Baxter SIGMA Spectrum infusion pumps recalled for medication delivery failures
Baxter is recalling 146,502 SIGMA Spectrum infusion pumps due to potential medication delivery failures that may occur without alerting clinicians. The issue is linked to administration set setup and occlusion alarm resolution.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. The FDA classification rule requires a minimum score of 4 (Severe). Although no illnesses or deaths are reported in the source text, the potential for medication non-delivery without alerting clinicians poses a serious risk to patient safety.
Plain-English summary
Baxter Healthcare Corporation is recalling the SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2. Approximately 146,502 units have been distributed worldwide, including in the United States, Puerto Rico, St. Thomas, and the countries of Canada, Bahamas, Barbados, Bermuda, Guyana, Jamaica, and Trinidad and Tobago. The recall also includes units distributed to government and military facilities.
There is a potential for reduced or non-delivery of medication when using this pump. In some cases, medication may not be delivered without alerting the user via a pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms.
The FDA classifies this as a Class I recall due to the potential for serious consequences. Healthcare providers and patients using these pumps should contact Baxter Healthcare Corporation for further information and guidance.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- medication-delivery-failure
- alarm-failure
- occlusion-detection-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All serial numbers
- GTIN 00085412498683.
Distribution
Distributed nationwide across the United States.
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