BATTERY FLEX-3S2P 10 — Class II medical device recall Z-0457-2026

Ongoing recall by GE Healthcare Finland Oy, reported 2025-11-19, distributed nationwide. Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lo

Recall number	`Z-0457-2026`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	GE Healthcare Finland Oy, Helsinki, Finland
Recall initiated	2025-09-26
Classified	2025-11-07
Reported by FDA	2025-11-19
Distributed	Nationwide (US)
Quantity	2,857
Serial numbers	`010625-12910`, `010625-12927`, `010625-12958`, `010625-13003`, `010625-13005`, `010625-13029`, `010625-13046`, `010625-13053`, `010625-13154`, `010625-13162`, `010625-13301`, `010625-13302`, `010625-13338`, `010625-13340`, `010625-13399`, `010625-13403`, `010625-13418`, `010625-13421`, `010625-13475`, `010625-13490`, `010625-13596`, `010625-13600`, `010625-13635`, `010625-13795`, `010625-13805` and 475 more
Model numbers	`2062895-001`, `U80296-1R01`

Product

BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S

Reason for recall

Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.

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-0457-2026. 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.