Agency classClass IIOur severity:High FDA (Devices)·Z-0337-2026·Announced 2025-11-05

Oncology transfer kits recalled over port weld separation risk

ICU Medical is recalling 600 Oncology Transfer Kits with ChemoClave and ChemoLock ports because the port weld of the drug transfer device may separate or break during use and leak.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: a weld that can break and leak on a drug transfer device is a hazard, and no injuries are reported.

Plain-English summary

The ICU Medical Oncology Transfer Kit with ChemoClave and ChemoLock Port, Spiros with red cap and ChemoLock Port, REF CL4138, is being recalled.

The port weld of the drug transfer device may separate or break during use and potentially result in a leak.

The recall covers 600 units carrying UDI 10887709096131, from lot 14393176. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.

The enforcement record describes the weld failure and reports no injuries. Because these kits are used to transfer hazardous drugs, facilities should quarantine the affected lot and follow ICU Medical's instructions.

The recalled product

Product: ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Drug transfer device
Hazard: weld-failure
leak
drug-transfer
chemotherapy
Affected units: 600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

UDI:10887709096131/Lot: 14393176

Distribution

Distributed nationwide across the United States.

The notice also names 38 states specifically:

Part of a larger recall action

This product is one of 38 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 38 products in this recall →

Same manufacturer · ICU Medical, Inc.

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Same hazard · weld failure