FDA Device recall Z-0068-2017
BioSentry Tract Sealant System, Product Code: 768022019S
- FDA Device
- Class II
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class II recall of BioSentry Tract Sealant System, Product Code: 768022019S by Surgical Specialties Mexico, citing surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0068-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-24 |
| Published | 2016-10-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Surgical Specialties Mexico |
| Distribution | AZ, CA, CO, CT, DE, FL, GA, ID, MA, NH, NJ, NV, NY, OH, OK, PA, TX, VA, VT, WA |
Product
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
Reason
Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.
Identifiers
| code_info | MAWX380, MAZD460, MAZR350, MBCF540 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0068-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.