ICU Medical Inc. Smiths Medical CADD" Medication Cassette Reservoir with flow stop recall: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
The hazard: Device safety concern
This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.
What the notice says: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
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-2525-2025
- Published
- September 10, 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
- 211750 units
- Made in
- United States
- Lot / code info
- UDI/DI 10610586027215, Lot Numbers: 6005583, 6005584, 6005588, 6012462, 6022021, 6022022, 6022023, 6022024, 6022025, 6022026, 6022028, 6022030, 6022031, 6022032, 6026837, 6026839, 6037765, 6037768, 6037771, 6059294, 6059295, 6059296, 6062697, 6062698, 6077779, 6085509, 6092859, 6101810
- UPC codes
- 10610586027215
Products covered by this recall
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
Check your product
The notice names 12 codes 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.
- 10610586027215
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 6005583
- 6005584
- 6005588
- 6012462
- 6022021
- 6022022
- 6022023
- 6022024
Model or item number
On the rating label, the box or the instruction sheet.
- 21-7301-24 — UDI
- DI 10610586027215
Package size
Match the net weight or the piece count on the front of the pack.
- 50 mL
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
ICU Medical Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
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. — 6000 Nathan Ln N, Minneapolis, MN, 55442-1690
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?
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter. Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 10610586027215; lot code 6005583, 6005584, 6005588; model number 21-7301-24 — UDI, DI 10610586027215. 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 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.
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