CLASS I ONGOING Device recall · Reported 24 May 2023 · FDA Enforcement Report

ASM Replacement Battery, Component Number SUB0000594 recalled

ICU Medical is recalling ASM Replacement Battery, Component Number SUB0000594. The recall was initiated on 22 Mar 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot Numbers: 5660479

Quantity recalled344 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1568-2023
FDA event ID: 91874
Recalling firm: ICU Medical, Lake Forest, IL
Classification: Class I
Status: Ongoing
Recall initiated: 22 Mar 2023
FDA classified: 16 May 2023
Reported: 24 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

22 Mar 2023	Recall initiated by company
16 May 2023	Classified by FDA	+55 days
24 May 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

ASM Replacement Battery, Component Number SUB0000594

Where it was distributed

worldwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Numbers: 5660479

Where was it sold?

worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 91874

This product is part of a recall event; the main page for the event is Replacement Battery List Number SUB0000864, found recalled.

Reported	Class	Recall	Company	Reason	Where
24 May 2023	CLASS I	Replacement Battery List Number SUB0000864, found recalled	ICU Medical	Device Malfunction	IL
24 May 2023	CLASS I	ASM Replacement Battery, Component Number SUB0000864 recalled	ICU Medical	Device Malfunction	IL
24 May 2023	CLASS I	Replacement Battery List Number SUB0000594 found recalled by ICU Medical	ICU Medical	Device Malfunction	IL

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All 654

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29 Jul 2026Device	CLASS II	Hotline Fluid Warming Set, single use device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
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17 Jun 2026Device	CLASS II	Plum Solo Precision IV Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Infusion Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Precision IV Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide

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