Recall archive / FDA device enforcement
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H — FDA record Z-0319-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 25, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
- Reason
- Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
- Classification
- Class II
- Recalling firm
- Ethicon, Inc.
- Quantity
- 31,032 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0319-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 10705031237308 (each); 30705031237302 (box); Lot Number: QP2AJM |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the country of China.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 13, 2024
- Recall initiation date
- Sep 25, 2024
- Center classification date
- Nov 7, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.