Data Foundry

Medical device recalls 2025

Welch Allyn Connex Vital Signs Monitor — Class II medical device recall Z-1558-2025

Ongoing recall by Baxter Healthcare Corporation, reported 2025-04-23, distributed nationwide. There were customer reports of devices which experienced battery-related fires. The investigation found that t

Recall numberZ-1558-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBaxter Healthcare Corporation, Deerfield, IL, United States
Recall initiated2025-03-24
Classified2025-04-14
Reported by FDA2025-04-23
DistributedNationwide (US)
Quantity228,412 units
Reason classesunapproved product
UPC / GTIN / UDI-DI00732094087512, 00732094087536, 00732094087574, 00732094087581, 00732094087611, 00732094087642, 00732094087673, 00732094087697, 00732094087819, 00732094087833, 00732094087857, 00732094087871, 00732094087895, 00732094088038, 00732094088052, 00732094088076, 00732094088090, 00732094088106, 00732094088120, 00732094088151, 00732094088175, 00732094088182, 00732094088304, 00732094088311, 00732094088359 and 402 more

Product

Welch Allyn Connex Vital Signs Monitor (CVSM):

Reason for recall

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

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-1558-2025. 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.