The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0457-2026·Announced 2025-11-19

Monitor batteries recalled because they can lose the ability to charge

GE Healthcare is recalling 2,857 FLEX-3S2P lithium-ion batteries used with patient monitors because they can lose the capability to hold charge and provide backup power.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: loss of patient monitoring can delay recognition of a deteriorating patient, and no injuries are reported.

Plain-English summary

The BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS, model 2062895-001, manufacturer part number U80296-1R01 revision S, used with affected patient monitors, is being recalled.

The firm describes a potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose the capability to hold charge and provide backup power. If this occurs, it will cause loss of patient monitoring and potentially delay recognising patient status changes requiring treatment.

The recall covers 2,857 units. The record notes there is no UDI, and affected units are identified by a manufacturing date range printed under the date of manufacture symbol. Distribution was worldwide including nationwide in the United States. The FDA has classified the action as Class II.

Sites using these batteries should follow GE Healthcare's instructions.

The recalled product

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
Manufacturer
GE Healthcare Finland Oy
Category
Medical Device — Monitor accessory
Hazard
Affected units
2,857

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • No UDI Manufacturing date range (YYYY-MM-DD date format
  • located underneath date of manufacture symbol): 2024-11-25 - 2025-05-31

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by GE Healthcare Finland Oy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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