CLASS II ONGOING Device recall · Reported 4 Nov 2026 · FDA Enforcement Report

Ethilon Nylon Suture recalled by Ethicon

Ethicon is recalling Ethilon Nylon Suture, distributed in California. The recall was initiated on 23 Sep 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN Box/Unit: 30705031008568/10705031008564. Lot: 10B3QS

Quantity recalled4,003

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0284-2027
FDA event ID: 99947
Recalling firm: Ethicon, San Lorenzo, PR
Classification: Class II
Status: Ongoing
Recall initiated: 23 Sep 2026
FDA classified: 23 Oct 2026
Reported: 4 Nov 2026
Type: Voluntary: Firm initiated
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

23 Sep 2026	Recall initiated by company
23 Oct 2026	Classified by FDA	+30 days
4 Nov 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including tearing or bleeding intraoperatively.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

ETHILON Nylon Suture, Product Code 697G

Where it was distributed

International distribution to the countries of JP, CA, AU.

California

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN Box/Unit: 30705031008568/10705031008564. Lot: 10B3QS

Where was it sold?

International distribution to the countries of JP, CA, AU.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 10 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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