Tearaway Introducers — Class II medical device recall Z-2565-2018
Terminated recall by Galt Medical Corporation, reported 2018-08-08, distributed in CA, FL, GA, IL, KY, LA, MA, MN…. The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during
| Recall number | Z-2565-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Galt Medical Corporation, Garland, TX, United States |
| Recall initiated | 2018-05-02 |
| Classified | 2018-07-27 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2020-07-20 |
| Distributed | CA, FL, GA, IL, KY, LA, MA, MN, MO, MS, NC, NY, OH, PA, PR, TX, UT, VA, WA |
| Countries outside the US | AU, BE, CA, CH, DE, FR, GB, IE, IT, KR, NL, PL, SK |
| Quantity | 23,777 |
| Reason classes | microbial contamination, sterility |
Product
Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46
Reason for recall
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
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-2565-2018. 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.