Sutures — Class II medical device recall Z-1296-2014
Terminated recall by Teleflex Medical, reported 2014-04-02, distributed nationwide. The products are being recalled because they did not meet minimum needle attachment strength requirements.
| Recall number | Z-1296-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2014-03-11 |
| Classified | 2014-03-25 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2017-08-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, IE |
| Quantity | 32,271 units |
| Reason classes | potency |
| Lot numbers | 02E0801603 |
Product
Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
Reason for recall
The products are being recalled because they did not meet minimum needle attachment strength requirements.
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-1296-2014. 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.