 2026-01-28 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Reason
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.
Identifiers
| code_info | GTIN 00085412498683; Serial Numbers: 2119054 2135735 2132190 2154666 2154656 2096922 2107882 2115820 2116236 2123750 21…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 211 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1121-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.