Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2630-2018·Announced 2018-08-15

ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

ICU Medical is recalling 160,016 units of 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 and involves a minor labeling error regarding DEHP content, with no reported illnesses or injuries in the source text.

Plain-English summary

ICU Medical, Inc. is recalling 160,016 units of 175" (445 cm) Y-Type Blood Sets with 170 Micron Blood Filter, Hand Pump, Inj Site, Remv 3 Gang 4-Way Stopcocks w/Baseplate, 2 Clave, Rotating Luer, 1 Ext, Sterile. The recall is due to a labeling error where some devices were marked as "Does not contain DEHP" despite the possibility that the product contains small amounts of DEHP.

The affected devices are identified by Item Number B9757 and Lot Number 3371153. These single-use, sterile, non-pyrogenic devices are intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

The products were distributed nationwide in the United States to 29 states and internationally to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these devices.

The recalled product

Product: 175" (445 cm) Y-Type Blood Set w/170 Micron Blood Filter, Hand Pump, Inj Site, Remv 3 Gang 4-Way Stopcocks w/Baseplate, 2 Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Blood Administration Sets
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 B9757
Lot Number 3371153

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