Coated VICRYL RAPIDETM — Class II medical device recall Z-0693-2018
Terminated recall by Ethicon, Inc., reported 2018-03-07. On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25)
| Recall number | Z-0693-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2017-08-17 |
| Classified | 2018-02-23 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2019-05-08 |
| Quantity | 129,372 eaches |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 10705031080256, 10705031080294, 10705031086524, 10705031086548, 10705031099968, 10705031106048, 10705031111127, 10705031111172, 10705031111264, 10705031111332, 10705031119925, 10705031119956, 10705031119970, 10705031130845, 10705031130937, 10705031130999, 10705031133358, 10705031134669, 10705031134683, 10705031134690, 10705031134744, 10705031134768, 10705031149168, 10705031151970, 10705031152007 |
Product
Coated VICRYL RAPIDETM (Polyglactin 910) Suture
Reason for recall
On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. During finished goods testing, a suture damage was identified on a lot of VICRYL RAPIDETM Suture. During the course of the subsequent investigation, the suture also failed knot tensile strength testing.
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-0693-2018. 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.