---
title: "PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3... — FDA record Z-1571-2023 | Is It on Recall"
description: "Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or"
url: https://isitonrecall.com/recall/fda-device-z-1571-2023-pds-plus-antibacterial-polydioxanone-suture-pds-plus-clr-27in-70cm-usp3-0-m2-s-a-pc-25-prime-intende/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use... — FDA record Z-1571-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 31, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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
- **Reason**: 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
- **Classification**: Class II
- **Recalling firm**: Ethicon, Inc.
- **Quantity**: 1,656 eaches (OUS only)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1571-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1571-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: (01)10705031124691 Primary (Individual Unit); (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: May 17, 2023
- **Recall initiation date**: Mar 31, 2023
- **Center classification date**: May 10, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1571-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Ethicon, Inc. records](https://isitonrecall.com/brand/ethicon-inc/)