Teleflex Medical — Class II medical device recall Z-1557-2014
Terminated recall by Teleflex Medical, reported 2014-05-14, distributed in AL, CA, FL, GA, IL, IN, KS, LA…. Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached fr
| Recall number | Z-1557-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Durham, NC, United States |
| Recall initiated | 2014-03-11 |
| Classified | 2014-05-06 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2017-08-14 |
| Distributed | AL, CA, FL, GA, IL, IN, KS, LA, MA, ME, MI, MN, MO, MS, NJ, NM, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI, WV |
| Countries outside the US | CA, DE, IE |
| Quantity | 32,271 units |
| Reason classes | potency, device malfunction |
| Lot numbers | 02A0902278, 02A0902858, 02A1103450, 02A1200503, 02A1201015, 02B0900089, 02B0901762, 02B0902976, 02B1002276, 02B1002310, 02B1101450, 02C0900661, 02C0903400, 02C1002207, 02C1002218, 02C1002252, 02C1103707, 02C1103731, 02D0900010, 02D0900103, 02D0900634, 02D0900775, 02D0902457, 02D1003285, 02D1003286, 02D1100186, 02E0901921, 02E0902608, 02E1002342, 02E1301581, 02F0902457, 02F1100069, 02F1100124, 02F1101036, 02F1301100, 02F1302321, 02F1302322, 02G1000045, 02G1002594, 02G1003092 and 29 more |
Product
Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, Blue Monofilament Polypropylene Suture, Nonabsorbable Surgical Suture USP, Deknatel; Deklene MAXX, Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP, Deknatel. Indicated for use in soft tissue approximation.
Reason for recall
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
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-1557-2014. 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.