Gore DrySeal Flex Introducer Sheath — Class II medical device recall Z-1962-2020
Terminated recall by W. L. Gore & Associates Inc., reported 2020-05-20. The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr de
| Recall number | Z-1962-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | W. L. Gore & Associates Inc., Phoenix, AZ, United States |
| Recall initiated | 2019-11-18 |
| Classified | 2020-05-11 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2020-05-13 |
| Countries outside the US | AT, BE, CH, CZ, DE, DK, ES, FI, FR, GB, GR, IE, IT, JP, NO, SE |
| Quantity | 141 devices |
| Reason classes | labeling |
| Serial numbers | 21060886, 21060888, 21061622, 21061623, 21061624, 21061625, 21061626, 21061627, 21077177, 21077178, 21077179, 21077180, 21077181, 21077183, 21077184, 21077185, 21077186, 21077187, 21077188, 21077189, 21077190, 21077191, 21077192, 21077193, 21077194 and 116 more |
| Model numbers | 14FR, 33CM, DSF1433 |
Product
Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
Reason for recall
The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1962-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.