Ethicon recalls Ligamax 5mm Endoscopic Clip Appliers with potential Tyvek lidding holes that could breach sterility. Affected lots include T93X4R through T94H78. Consumers should check product codes and lot numbers.
A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.
Take action
Contact the company
📍Recalling firmEthicon Endo-Surgery Inc4545 Creek Rd · Blue Ash, OH 45242-2803
“Ethicon Ligamax 5mm Clip Applier Recall: Sterility Risk from Tyvek Lidding Holes.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66550-ethicon-ligamax-5mm-clip-applier-recall-sterility-risk-from-tyvek. Based on FDA recall #Z-0656-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0656-2020%22&limit=1).
Ethicon Endo-Surgery Inc recalled Ligamax 5 mm Endoscopic Multiple Clip Appliers due to potential sterility breaches from holes in Tyvek lidding, the FDA said on Nov. 7, 2019. The agency announced the Class II recall under number Z-0656-2020.
How to tell if you have it
Brand: Ethicon
Product: Ligamax 5 mm Endoscopic Multiple Clip Applier
The recall addresses a potential that certain LIGAMAX devices in impacted lots may have small holes in the Tyvek lidding, which could result in a breach of sterility. The record does not report specific incidents or injuries.
Context
GovInfoNow's records show Ethicon Endo-Surgery Inc has 12 other recalls on record since Oct. 23, 2017. Other recent recalls include the Sept. 11, 2025 recall of Ethicon ECHELON LINEAR Cutters Reload 80mm Blue for an unsterilized risk and the April 22, 2025 recall of Ethicon Endopath Echelon Vascular White Reload for a risk of instrument lockout during surgery. Similar recent recalls of similar products include the Dec. 16, 2025 Vortex Disposable Forceps recall for possible sterile contamination and the June 9, 2026 Zimmer Sterile Tourniquet Hoses recall for sterility breach risk.
How to tell if you have this one
Check the product code (11EL5ML) and lot numbers listed in the recall notice: T93X4R through T94H78. The device is used in surgical settings and sold under Ethicon's brand.
Brand
Ethicon
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the product code (11EL5ML) and lot numbers (T93X4R to T94H78) to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US: Nationwide International: ARGENTINA ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHINA COLOMBIA DENMARK ESTONIA FINLAND FRANCE GERMANY INDIA INDONESIA IRELAND JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS NEW CALEDONIA NEW ZEALAND…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0656-2020 (November 7, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0656-2020 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.