BioSentry Tract Sealant System — Class II medical device recall Z-0068-2017
Terminated recall by Surgical Specialties Mexico S DE RL DE CV, reported 2016-10-19, distributed in AZ, CA, CO, CT, DE, FL, GA, ID…. Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open s
| Recall number | Z-0068-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Surgical Specialties Mexico S DE RL DE CV, Tijuana, N/A, Mexico |
| Recall initiated | 2016-09-24 |
| Classified | 2016-10-11 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2016-12-06 |
| Distributed | AZ, CA, CO, CT, DE, FL, GA, ID, MA, NH, NJ, NV, NY, OH, OK, PA, TX, VA, VT, WA |
| Countries outside the US | DE, DK, ES, GB, IT, PT, TR |
| Reason classes | packaging |
Product
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
Reason for recall
Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.
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-0068-2017. 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.