Z-0656-2020Class II

Ligamax 5 mm Endoscopic Multiple Clip Applier

Name: Z-0656-2020 Ligamax 5 mm Endoscopic Multiple Clip Applier
Creator: Ethicon Endo-Surgery Inc
Published: 2019-11-07
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2019-11-07 / Terminated / root cause: packaging

FDA source

Ethicon Endo-Surgery Inc began a recall of Ligamax 5 mm Endoscopic Multiple Clip Applier on 2019-11-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0656-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-07
Posted: 2019-12-06
Terminated: 2021-04-23
Recalling firm: Ethicon Endo-Surgery Inc
Product: Ligamax 5 mm Endoscopic Multiple Clip Applier
Product code: FZP Clip, Implantable
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On November 7, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: URGENT: MEDICAL DEVICE RECALL (REMOVAL) LIGAMAX 5mm Endoscopic Multiple Clip Applier Product Codes: EL5ML (Multiple Lot Numbers) Dear Valued Customer Ethicon has initiated a voluntary medical device recall (removal) of specific lots of LIGAMAX 5mm Endoscopic Multiple Clip Applier. Ethicon identified that 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. In the event that the sterility barrier has been breached, there is a chance that a pathogen may be introduced and if unrecognized or untreated may cause life threatening infection. As the population at risk is most likely to receive prophylactic antibiotics the probability of harm is extremely rare. We have identified the root cause and have implemented corrective actions to address the issue and prevent reoccurrence. As of the date of this communication, no adverse events or complaints have been reported for this issue. Our records indicate that you may have ordered or received product subject to this recall. PLEASE DISTRIBUTE THIS INFORMATION TO ALL STAFF WITHIN YOUR FACILITY WHO USE LIGAMAX 5mm ENDOSCOPIC MULTIPLE CLIP APPLIER. The dates of distribution for affected products were from July 31, 2019 thru October 4, 2019. EFFECTIVE IMMEDIATELY DO NOT USE OR DISTRIBUTE THE FOLLOWING PRODUCT CODE/ LOT: Product Name: LIGAMAX Product Code: EL5ML Product Lots: T93X4R, T93X9D, T93Y2Z, T93Y70, T93Y96, T93Z52, T93Z76, T9401C, T9408F T94118, T9416M, T9422K, T9426Z, T94402, T94536, T94567, T9461M, T94667, T94721, T94758, T94807, T9484Y, T9487J, T9491A, T94A9K, T94C2Z, T94C8N, T94D2N, T94E66, T94F3C, T94F7F, T94G99, T94H1N T94H78 Description/Size: 5mm Endoscopic Multiple Clip Applier Note: This recall is specific to lots described. Health care practitioners who have treated pat
Quantity in commerce: 48,428
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 PANAMA PHILIPPINES PUERTO RICO QATAR SAUDI ARABIA SINGAPORE SLOVENIA SWEDEN SWITZERLAND TAIWAN UK
Product codes and lots: Product Code: 11EL5ML Lot Numbers: T93X4R, T93X9D, T93Y2Z, T93Y70, T93Y96, T93Z52, T93Z76, T9401C, T9408F, T94118, T9416M, T9422K, T9426Z, T94402, T94536, T94567, T9461M, T94667, T94721, T94758, T94807, T9484Y, T9487J, T9491A T94A9K, T94C2Z, T94C8N, T94D2N, T94E66, T94F3C, T94F7F, T94G99 T94H1N, T94H78

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0656-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0656-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-06

Product code FZP

K110699Class IILigamax 5Ethicon Endo-Sugery, LLC / cleared 2011-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)