PERMA-HAND Silk Sutures Recalled for Packaging Sterility Breach
Ethicon is recalling PERMA-HAND Silk Sutures that may have open seals on packaging due to manufacturing defects, risking sterility compromise and patient infection. Approximately 78,792 units were distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II recall with a high-risk pathway to infection via sterility breach of surgical sutures. Although no illnesses or injuries have been reported, the hazard is serious and theoretical—compromised sterility in surgical instruments poses clear risk of harm. Per the rubric, with no reported illness and theoretical hazard, the maximum score is 3 (High).
Plain-English summary
Ethicon, LLC is recalling PERMA-HAND Silk Sutures due to potential open seals on the primary packaging caused by a manufacturing issue on a specific machine. The affected product models are REF K872H, W723H, 623H, and K833H, along with other related product codes listed by the FDA.
An open seal on the suture packaging could allow breach of sterility, potentially introducing pathogens to patients during surgery. This poses a risk of infection, particularly in surgical applications including cardiovascular, ophthalmic, and neurosurgical procedures where sterility is critical.
Approximately 78,792 units were affected and distributed worldwide, including across all U.S. states and multiple international countries. Healthcare facilities should immediately cease use of recalled batches and verify lot numbers against the published FDA recall list.
Patients who have received these sutures should contact their healthcare provider if they develop signs of infection at the surgical site. The FDA recommends health care providers and patients report any adverse events to the FDA's MedWatch program.
The recalled product
- 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.
- Manufacturer
- Ethicon, LLC
- Affected units
- 78,792
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI-GTIN/Lot(expiration): F2416H/10705031238947/103E7C(8/31/2029)
- EH7808B/10705031239425/103E7A(8/31/2029)
- 661H/10705031007703/103GR7(8/31/2029)
- 103H5A(8/31/2029)
- 1669H/10705031001879/103GR2(8/31/2029)
- 103J14(8/31/2029)
- 644H/10705031089594/103EXA(8/31/2029)
- EH7827B/10705031239074/103EX9(8/31/2029)
- F3223BH/10705031240940/103EJH(8/31/2029)
- EH7797BH/10705031239487/103J2H(8/31/2029)
- 628H/10705031007000/1033PK(7/31/2029)
- 699G/10705031008625/102TMJ(7/31/2029)
- K872H/10705031044586/103DBT(8/31/2029)
- W723H/10705031202450/103G13(8/31/2029)
- 623H/10705031006898/10386S(8/31/2029)
- K833H/10705031044388/103K99(8/31/2029)
- 6664H/10705031089808/103G1B(8/31/2029)
- X425H/10705031057296/103H4B(8/31/2029)
- X872H/10705031058187/103DBT(8/31/2029)
- EH7491H/10705031096806/103D42(8/31/2029)
Distribution
Part of a larger recall action
This product is one of 3 recalled by Ethicon, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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