CLASS II ONGOING Device recall · Reported 13 Nov 2024 · FDA Enforcement Report
Coated Vicryl Polyglactin 910 Suture VIO USP0(M3.5) S/A CT recalled
Ethicon is recalling Coated Vicryl Polyglactin 910 Suture VIO USP0(M3.5) S/A CT, Product Number J358H. The recall was initiated on 25 Sep 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0319-2025
- FDA event ID
- 95516
- Recalling firm
- Ethicon, Raritan, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Sep 2024
- FDA classified
- 7 Nov 2024
- Reported
- 13 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Surgical Instruments
Timeline
| 25 Sep 2024 | Recall initiated by company | |
| 7 Nov 2024 | Classified by FDA | +43 days |
| 13 Nov 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Where it was distributed
International distribution to the country of China.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 10705031237308 (each); 30705031237302 (box); Lot Number: QP2AJM
Where was it sold?
International distribution to the country of China.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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