The Recall Desk
HighFDA (Devices)·Z-0365-2026·Announced 2025-11-05

Chemotherapy vial adapters recalled because port weld may separate and leak

ICU Medical is recalling 202,900 ChemosafeLock Vial Adapters because the port weld of the drug transfer device may separate or break during use and leak.

What this means for you

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

ICU Medical ChemosafeLock Vial Adapters are being recalled across REFs KL-VA001U3, KL-VA002U3, KL-VA131U3, KL-VA201U3, KL-VA202U3 and KL-VA321U3.

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

The recall covers 202,900 units across lots including 14360690, 14345871, 14367719, 14381368, 14381367, 14345872 and 14381373. 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 adapters are used to transfer hazardous drugs, facilities should quarantine affected lots and follow ICU Medical's instructions.

The recalled product

Product
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Drug transfer device
Hazard
Affected units
202,900

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 (7)

  • Lot:KL-VA001U3: 14360690 14345871 14367719 14381368 14381367
  • KL-VA002U3: 14345872
  • KL-VA131U3: 14381373
  • KL-VA201U3: 14337455 14381355 14381358
  • KL-VA202U3: 14367718
  • KL-VA321U3: 14345878
  • Distributed in Japan

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 →

Related recalls

Same manufacturer · ICU Medical, Inc.

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Same hazard · weld failure

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