Class I recallOngoing

Baxter Sigma Spectrum Infusion System (V6 Platform) recall — FDA event 96289

FDA · FDA event 96289 · Posted Mar 6, 2025

Published Mar 6, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

Baxter issued an "URGENT MEDICAL DEVICE RECAL" notice to its consignees on 02/05/2025 via US Mail. The notice explained the issue, hazard involved, and requested the following actions be taken: "1. Immediately locate, isolate, and cease all use of Spectrum pumps with the affected serial numbers. The product code and serial number can be found on the bottom of the infusion pump. 2. Contact Baxter to arrange for the return of the affected pumps for inspection and reservicing as applicable. 3. If you received this communication directly from Baxter, acknowledge receipt on the enclosed reply form even if you have no remaining inventory. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 5. Please forward a copy of this communication to all departments within your institution who use the affected product. 6. 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 quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867 Monday through Friday, between 7:00 am and 7:00 pm Eastern Time."

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Baxter Sigma Spectrum Infusion System (V6 Platform) by Baxter Healthcare Corporation.

Products affected by FDA event 96289
Model	Description	Lot / serial range	Manufactured	Status
Z-1253-2025	Z-1253-2025	UDI/DI 00085412091570, Serial Numbers: 704198, 728888, 751492, 758399, 758614, 761662, 763197, 766291, 772611, 773302, 775486, 778837, 785425, 793453, 795240, 798065, 814485, 818850, 826637, 850214, 850854, 851500, 854157, 855803, 863354, 870307, 873114, 876483, 877014, 877102, 889153, 896292, 900181, 906422, 907176, 912242, 913562, 927864, 938265, 958176, 962828, 963975, 965158, 974676, 981605, 982459, 984154, 986132, 986634, 989053, 993087, 994417, 994842, 995538, 997153, 1006359, 1011058, 1013925, 1014064, 1014529, 1014856, 1017150, 1017546, 1018229, 1018703, 1024109	Not provided in the normalized record	Ongoing
Z-1254-2025	Z-1254-2025	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	Not provided in the normalized record	Ongoing

Distribution: US: Nationwide
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Feb 5, 2025
Recall initiated
Date recorded by the FDA.
Mar 6, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 96289
Published: Mar 6, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Baxter Sigma Spectrum Infusion System (V6 Platform) recall — FDA event 96289

FDA · FDA event 96289 · Posted Mar 6, 2025

Published Mar 6, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists Baxter Sigma Spectrum Infusion System (V6 Platform) by Baxter Healthcare Corporation.

Products affected by FDA event 96289
Model	Description	Lot / serial range	Manufactured	Status
Z-1253-2025	Z-1253-2025	UDI/DI 00085412091570, Serial Numbers: 704198, 728888, 751492, 758399, 758614, 761662, 763197, 766291, 772611, 773302, 775486, 778837, 785425, 793453, 795240, 798065, 814485, 818850, 826637, 850214, 850854, 851500, 854157, 855803, 863354, 870307, 873114, 876483, 877014, 877102, 889153, 896292, 900181, 906422, 907176, 912242, 913562, 927864, 938265, 958176, 962828, 963975, 965158, 974676, 981605, 982459, 984154, 986132, 986634, 989053, 993087, 994417, 994842, 995538, 997153, 1006359, 1011058, 1013925, 1014064, 1014529, 1014856, 1017150, 1017546, 1018229, 1018703, 1024109	Not provided in the normalized record	Ongoing
Z-1254-2025	Z-1254-2025	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	Not provided in the normalized record	Ongoing

Distribution

US: Nationwide

Units affected

See official FDA record

ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallCompleted

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

FDA · FDA event 99063Posted Jun 25, 2026

Class II recallOngoing

Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

FDA · FDA event 98872Posted Jun 5, 2026

Baxter Sigma Spectrum Infusion System (V6 Platform) recall — FDA event 96289

Follow Baxter Sigma Spectrum Infusion System (V6 Platform)

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Baxter Sigma Spectrum Infusion System (V6 Platform) recall — FDA event 96289

Follow Baxter Sigma Spectrum Infusion System (V6 Platform)

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline