Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2641-2018·Announced 2018-08-15

ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

ICU Medical is recalling specific blood tubing sets labeled as DEHP-free that may contain small amounts of the chemical.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a labeling error regarding the presence of DEHP, which aligns with the rubric for minor labeling errors or low-risk contamination.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 88-inch 20 Drop Y-Type Blood Sets with 200 Micron Filters, Hand Pumps, and Clave Connectors. The affected devices are single-use, sterile, non-pyrogenic accessories intended for needle-free withdrawal of blood as an adjunct to blood tubing sets or venipuncture devices.

The recall was initiated because some of these devices were labeled as "Does not contain DEHP" even though the product may contain small amounts of DEHP. The affected items are identified by Item Number Z1646 and Lot Numbers 69-335-SJ, 71-178-Y1, 73-160-HE, and 74-716-JW.

The products were distributed nationwide in the United States to 29 states and internationally to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Healthcare facilities and distributors should stop using the affected devices and contact ICU Medical for further instructions.

The recalled product

Product: 88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Blood Administration
Hazard: mis-labeling
dehp-exposure
Affected units: 160,016

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 (5)

Item Number Z1646
Lot Number 69-335-SJ
71-178-Y1
73-160-HE
74-716-JW

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

Part of a larger recall action

This product is one of 53 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 53 products in this recall →

Same manufacturer · ICU Medical, Inc.

See all →

High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23

Same hazard · mis labeling