Terumo Recalls Winged Infusion Sets Due to Improper Bonding
Terumo Medical Corp is recalling 80,500 units of Surflo Winged Infusion Sets distributed in California due to potential improper bonding between the tube and luer.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (improper bonding) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Medical Corp is recalling 80,500 units of the Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code SV-S25FL35. The affected lots are 1508023, 1509011, and 1510004. These products were distributed in California.
The recall is being conducted because of potential improper bonding between the tube and the luer. This defect could compromise the integrity of the infusion set during use.
Healthcare providers and facilities that have received these specific lots should stop using them and contact Terumo Medical Corp for instructions on return or replacement. Consumers should not use these products if they have them in their possession.
The recalled product
- Product
- Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
- Manufacturer
- Terumo Medical Corp
- Category
- Medical Device — Infusion Sets
- Affected units
- 80,500
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)
- Product Code: SV-S25FL35 Lot Numbers 1508023
- 1509011 and 1510004.
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Terumo Medical Corp
See all →- HighTerumo Recalls Angio-Seal Evolution Vascular Closure Devices
FDA (Devices) · 2018-07-11
- ModerateTerumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect
FDA (Devices) · 2017-12-20
- ModerateTerumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect
FDA (Devices) · 2017-12-20
- HighTerumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal
FDA (Devices) · 2017-12-20
- ModerateTerumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect
FDA (Devices) · 2017-12-20
Same hazard · structural defect
See all →- SevereVolvo Recalls EX30 and EX30CC Vehicles for Head Restraint Defect
NHTSA · 2026-10-09
- Severe
- Severe
- SevereONTHEWEI Recalls Baby Bath Seats Due to Drowning Risk
CPSC · 2026-10-08
- SevereDecathlon Recalls Van Rysel GRVL AF Bicycles Due to Crash Hazard
CPSC · 2026-10-08
Similar recalls
- ModerateTerumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity
FDA (Devices) · 2019-07-31
- HighTerumo Cardioplegia Delivery Set Line Recalled for Luer Connector Defect
FDA (Devices) · 2014-11-12
- HighTerumo Custom Cardioplegia Delivery Sets Recalled for Luer Connector Seal Defect
FDA (Devices) · 2014-11-12
- ModerateTerumo Sur-vet Needle Recall Due to Potential Sterility Compromise
FDA (Devices) · 2019-07-31
- HighTerumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect
FDA (Devices) · 2014-11-12
- HighTerumo Medical Recalls 23G Needles Due to Potential Sterility Compromise
FDA (Devices) · 2019-07-31