Sengstaken Tube and Sengstaken-Blakemore Tube — Class II medical device recall Z-1506-2014
Terminated recall by Teleflex Medical, reported 2014-04-30, distributed nationwide. Sterility of the product cannot be guaranteed.
| Recall number | Z-1506-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Durham, NC, United States |
| Recall initiated | 2014-03-04 |
| Classified | 2014-04-24 |
| Reported by FDA | 2014-04-30 |
| Terminated | 2016-01-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BM, BR, BS, CA, CL, CN, CR, CW, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, GT, GY, HU, IL, IN, IT, JO, JP, KW, LU, LV, MT, MX, NG, NI, NL, NO, OM, PE, PL, PT, SG, TH, TN, TR, UY |
| Quantity | 117,801 units |
| Reason classes | sterility |
| Lot numbers | 10201, 10251, 10301, 10381, 10401, 10481, 11041, 11201, 11321, 12151, 12231, 1226, 12311, 123821, 12474, 13151, 13191, 13211, 13261, 13381 |
Product
Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract.
Reason for recall
Sterility of the product cannot be guaranteed.
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-1506-2014. 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.