Lower riskMedical device recall · FDA · Published September 20, 2022
Ethicon STRATAFIX Sutures Recall: Risk of Tissue Trauma from Wrong Needle
Ethicon recalls STRATAFIX SPIRAL sutures that may contain a PS-1 needle instead of the intended SH taper point needle, potentially causing more tissue trauma. Affected products have specific product numbers and expiry dates.
Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
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Contact the company
📍Recalling firmEthicon, Inc.Us Highway 22 West · Somerville, NJ 08876
“Ethicon STRATAFIX Sutures Recall: Risk of Tissue Trauma from Wrong Needle.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60042-ethicon-stratafix-sutures-recall-risk-of-tissue-trauma-from-wrong. Based on FDA recall #Z-0150-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0150-2023%22&limit=1).
Ethicon, Inc. recalled STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH sutures on Sept. 20, 2022, after the FDA announced packages may contain an incorrect PS-1 cutting edge needle instead of the intended SH taper point needle. The Food and Drug Administration issued the Class II recall for products distributed internationally from China.
How to tell if you have it
Brand: Ethicon
Product: STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH
Product No.: SXMD1B405-12
Lot/Serial No.: B903HPU
Expiry Date: 08/21/2026
The hazard
The recall states that packages may contain a PS-1 cutting edge needle rather than the intended SH taper point needle. This error may result in more tissue trauma than anticipated for taper point needles, which could necessitate repair.
Context
GovInfoNow's records show ETHICON, INC. has 25 other recalls on record since 2017-08-17. Recent Ethicon recalls include a Monocryl Sutures Recall on 2024-10-08 involving incorrect needle type or size, and a Coated VICRYL Suture Recall on 2024-09-25 regarding needle pull-off and degradation. Other recent recalls of similar products include Covidien Dermalon 4-0 Blue 75cm Sutures Recall (2026-06-24), ConMed Suture Anchor Recall (2026-07-14), and Intuitive Surgical da Vinci S/Si Mega Needle Driver Recall (2025-12-09).
How to tell if you have this one
Check for product number SXMD1B405-12, UDI-DI 10705031228061, and lot/serial number B903HPU on the packaging. The product expires on 08/21/2026.
Brand
Ethicon
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for product number SXMD1B405-12, UDI-DI 10705031228061, and lot/serial number B903HPU on the packaging.
How this recall unfolded
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0150-2023 (September 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0150-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.