Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2657-2018·Announced 2018-08-15

ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

ICU Medical is recalling 116-inch Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product 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, but the source text describes a labeling error regarding DEHP content without reporting any illnesses, injuries, or hospitalizations. Per the rubric, minor labeling errors or low-risk issues without reported harm fall under Moderate severity.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 116" (295 cm) Y-Type Blood Sets with 170 Micron Filter, Hand Pump, 3 MicroClave, 2 Ext, Rotating Luer, Sterile. The specific item number is Z4088 and the lot number is 3429743. These devices are single-use, sterile, non-pyrogenic blood tubing accessories intended for needle-free withdrawal of blood.

The recall was initiated because some devices were labeled as "Does not contain DEHP" even though the product may contain small amounts of DEHP. This is a labeling discrepancy regarding the presence of a chemical component in the medical device.

The affected products were distributed worldwide, including nationwide distribution in the United States to specific states and to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. Users of these devices should check their inventory for the specific item and lot numbers listed above. If found, they should stop using the devices and contact ICU Medical for further instructions.

The recalled product

Product: 116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, Rotating Luer, 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 (2)

Item Number Z4088
Lot Number 3429743

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