Tenaxis Medical ArterX — Class II medical device recall Z-2687-2017
Terminated recall by Mallinckrodt Manufacturing LLC, reported 2017-07-12. Product was improperly labeled leading to improper storage.
| Recall number | Z-2687-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mallinckrodt Manufacturing LLC, Mountain View, CA, United States |
| Recall initiated | 2014-10-17 |
| Classified | 2017-07-06 |
| Reported by FDA | 2017-07-12 |
| Terminated | 2017-07-15 |
| Countries outside the US | GB |
| Quantity | 246 units |
| Reason classes | labeling |
| Lot numbers | 20928001, 211300001, 30308001, 30329001, 3092001, 31113001, 40108002, 40129001, 40226001, 40430001, 40611001 |
| Model numbers | 9002, 9006 |
Product
Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery.
Reason for recall
Product was improperly labeled leading to improper storage.
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-2687-2017. 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.