CLASS II ONGOING Device recall · Reported 17 May 2023 · FDA Enforcement Report
Pds¿ Plus Antibacterial (polydioxanone) Suture recalled by Ethicon
Ethicon is recalling Pds¿ Plus Antibacterial (polydioxanone) Suture - Pds Plus Clr USP3-0(M2) S/A Pc-25 Prime, distributed nationwide in the US. The recall was initiated on 31 Mar 2023 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-1571-2023
- FDA event ID
- 92084
- Recalling firm
- Ethicon, Raritan, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Mar 2023
- FDA classified
- 10 May 2023
- Reported
- 17 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 31 Mar 2023 | Recall initiated by company | |
| 10 May 2023 | Classified by FDA | +40 days |
| 17 May 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H
Where it was distributed
International distribution in the countries of United Kingdom, Ireland and Turkey.
Questions about this recall
Is Pds¿ Plus Antibacterial (polydioxanone) Suture - Pds Plus Clr USP3-0(M2) S/A Pc-25 Prime recalled?
Yes. Ethicon recalled Pds¿ Plus Antibacterial (polydioxanone) Suture - Pds Plus Clr USP3-0(M2) S/A Pc-25 Prime on 31 Mar 2023. The recall is Class II and its status is Ongoing. Recall number Z-1571-2023.
Why was it recalled?
Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved
Which lots are affected?
UDI-DI: (01)10705031124691 Primary (Individual Unit); (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH
Where was it sold?
International distribution in the countries of United Kingdom, Ireland and Turkey.
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.
More recalls from Ethicon
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|---|---|---|---|---|---|
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| Device | CLASS II | Ethibond Excel Polyester Suture recalled by Ethicon | Ethicon | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Prolene Polypropylene Suture recalled by Ethicon | Ethicon | Lead & Heavy Metals | Nationwide |
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Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |