Data Foundry

Medical device recalls 2025

Welch Allyn — Class I medical device recall Z-0885-2025

Ongoing recall by Baxter Healthcare Corporation, reported 2025-01-22, distributed nationwide. There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the a

Recall numberZ-0885-2025
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBaxter Healthcare Corporation, Deerfield, IL, United States
Recall initiated2024-12-20
Classified2025-01-16
Reported by FDA2025-01-22
DistributedNationwide (US)
Quantity946 units
UPC / GTIN / UDI-DI00120190000090, 00120280000368, 00120280000979, 00120290001096, 00120290001195, 00120300000033, 00120300000064, 00120300000071, 00120300000613, 00120300000859, 00120310000665, 00120310000702, 00120310000733, 00120310001143, 00120310001570, 00120310001624, 00120320000099, 00120320000105, 00120330000935, 00120340000086, 00120340000321, 00120340000338, 00120340000345, 00120340000543, 00120340001021 and 73 more
Serial numbers120190000085, 120190000090, 120190000707, 120190000713, 120190000714, 120190000730, 120210000714, 120210000719, 120210000740, 120210000744, 120210000756, 120210000759, 120210000760, 120210000884, 120210001610, 120270001439, 120270001446, 120270001452, 120270001453, 120270001455, 120270001469, 120270001478, 120280000212, 120280000218, 120280000241 and 475 more
Model numbersBT-20-0002A

Product

Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A

Reason for recall

There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

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-0885-2025. 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.