Agency classClass IIOur severity:High FDA (Devices)·Z-2617-2023·Announced 2023-09-27

PDS II Surgical Sutures Recalled for Tensile Strength Defect

ETHICON is recalling specific lots of PDS II surgical sutures after internal testing confirmed some units did not meet tensile strength requirements. Approximately 868,363 units were distributed in the United States and globally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a confirmed manufacturing defect in a critical surgical device. No adverse events or injuries are reported in the source text. The defect poses a risk of harm to surgical patients, meeting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

ETHICON, LLC is recalling specific lots of PDS II (polydioxanone) sutures. Approximately 868,363 units from the affected lots were distributed in the United States and globally. Internal testing confirmed that some units from these lots did not meet the required tensile strength standard.

Surgical sutures that do not meet tensile strength requirements may not properly support surgical wounds and could compromise the effectiveness of wound closure.

Healthcare facilities and providers should immediately discontinue use of the affected product lots. Patients who received sutures from these lots should contact their healthcare provider with any concerns about wound healing or complications. The FDA website provides detailed information about affected product numbers and lot numbers.

The recalled product

Product: PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z416H-50…
Manufacturer: ETHICON, LLC
Category: Medical Device — Surgical Sutures
Hazard: tensile-strength-failure
Affected units: 868,363

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDI-DI: 10705031026742
10705031031234
10705031032620
10705031033894
10705031134386
10705031134492
10705031118102
10705031073487
10705031149410
10705031149427
10705031075443
10705031149441
10705031149472
10705031086906
10705031130296
10705031130302
10705031082960
10705031151819
10705031130333
10705031130357

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by ETHICON, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · ETHICON, LLC

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Same hazard · tensile strength failure