Twisted Needle Defect Prompts Ethicon ETHILON Nylon Suture Recall 2026

Health Canada has published a Type II health product recall for a lot of Ethicon Nylon Suture after the manufacturer found that some units have needles that are distorted or twisted inside the primary packaging. The recall carries identification number RA-82713 and was dated September 23, 2026. Health Canada posted the notice on October 1, 2026.

The notice is aimed at healthcare audiences rather than the general public, since the product is a surgical device used in general and plastic surgery.

Regulatory Response

Health Canada classified the action as a Type II recall and describes it as a recall (removal). The issue is categorized as a medical device performance problem. The notice lists Ethicon LLC, based in San Lorenzo, Puerto Rico, as the company involved.

The notice is filed under Health products, Medical devices, General and plastic surgery. It was published by Health Canada and marked for a Healthcare audience.

Products Affected by This Recall

The recall covers a single lot of Ethicon Nylon Suture. The product is identified in the notice as ETHILON Nylon Suture. Key identifiers are below.

• Product: Ethicon Nylon Suture (ETHILON Nylon Suture)
• Lot number: 10B3QS
• Model or catalogue number: 697G
• Recall class: Type II
• Recall date: 2026-09-23
• Identification number: RA-82713

Anyone checking inventory should match both the lot number and the model number shown above. The notice does not list any other lots or models.

What Went Wrong?

According to Health Canada, Ethicon determined that some sutures from the recalled lot have needles that are distorted or twisted in the primary packaging. The notice says up to 17% of the impacted lot may have the needle defect.

That means most units in the lot may be unaffected, but the defect cannot be ruled out for any single package without inspection. The notice does not say how the problem was discovered, and it does not describe any injuries or adverse events linked to the defect.

Because the issue is listed as a performance problem, the concern centres on whether the needle works as intended during use. A twisted or distorted needle can be a problem for a device that surgeons rely on to be consistent.

Who Should Be Concerned

The recall is directed at the healthcare audience. Hospitals, surgical departments, clinics and supply managers that stock ETHILON Nylon Suture are the groups most likely to hold the affected lot. The notice does not say where in Canada the product was distributed, how many units are in the lot, or which facilities received it.

Patients are not asked to take any action in the notice. Anyone who has questions about a past or upcoming procedure should raise them with their surgeon or care team.

What Consumers Need to Do Now

The only action listed by Health Canada is for people to contact the manufacturer if they need additional information. The notice does not provide a phone number, email address or return process.

Healthcare facilities and suppliers can reasonably take these practical steps:

• Check stock for ETHILON Nylon Suture under model 697G.
• Compare any packages on hand against lot number 10B3QS.
• Contact Ethicon for further information, as the notice advises.
• Use the Health Canada recall page as the reference when documenting the check.

The notice does not state whether affected units should be returned, replaced or destroyed. Those details would need to come from the manufacturer.

Official Statement

Health Canada states that Ethicon determined some ETHILON Nylon Suture from the lot subject to this recall have needles that are distorted or twisted in the primary packaging, and that up to 17% of the impacted lot may have the needle defect. The agency’s guidance is to contact the manufacturer for additional information.

Health Canada also invites the public to report a health or safety concern through its reporting page, and offers email notifications for new and updated recalls and safety alerts through the recalls and safety alerts site.

Quick Takeaways

• Single lot affected: 10B3QS, model 697G.
• Up to 17% of the lot may have twisted or distorted needles.
• Type II recall, dated September 23, 2026, posted October 1, 2026.
• Healthcare audience; contact Ethicon for more information.

As with any medical device recall, facilities should rely on the official Health Canada notice and the manufacturer for the latest instructions, since details may be updated after publication.