CLASS II ONGOING Device recall · Reported 26 Jun 2024 · FDA Enforcement Report

PDS II (polydioxanone) Suture - Intended for use recalled by Ethicon

Ethicon is recalling PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, distributed nationwide in the US. The recall was initiated on 10 May 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 10705031026216 10705031060166 10705031060289 10705031060395 10705031060517 PRODUCT CODE PRODUCT LOTS VCP196H UBMDDB VCP417H UAMQML VCP602H UAMQQL UAMSCA VCP603H UAMHTC UAMHZZ UAMEDC VCP662H UBMJSH VCPB259H UAMPKR VCPB946H UAMLJA

Quantity recalled56952 units

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-2146-2024
FDA event ID: 94643
Recalling firm: Ethicon, Raritan, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 10 May 2024
FDA classified: 14 Jun 2024
Reported: 26 Jun 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

10 May 2024	Recall initiated by company
14 Jun 2024	Classified by FDA	+35 days
26 Jun 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H

Where it was distributed

Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.

Nationwide Arkansas California Colorado Illinois Pennsylvania Puerto Rico

Questions about this recall

Is PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation recalled?

Yes. Ethicon recalled PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation on 10 May 2024. The recall is Class II and its status is Ongoing. Recall number Z-2146-2024.

Why was it recalled?

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Which lots are affected?

GTIN 10705031026216 10705031060166 10705031060289 10705031060395 10705031060517 PRODUCT CODE PRODUCT LOTS VCP196H UBMDDB VCP417H UAMQML VCP602H UAMQQL UAMSCA VCP603H UAMHTC UAMHZZ UAMEDC VCP662H UBMJSH VCPB259H UAMPKR VCPB946H UAMLJA

Where was it sold?

Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.

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 21 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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1 Oct 2025Device	CLASS II	Stratafix Spiral PDS Plus Bidirectional Knotless Tissue recalled	Ethicon	Other	Nationwide
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12 Feb 2025Device	CLASS II	Ethibond Excel Polyester Suture recalled by Ethicon	Ethicon	Lead & Heavy Metals	Nationwide
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