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.
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 2/5 (Moderate).
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 source text does not report any hospitalizations or injuries. The hazard is a potential sterility breach affecting a very small fraction of units (0.01%), which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported harm.
Plain-English summary
Terumo Medical Corp is recalling a specific lot of Glidesheath Slender Hydrophilic Coated Introducer Sheaths, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA. The recall affects units from Lot 161111 that were distributed nationwide and in Canada.
The recall was initiated because an incomplete seal was detected at the chevron end of the primary packaging. This defect affects a small quantity of the lot population, estimated at 0.01% (1 in 10,000 units). The breach of the sterile barrier may compromise the sterility of the sheath.
Healthcare providers and facilities should check their inventory for the affected lot number and stop using these devices if found. Consumers should not use these products and should contact their healthcare provider for guidance.
The recalled product
- Product
- Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, 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 161111
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
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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
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FDA (Devices) · 2026-09-30
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