---
title: "Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Produc... — FDA record Z-0319-2025 | Is It on Recall"
description: "Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually"
url: https://isitonrecall.com/recall/fda-device-z-0319-2025-coated-vicryl-polyglactin-910-suture-vio-36in-90cm-usp0-m3-5-s-a-ct-product-number-j358h/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0319-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0319-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Ethicon, Inc. records](https://isitonrecall.com/brand/ethicon-inc/)