FDA Medical devices recall ·
Spectrum IQ Product Name: Infusion Pump Model recall
- Recall number
- Z-1368-2026
- Date
- (initiated January 13, 2026)
- Company / brand
- Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
Why was it recalled?
Pumps were released without full testing being performed, including occlusion alarm testing.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599
Distribution
States: Ohio Countries: United States
States: Ohio
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1368-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.