Ethicon, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1571-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 31, 2023

Date Posted: May 17, 2023

Recall Number: Z-1571-2023

Event ID: 92084

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

Status: Ongoing

Product Quantity: 1,656 eaches (OUS only)

Code Information:

UDI-DI: (01)10705031124691 Primary (Individual Unit); (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH

Distribution Pattern:

International distribution in the countries of United Kingdom, Ireland and Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated