Data Foundry

Medical device recalls 2024

Spectrum Wireless Battery Modules A/B/G/N — Class II medical device recall Z-2582-2024

Ongoing recall by Baxter Healthcare Corporation, reported 2024-08-28, distributed nationwide. The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medic

Recall numberZ-2582-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBaxter Healthcare Corporation, Deerfield, IL, United States
Recall initiated2024-07-17
Classified2024-08-16
Reported by FDA2024-08-28
DistributedNationwide (US)
Quantity17,377 units
Reason classesdevice malfunction, software
UPC / GTIN / UDI-DI00085412498683

Product

Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)

Reason for recall

The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2582-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.