Z-0284-2027

ETHILON Nylon Suture, Product Code 697G

Name: Z-0284-2027 ETHILON Nylon Suture, Product Code 697G
Creator: Ethicon, LLC
Published: 2026-09-23
License: https://open.fda.gov/license/

Ethicon, LLC / initiated 2026-09-23 / Open, Classified

FDA source

Recall record

Recall number: Z-0284-2027
Status: Open, Classified
Initiated: 2026-09-23
Posted: 2026-10-23
Recalling firm: Ethicon, LLC
Product: ETHILON Nylon Suture, Product Code 697G
Product code: GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
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.
FDA root cause: Process control
Action: On 9/3/2026, field safety notices were mailed to customers who were asked to do the following: 1) Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Return affected product to firm. 3. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return and forward them this recall notice. 4. Complete and return the Business Reply Form (BRF) via email to [email protected]
Quantity in commerce: 4,003
Distribution: International distribution to the countries of JP, CA, AU.
Product codes and lots: GTIN Box/Unit: 30705031008568/10705031008564. Lot: 10B3QS

Product code GAQ

K946173Class IIStainless Steel, Gut, Poly (Glycolide/l-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and SilkETHICON, Inc. / cleared 1995-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-28, the FDA export date for this dataset. Page last changed 2026-10-30. View this recall on fda.gov (opens on fda.gov)