CUSTOM SUTURE PACK — Class II medical device recall Z-2547-2017
Terminated recall by Medtronic, reported 2017-06-21, distributed nationwide. Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture
| Recall number | Z-2547-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic, North Haven, CT, United States |
| Recall initiated | 2017-05-03 |
| Classified | 2017-06-14 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2019-07-18 |
| Distributed | Nationwide (US) |
| Quantity | 478,465 |
| Reason classes | specification failure, packaging |
| Model numbers | US1540, US1614 |
Product
CUSTOM SUTURE PACK; Item Number: US1540 and US1614
Reason for recall
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
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-2547-2017. 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.