Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported May 17, 2023
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
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ethicon, Inc. recalled PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A P… - a moderate-severity action.
PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A P… was recalled by Ethicon, Inc. in May 17, 2023. Reason: Suture breakage during intra-operative use could result in poor performance of the impacted product because t…. Check the official notice for the remedy. Verify recall #Z-1571-2023 with the FDA Devices before acting.
The recall
Ethicon, Inc. issued this moderate-severity FDA Devices recall-Suture breakage during intra-operative use could result in poor performance of the impacted product because t….
- Moderate
- severity level
- Class II
- classification
- May 17, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1571-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1571-2023) was formally reported on May 17, 2023, with the manufacturer initiating the action on March 31, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ethicon, Inc. is listed as the recalling firm, operating out of Raritan, NJ. Federal records list the affected scope as 1,656 eaches (OUS only).
The documented reason for this recall is: 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 Distribution data in the federal record shows the product reached: International distribution in the countries of United Kingdom, Ireland and Turkey.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,656 eaches (OUS only)
Related Recalls
6
3 from same agency
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
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1571-2023 |
| Date reported | May 17, 2023 |
| Date initiated | March 31, 2023 |
| Recalling firm | Ethicon, Inc. |
| Firm location | Raritan, NJ |
| Affected scope | 1,656 eaches (OUS only) |
| Distribution | International distribution in the countries of United Kingdom, Ireland and Turkey. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1571-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ethicon, Inc.. Units affected: 1,656 eaches (OUS only).
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on May 17, 2023. Severity: Moderate. Recall number: Z-1571-2023.
Where was the recalled product distributed? ▼
Distribution: International distribution in the countries of United Kingdom, Ireland and Turkey..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1571-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 17, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.