W. L. Gore DrySeal Flex Introducer Sheath Mislabeling Risk
W. L. Gore recalls sterile 14Fr DrySeal Flex Introducer Sheaths mislabeled as 14Fr when they are 16Fr. Check serial numbers for affected units.
Lower-risk recall
The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
Contact the company
What happened, in plain English
W. L. Gore is recalling sterile 14Fr DrySeal Flex Introducer Sheaths that were mislabeled as 14Fr when they are actually 16Fr. This mislabeling could lead to incorrect use in medical procedures. Read more at govinfonow.com/recall/66512-w-l-gore-dryseal-flex-introducer-sheath-mislabeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/66512-w-l-gore-dryseal-flex-introducer-sheath-mislabeling-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1962-2020
Cite this page
“W. L. Gore DrySeal Flex Introducer Sheath Mislabeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66512-w-l-gore-dryseal-flex-introducer-sheath-mislabeling-risk. Based on FDA recall #Z-1962-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1962-2020%22&limit=1).
Why it’s dangerous
The sheaths were labeled as 14Fr (smaller diameter) but are actually 16Fr (larger diameter). Using the wrong size could cause improper insertion or complications during medical procedures.
Who’s affected
Healthcare professionals using these sheaths for medical procedures are most at risk. Patients receiving procedures with mislabeled sheaths could face complications.
How to tell if you have this one
Check for the product name 'Gore DrySeal Flex Introducer Sheath', catalog number DSF1433, and serial numbers listed in the recall notice. The sheaths are sterile and 33cm long.
- Brand
W. L. Gore- Category
Medical device
What to do — step by step
Check Serial Numbers
Compare your sheath's serial number against the list of affected serial numbers provided in the recall notice.
How this recall unfolded
Recall timeline
FDA terminated this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- FDA terminated the recall
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1962-2020 (November 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1962-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.