Ethicon PERMA-HAND Silk Suture Recalled Over Alcohol Contamination 2026

Health Canada has classified a recall of Ethicon LLC’s PERMA-HAND™ Silk Suture as a Type II action, flagging a manufacturing error that left an unapproved alcohol-based fluid inside the sterile packaging of a single lot distributed to healthcare facilities.

The affected lot, identified as RLBDPJ under model or catalogue number N271H, was found to contain a tubing fluid that should never have been part of this product’s manufacturing process. According to Health Canada, the fluid is a solution of isopropyl alcohol (IPA), diethylaminoethanol (DEAE), and sodium benzoate that had previously been used to manufacture a different suture product entirely.

What Products Are Being Recalled?

The recall applies specifically to PERMA-HAND™ Silk Suture bearing lot number RLBDPJ and model or catalogue number N271H. No other lots or suture products from Ethicon are named in the Health Canada notice. The product falls under the category of health products used in general and plastic surgery.

Why Was This Recall Issued?

Ethicon determined during its own review that the recalled suture was incorrectly manufactured with an alcohol-based tubing fluid inside the primary packaging. Health Canada’s notice states that up to 80% of the impacted lot may have had the alcohol-based tubing fluid present. This substance is not a material approved for use anywhere in the manufacturing of PERMA-HAND™ Silk Suture, meaning its presence represents a clear deviation from the product’s intended composition and sterile packaging standards.

Because sutures are implanted directly into surgical sites, any unapproved chemical residue in the packaging raises questions about tissue compatibility and wound healing, which is likely why regulators moved to flag the issue as a formal recall rather than a routine quality notice.

Who Is Affected?

The recall is aimed at the healthcare sector rather than the general public. Hospitals, surgical centers, and clinics that purchased PERMA-HAND™ Silk Suture from Ethicon LLC, whose manufacturing address is listed as Highway 183 Km 8.3, San Lorenzo, Puerto Rico, should check their surgical supply inventories against the affected lot number.

• Product: PERMA-HAND™ Silk Suture
• Lot number: RLBDPJ
• Model/catalogue number: N271H
• Recall class: Type II
• Recall date: September 11, 2026
• Identification number: RA-82681

What Should You Do?

Healthcare facilities and clinical staff who hold surgical supplies bearing lot RLBDPJ should isolate the affected suture and refrain from using it in patients. Health Canada’s guidance is straightforward: contact the manufacturer directly if additional information is required about the scope of the issue or next steps for returning or replacing affected stock.

Given that this recall is directed at healthcare audiences rather than individual consumers, patients who have already undergone a procedure involving this product are encouraged to speak with their healthcare provider if they have concerns, though no specific patient-level adverse events have been detailed in the published notice.

Official Statement

Health Canada’s published notice states that Ethicon determined the recalled suture ‘was incorrectly manufactured with an alcohol-based tubing fluid in the primary packaging,’ and confirms that this tubing fluid material is ‘not a material approved for use in the manufacture of PERMA-HAND™ Silk Suture.’ The recall was originally published on September 25, 2026, and is listed under identification number RA-82681, with Ethicon LLC named as the responsible company and Health Canada as the publishing authority.

This recall is currently limited to the one identified lot, and Health Canada has not indicated that any other PERMA-HAND™ Silk Suture products are implicated.