ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling
ICU Medical is recalling 160,016 blood sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.
What this means for you
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 due to a labeling error regarding DEHP content. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity category.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 162" Y-Type Blood Sets with 170 Micron Filters, Bulb Hand Pumps, and CLAVE Connectors. The recall is due to a labeling error where some devices were marked as "Does not contain DEHP" despite potentially containing small amounts of DEHP.
The affected devices are single-use, sterile, non-pyrogenic accessories intended for needle-free withdrawal of blood. The recall covers specific lot numbers including 70-577-SL, 70-753-SL, and others listed in the agency record. Distribution was worldwide, including nationwide distribution across 29 US states and sales to Canada, Cyprus, Japan, Kuwait, Malaysia, and South Africa.
Healthcare facilities and consumers should stop using the affected blood sets and contact ICU Medical for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- 162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Luers, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct
- Manufacturer
- ICU Medical, Inc.
- 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 (19)
- Item Number Z1278
- Lot Number 70-577-SL
- 70-753-SL
- 71-103-Y1
- 71-193-Y1
- 71-536-Y1
- 71-704-Y1
- 71-989-Y1
- 72-409-HE
- 72-538-HE
- 72-555-HE
- 72-928-HE
- 73-176-HE
- 73-393-HE
- 73-623-HE
- 73-871-HE
- 74-613-JW
- 74-713-JW
- 75-088-JW
Distribution
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 →Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22
- SevereICU Medical Plum Solo Precision IV Pump May Deliver Excess Medication
FDA (Devices) · 2026-07-22
- HighPlum Duo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Solo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02