ICU Medical Recalls Sapphire Infusion Sets Due to Potential Fluid Leakage
ICU Medical is recalling Sapphire Epidural Infusion Sets because fluid may leak from the inline filter air vents. The recall covers 26,700 units distributed nationwide and internationally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in medical devices, are categorized as Severe (Score 4).
Plain-English summary
ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with Inline Filters, specifically the Sapphire Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. The recall involves 26,700 units. The product is identified by Product Code 163730455 and specific lot numbers including 896225H, 916845H, 925825H, and 948155H.
The recall is being conducted because of a potential for fluid leakage out of the air vents on the inline filters. This defect could compromise the integrity of the infusion set during use. The agency has classified this as a Class II recall.
The affected products were distributed nationwide to all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. International distribution included Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, and the United Arab Emirates. Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical for instructions on return or replacement.
The recalled product
- Product
- Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case
- Manufacturer
- ICU Medical Inc
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 26,700
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 (6)
- Product Code: 163730455
- Lot number (UDI Number): 896225H (20887787007408
- 10887787007401)
- 916845H (20887787007408
- 925825H (20887787007408
- 948155H (20887787007408
Distribution
Part of a larger recall action
This product is one of 22 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 22 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 · fluid leakage
See all →- HighHalyard STANDARD LINE INSERTION PACK Recall for Silicone Seal Defect
FDA (Devices) · 2026-07-29
- SevereAbiomed Impella Introducer Kit recalled for potential fluid leakage
FDA (Devices) · 2026-07-22
- SevereABIOMED Insertion Kit heart pump accessories introducer sheath leakage
FDA (Devices) · 2026-07-22
- SevereMedline Dialysis Kits Recalled Over Tego Connector Seal Defects
FDA (Devices) · 2026-03-04
- HighMedline Kits with Tego Connectors Recalled Due to Silicone Seal Defects
FDA (Devices) · 2026-03-04