Ethicon Endo-Surgery Inc: Ligamax 5 mm Endoscopic Multiple Clip Applier

Recall number

Z-0656-2020

Recalling firm

Ethicon Endo-Surgery Inc

Product

Ligamax 5 mm Endoscopic Multiple Clip Applier

Status

Terminated

Initiated

2019-11-07

Posted

not on file

Terminated

2021-04-23

Reason

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

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

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

Lot, serial or model codes

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

510(k) numbers

["K110699"]

PMA numbers

not on file

Product code

FZP

Firm FEI

1527736

Firm city

Blue Ash

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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