ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling
ICU Medical is recalling specific blood tubing sets because they 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, but the hazard is a minor labeling error regarding the presence of small amounts of DEHP, which fits the criteria for moderate severity involving low-risk issues or labeling errors.
Plain-English summary
ICU Medical, Inc. is recalling 160,016 units of 80-inch 20 Drop Y-Type Blood Sets with 200 Micron Filters, Hand Pumps, and CLAVE Connectors. The recall involves specific lot numbers including 69-333-SJ, 69-703-SJ, 70-417-SL, 70-939-SJ, 71-366-Y1, 71-898-Y1, and 72-280-HE.
The reason for the recall is a labeling error. Some of the devices were labeled as "Does not contain DEHP" even though the product may contain small amounts of DEHP. The devices are single-use, sterile, non-pyrogenic accessories intended for needle-free withdrawal of blood.
The affected products were distributed nationwide in the United States to 29 states, as well as 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 replacement.
The recalled product
- Product
- 80" (203 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.
- 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 (8)
- Item Number Z0878
- Lot Number 69-333-SJ
- 69-703-SJ
- 70-417-SL
- 70-939-SJ
- 71-366-Y1
- 71-898-Y1
- 72-280-HE
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 →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02