Class II U.S. Food and Drug Administration

GE Healthcare Finland Oy Battery Flex-3S2P 10.8V 18650 Li-Ion Smbus used recall: Potential loss of monitoring on affected monitors when powered by certain

Recall published 11 months ago

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.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0457-2026
Published
November 19, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
GE Healthcare Finland Oy
Product type
Medical devices
Units affected
2857
Distribution
Nationwide
Made in
Finland
Lot / code info
No UDI Manufacturing date range (YYYY-MM-DD date format, located underneath date of manufacture symbol): 2024-11-25 - 2025-05-31; 2025-07-07 Serial Nos. 021725-20339 021725-22682 120924-06125 120924-05011 120924-05830 120924-03583 120924-04467 120924-04447 031425-28687 120924-04436 120924-04240 021725-21549 021725-20604 5567418-SO-1-1 031425-30157 031425-28597 031425-29489 031425-28901 031425-28978 031425-28590 031425-29484 031425-29177 021725-21521 021725-20357 021725-20412 021725-22331 120924-04465 120924-07616 120924-07484 120924-07792 120924-07909 120924-07359 120924-07524 120924-06997 120924-07861 120924-08477 120924-07878 120924-07726 120924-07799 120924-08618 120924-07791 120924-08527 120924-07862 120924-08616 120924-08622 031425-29009 031425-28366 031425-30139 031425-28758 031425-29924 031425-29879 031425-28136 031425-29340 031425-29934 031425-28144 031425-28970 031425-29883 031425-28120 031425-27976 031425-29349 031425-28713 031425-28188 021725-22330 021725-21579 021725-21271 021725-20338 021725-20573 021725-21576 021725-22607 021725-20579 021725-22599 021725-21251 010625-13475 021725-22701 120924-05740 031425-28162 031425-29868 031425-28705 031425-29295 031425-29944 031425-29899 022625-25420 022625-26187 022625-25158 022625-26232 022625-26208 022625-26814 022625-26256 022625-26220 022625-26867 022625-26890 031425-28985 031425-30149 120924-04966 120924-04244 120924-06139 120924-08030 120924-05493 120924-07728 120924-05393 120924-04387 120924-05428 120924-06013 120924-04841 120924-08550 120924-06003 120924-06135 120924-04210 021725-22415 031425-30066 031425-28908 031425-28289 031425-28010 031425-29583 031425-28980 031425-30088 031425-28467 031425-28402 031425-28164 031425-28699 031425-28036 031425-29029 031425-29593 031425-29205 031425-28994 031425-29211 031425-28425 031425-28051 031425-28130 031425-29646 031425-28424 031425-28446 031425-29630 031425-27842 031425-29012 031425-27815 031425-28055 031425-29897 031425-28768 031425-28749 031425-29054 031425-28157 031425-29359 031425-29139 031425-28760 031425-29316 031425-29925 031425-29875 031425-28723 031425-29962 031425-29328 031425-29904 031425-29298 031425-29957 031425-28165 031425-28716 031425-29932 031425-29156 031425-29753 031425-29905 031425-28170 031425-29354 031425-29233 031425-28692 031425-28138 031425-28770 031425-28693 021725-20387 021725-20415 021725-21314 021725-22700 021725-20584 120924-04199 120924-04922 031425-29613 031425-27829 120924-06022 031425-29461 031425-28006 031425-28581 031425-28589 031425-28986 031425-30165 031425-29582 031425-28899 031425-28898 031425-28582 031425-29550 031425-29173 031425-30154 031425-28902 031425-28337 031425-28910 031425-28022 031425-29894 031425-29908 031425-29249 031425-29284 031425-28134 031425-27816 031425-28135 031425-28696 031425-29014 031425-28436 031425-27817 031425-29202 031425-28600 031425-29614 031425-28394 031425-28585 031425-29350 010625-14241 010625-15358 010625-13996 010625-15453 010625-15073 010625-15218 010625-13945 010625-13863 010625-14254 010625-14512 120924-06097 120924-06115 120924-06205 120924-05369 120924-05975 120924-05910 120924-06106 120924-06085 120924-06082 120924-05886 120924-06211 120924-06356 120924-06239 120924-03923 120924-05624 120924-05371 120924-06105 120924-05924 120924-05634 120924-05380 020625-17686 020625-18546 031425-28556 020625-17694 020625-17717 031425-29387 020625-18154 031425-27979 031425-28268 031425-28776 031425-28533 031425-30170 031425-30003 031425-29758 031425-30051 031425-29371 031425-30053 031425-30054 031425-28843 031425-28518 031425-29377 031425-29149 010625-15192 010625-13994 021725-21266 021725-20414 021725-22385 021725-21272 021725-22719 021725-21320 021725-22327 021725-22399 021725-20333 021725-22602 021725-20366 021725-20411 021725-21575 021725-22391 021725-20400 021725-20587 021725-22596 021725-22336 021725-22635 021725-21516 021725-22665 021725-21318 021725-20395 021725-21519 021725-22677 021725-20643 021725-20636 021725-21631 021725-22402 021725-22606 021725-20…

Products covered by this recall

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

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Serial number

On the rating plate, often next to the date of manufacture.

  • s. 021725-20339 021725-22682 120924-06125

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

GE Healthcare Finland Oy — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: GE Healthcare Finland Oy — Kuortaneenkatu 2, Helsinki

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was GE Healthcare Finland Oy medical devices recalled?

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. 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…

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Device enforcement record, and contact the company if you are unsure.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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