Ethicon STRATAFIX Spiral Sutures Recall: Incorrect Needle Risk
Ethicon recalls specific STRATAFIX Spiral PGA-PCL sutures due to possible incorrect needle size or length in some lots. Affected products may cause improper surgical use if not checked.
Lower-risk recall
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Contact the company
What happened, in plain English
Ethicon is recalling certain STRATAFIX Spiral sutures that may have the wrong needle size or length due to a manufacturing mix-up. This could lead to improper surgical use if the sutures are not checked before use. Read more at govinfonow.com/recall/60899-ethicon-stratafix-spiral-sutures-recall-incorrect-needle-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/60899-ethicon-stratafix-spiral-sutures-recall-incorrect-needle-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1053-2022
Cite this page
“Ethicon STRATAFIX Spiral Sutures Recall: Incorrect Needle Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60899-ethicon-stratafix-spiral-sutures-recall-incorrect-needle-risk. Based on FDA recall #Z-1053-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1053-2022%22&limit=1).
Why it’s dangerous
The recalled sutures may contain the wrong needle type or size, and incorrect suture length due to a component mix-up during manufacturing. This could lead to improper surgical use if the sutures are not checked before use.
Who’s affected
Surgical professionals using the recalled STRATAFIX Spiral sutures for procedures. Patients at risk if the incorrect sutures are used during surgery.
How to tell if you have this one
Check the product code on the packaging: SXMD1B403-12 for 20cm sutures and SXMD1B100-12 for 30cm sutures. Look for lot numbers AAHM529 or AAHQ049 on the packaging.
- Brand
Ethicon- Product
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A- Category
Medical device
What to do — step by step
Check Product Details
Verify the product code and lot number on the packaging to confirm if the item is affected.
How this recall unfolded
Recall timeline
FDA published this recall 55 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1053-2022 (March 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1053-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.