ICU Medical, Inc. LifeShield Drug Library Management , LifeShield Infusion Safety recall: Software issue only allows Concentration Limits to be defined to one digit
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
The hazard: Device malfunction
This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.
What the notice says: Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.
Symptoms and when to call a doctor
If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.
This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.
Recall details
- Recall number
- Z-0966-2026
- Published
- December 31, 2025
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- ICU Medical, Inc.
- Product type
- Medical devices
- Units affected
- 12 customers
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
- UPC codes
- 00887709127227
Products covered by this recall
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
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.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 00887709127227
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 Malfunction
ICU Medical, Inc. — This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
- Report device problems to the FDA through MedWatch — that database is where this recall came from.
- If the device is implanted, or you depend on it daily, speak to your clinician before changing anything about how you use it.
- Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.
Replacements, repairs and reimbursement
Device remedies run through the supply chain, so the route depends on who sold you the unit.
- Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
- If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
- Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
- Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.
Company contact: ICU Medical, Inc. — 600 N Field Dr, Lake Forest, IL, 60045-4835
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 ICU Medical, Inc. medical devices recalled?
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery. Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change…
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 00887709127227. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
Can I get my money back?
Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
Where was the recalled product sold?
It was distributed nationwide.
Related recalls
-
Class II · last month
ICU Medical, Inc. Oncology sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
-
Class II · last month
ICU Medical, Inc. Oncology sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
-
Class II · last month
ICU Medical, Inc. IV Sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
-
Class II · last month
ICU Medical, Inc. Plum administration sets recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
-
Class II · last month
ICU Medical, Inc. IV Sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
-
Class II · last month
ICU Medical, Inc. IV Non-Dedicated Gravity Administration Sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…