PERMA-HAND Silk Suture — Class II medical device recall Z-1097-2025

Ongoing recall by Ethicon, LLC, reported 2025-02-12, distributed nationwide. Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, an

Recall number	`Z-1097-2025`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Ethicon, LLC, San Lorenzo, PR, United States
Recall initiated	2024-12-20
Classified	2025-02-04
Reported by FDA	2025-02-12
Distributed	Nationwide (US)
Quantity	78,792
Reason classes	microbial contamination, sterility, packaging
UPC / GTIN / UDI-DI	`10705031001879`, `10705031006898`, `10705031007000`, `10705031007703`, `10705031008625`, `10705031044388`, `10705031044586`, `10705031057296`, `10705031058187`, `10705031089594`, `10705031089808`, `10705031096806`, `10705031202450`, `10705031238947`, `10705031239074`, `10705031239425`, `10705031239487`, `10705031240940`
Model numbers	`623H`, `K833H`, `K872H`, `W723H`

Product

PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.

Reason for recall

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

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-1097-2025. 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.