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
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 risk-of-harm product (sterile medical device) where the sterile barrier is compromised, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Terumo Medical Corp is recalling specific lots of Glidesheath Slender Hydrophilic Coated Introducer Sheaths, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA. The recall is due to an incomplete seal at the chevron end of the primary packaging, which was detected in a small quantity of the affected lot population (0.01% or 1 in 10,000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
The affected products were distributed nationwide and in Canada. The recall covers specific lot numbers listed in the agency's structured data, including lots from 161020 through 170201. The product is sterile and prescription-only.
Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using these products. Consumers should not use these products if they have them in their possession.
The recalled product
- Product
- Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
- Manufacturer
- Terumo Medical Corp
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 (20)
- Lot s 161020
- 161021
- 161024
- 161025
- 161027
- 161028
- 161031
- 161101
- 161104
- 101107
- 101108
- 161109
- 161110
- 161111
- 161114
- 161121
- 161122
- 161123
- 161124
- 161125
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
- ModerateTerumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect
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