ICU Medical Recalls Blood Tubing Accessories Due to DEHP Labeling Error
ICU Medical is recalling 160,016 units of blood tubing accessories because some were labeled as not containing DEHP, despite potentially containing small amounts.
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, but the source text describes a labeling error regarding DEHP content without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 132" (335 cm) Y-Type Admin Sets with 170 Micron Blood Filters. The recall is due to a labeling error where some devices were marked as "Does not contain DEHP" even though the product may contain small amounts of DEHP.
The affected devices are single-use, sterile, non-pyrogenic blood tubing accessories intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood. The recall covers specific lot numbers including 70-208-SL, 71-173-Y1, 72-647-HE, 72-907-HE, 73-629-HE, 74-456-JW, 74-721-JW, 75-434-JW, 75-761-JW, and 75-959-JW.
The devices 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 lots and contact ICU Medical for instructions on return or disposal.
The recalled product
- Product
- 132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, 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
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Blood Tubing
- 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 (11)
- Item Number Z2451
- Lot Number 70-208-SL
- 71-173-Y1
- 72-647-HE
- 72-907-HE
- 73-629-HE
- 74-456-JW
- 74-721-JW
- 75-434-JW
- 75-761-JW
- 75-959-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