---
title: "ASM Replacement Battery, Component Number SUB0000594 — FDA record Z-1568-2023 | Is It on Recall"
description: "Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and"
url: https://isitonrecall.com/recall/fda-device-z-1568-2023-asm-replacement-battery-component-number-sub0000594/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# ASM Replacement Battery, Component Number SUB0000594 — FDA record Z-1568-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 22, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: ASM Replacement Battery, Component Number SUB0000594
- **Reason**: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
- **Classification**: Class I
- **Recalling firm**: ICU Medical Inc
- **Quantity**: 344 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1568-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1568-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot Numbers: 5660479 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

worldwide

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: May 24, 2023
- **Recall initiation date**: Mar 22, 2023
- **Center classification date**: May 16, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1568-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [ICU Medical, Inc. records](https://isitonrecall.com/brand/icu-medical-inc/)