TVS LPA — Class II medical device recall Z-2564-2018
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-2564-2018 |
|---|---|
| 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 | 3,530 |
| Reason classes | microbial contamination, sterility |
| Lot numbers | 17338821, 18019045 |
| Model numbers | DIL-059-00 |
Product
TVS LPA, Catalog #: DIL-059-00
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-2564-2018. 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.