FDA Device recall Z-1254-2025
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
- FDA Device
- Class I
- ongoing
- Published 2025-03-12
On 2025-03-12 the FDA classified a Class I recall of Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 by Baxter Healthcare, citing there is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1254-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-02-05 |
| Published | 2025-03-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Reason
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Identifiers
| code_info | UDI/DI 00085412610900, Serial Numbers: 3020290, 3020992, 3020996, 3021929, 3023080, 3023183, 3023537, 3023758, 3500529…UDI/DI 00085412610900, Serial Numbers: 3020290, 3020992, 3020996, 3021929, 3023080, 3023183, 3023537, 3023758, 3500529, 3502799, 3502864, 3510806, 3511639, 3512647, 3514801, 3516888, 3517399, 3517517, 3518558, 3519053, 3564064, 3564818, 3565462, 3565620, 3566022, 3566254, 3567145, 3567218, 3567998, 3568527, 3568922, 3570910, 3571100, 3571598, 3571972, 3573147, 3573504, 3574293, 3575033, 3575107, 3576026, 3576443, 3656732, 3657316, 3657541, 3657814, 3657821, 3657995, 3659259, 3660176, 3660244, 3662986, 3664495, 3665624, 3721608, 3721910, 3721946, 3722620, 3723725, 3724211, 3730270, 3730408, 3732309, 3732476, 3734858, 3735010, 3735261, 3735734, 3738122, 3744219, 3744455, 3746159, 3746749, 3749111, 3749929, 3764591, 3767418, 3519969, 3520138, 3520706, 3520746, 3520829, 3521120, 3521338, 3606099, 3607097, 3607681, 3608730, 3609223, 3610668, 3610820, 3611120, 3611140, 3611650, 3612298, 3612886, 3613052, 3614035, 3615599, 3615816, 3616449, 3666443, 3666451, 3667116, 3668076, 3668654, 366885 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1254-2025%22
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