Z-0284-2027 Class II Ongoing
FDA device recall Z-0284-2027 was initiated by Ethicon, LLC on Sep 23, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 4,003.
Recall details
- Product Type
- Devices
- Report Date
- Nov 4, 2026
- Initiation Date
- Sep 23, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,003
Product description
ETHILON Nylon Suture, Product Code 697G
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.
Distribution pattern
International distribution to the countries of JP, CA, AU.
Code information
GTIN Box/Unit: 30705031008568/10705031008564. Lot: 10B3QS
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0284-2027
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026