Recall Z-0284-2027 ยท GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Ethicon, LLC
ETHILON Nylon Suture, Product Code 697G
| Date | Oct 23, 2026 (initiated Sep 23, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| 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 be |
| Quantity | 4,003 |
| Distribution | International distribution to the countries of JP, CA, AU. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK ETHICON, Inc., Jan 9, 1995 |