CLASS II ONGOING Device recall · Reported 27 Sep 2023 · FDA Enforcement Report

PDS Plus Antibacterial (polydioxanone) Suture recalled by Ethicon

Ethicon is recalling PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, distributed nationwide in the US. The recall was initiated on 10 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 10705031122574, 10705031047952, 10705031048232, 10705031048294, 10705031048300, 10705031048393, 10705031123786, 10705031048447, 10705031123854, 10705031123854, 10705031123861, 10705031203969, 10705031203983, 10705031204010, 10705031204034, 10705031048546, 10705031048553, 10705031124059, 10705031124677, 10705031124691, 10705031124707, 10705031124714, 10705031124752, 10705031124752, 10705031124769, 10705031124875, 10705031124899, 10705031123540, 10705031123564, 10705031123588, 10705031123595; Lot Numbers: RLMCKU, RLMEAL, RLMDST, RMMHLT, RJMMAC, SCMASA, RKMQDX, RKMBEB, SAMERU

Quantity recalled868,363 total 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-2616-2023
FDA event ID: 92843
Recalling firm: Ethicon, Guaynabo, PR
Classification: Class II
Status: Ongoing
Recall initiated: 10 Aug 2023
FDA classified: 20 Sep 2023
Reported: 27 Sep 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

10 Aug 2023	Recall initiated by company
20 Sep 2023	Classified by FDA	+41 days
27 Sep 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

Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

Product as listed by the FDA

PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625H40, PDP9626H40, PDP9631H40, PDP9715H15, PDP9715H40, PDP9733H16, PDP9861H40, PDP9865H40, XWPDP421H40, XWPDP423H40, XWPDP442H40, XWPDP443H16

Where it was distributed

US Nationwide. Global Distribution.

Nationwide

Questions about this recall

Is PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50 recalled?

Yes. Ethicon recalled PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50 on 10 Aug 2023. The recall is Class II and its status is Ongoing. Recall number Z-2616-2023.

Why was it recalled?

Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

Which lots are affected?

UDI-DI: 10705031122574, 10705031047952, 10705031048232, 10705031048294, 10705031048300, 10705031048393, 10705031123786, 10705031048447, 10705031123854, 10705031123854, 10705031123861, 10705031203969, 10705031203983, 10705031204010, 10705031204034, 10705031048546, 10705031048553, 10705031124059, 10705031124677, 10705031124691, 10705031124707, 10705031124714, 10705031124752, 10705031124752, 10705031124769, 10705031124875, 10705031124899, 10705031123540, 10705031123564, 10705031123588, 10705031123595; Lot Numbers: RLMCKU, RLMEAL, RLMDST, RMMHLT, RJMMAC, SCMASA, RKMQDX, RKMBEB, SAMERU

Where was it sold?

US Nationwide. Global Distribution.

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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