Ethicon recalls STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle sutures due to failing internal strength tests. Affected products have product code SXPP1B401 and lot number MMH401. Consumers should contact Ethicon for details.
“Ethicon STRATAFIX Spiral PDS Plus Violet 27 Suture Recall: Strength Testing Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67224-ethicon-stratafix-spiral-pds-plus-violet-27-suture-recall-strength. Based on FDA recall #Z-0048-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0048-2020%22&limit=1).
Ethicon, Inc. recalled STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle sutures on Aug. 13, 2019, because the product does not meet internal strength testing specifications, according to the FDA.
The recalled sutures do not meet certain internal strength testing specifications, according to the FDA.
Context
GovInfoNow's records show ETHICON, INC. has had 25 other recalls on record since Aug. 17, 2017. Other recent recalls of similar products include Ethicon Monocryl Plus Suture Recall (May 10, 2024), Ethicon Coated VICRYL Suture Recall (Sept. 25, 2024), and Ethicon Monocryl" Sutures Recall (Oct. 8, 2024).
How to tell if you have this one
Check for product code SXPP1B401 and lot number MMH401 on the suture packaging. This specific suture is sold under the brand Ethicon.
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
States: IN MD AR IL GA TN NJ PA NC CA OK CO KS UT KY WA OH OR OUS: Australia Hong King India Japan Korea Singapore Thailand United States
Recall number
Product, codes & lots
Quantity
Z-0047-2020
STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture; Lot # LPH946 GTIN: 10705031235823
416 each
Z-0048-2020
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture; Lot # MMH401 GTIN: 10705031236042
852 each
Based on the official FDA remedy
What to do — step by step
Contact Ethicon
Reach out to Ethicon directly for specific instructions on handling the recalled product.
Where it went and when
Where it was distributed
Distributed in 18 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “States: IN MD AR IL GA TN NJ PA NC CA OK CO KS UT KY WA OH OR OUS: Australia Hong King India Japan Korea Singapore Thailand United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
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-0048-2020 (August 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0048-2020 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.