Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal
Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.
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 defect affects only 0.01% of units and no injuries or illnesses are reported, fitting the criteria for a moderate risk of harm.
Plain-English summary
Terumo Medical Corp is recalling a specific lot of Glidesheath Slender Hydrophilic Coated Introducer Sheaths, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA. The recall affects Lot 170113, which was distributed nationwide and in Canada.
The recall was initiated because an incomplete seal at the chevron end of the primary packaging was detected in a small quantity of the affected lot population, representing 0.01% (1 in 10,000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Healthcare providers and facilities should check their inventory for this specific product code and lot number. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
- Manufacturer
- Terumo Medical Corp
- Hazard
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 (1)
- Lot 170113
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Terumo Medical Corp 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 17 products in this recall →Related recalls
Same manufacturer · Terumo Medical Corp
See all →- HighTerumo Recalls Angio-Seal Evolution Vascular Closure Devices
FDA (Devices) · 2018-07-11
- 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
- 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
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12