Ethicon PDS Plus Suture Recall: Tensile Strength Issue
Ethicon recalls PDS Plus Antibacterial Suture (PDP493G) due to insufficient tensile strength. Affected units may fail during use, risking complications. Contact Ethicon for details.
Lower-risk recall
Products do not meet a tensile strength specification
Contact the company
What happened, in plain English
Ethicon is recalling a specific antibacterial suture product because it doesn't meet the required strength standards. This could lead to the suture breaking during medical procedures, potentially causing complications for patients. Read more at govinfonow.com/recall/70877-ethicon-pds-plus-suture-recall-tensile-strength-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/70877-ethicon-pds-plus-suture-recall-tensile-strength-issue · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2533-2018
Cite this page
“Ethicon PDS Plus Suture Recall: Tensile Strength Issue.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70877-ethicon-pds-plus-suture-recall-tensile-strength-issue. Based on FDA recall #Z-2533-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2533-2018%22&limit=1).
Why it’s dangerous
The suture does not meet the required tensile strength specifications, meaning it may break under normal use during medical procedures. This could lead to complications such as incomplete wound closure or tissue damage.
Who’s affected
Medical professionals and patients who have received this specific suture product are affected. The risk is low for most users as the issue is related to product specifications rather than immediate danger.
How to tell if you have this one
Check for the product code PDP493G (GTIN 10705031203945) and lot number MCZ162 on the packaging. This suture is sold under the brand Ethicon.
- Brand
Ethicon- Product
PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Japan
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2532-2018 | PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983); Lot Number: MBK743 | 4992 |
| Z-2533-2018 | PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945); Lot Number:MCZ162 | 756 |
| Z-2534-2018 | PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347); Lot Number: MCZ363 | 72 |
What to do — step by step
Check Product Details
Look for the product code PDP493G (GTIN 10705031203945) and lot number MCZ162 on the packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2533-2018 (June 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2533-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.