Ligamax 5 mm Endoscopic Multiple Clip Applier — Class II medical device recall Z-0656-2020
Terminated recall by Ethicon Endo-Surgery Inc, reported 2019-12-18, distributed nationwide. A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lid
| Recall number | Z-0656-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo-Surgery Inc, Blue Ash, OH, United States |
| Recall initiated | 2019-11-07 |
| Classified | 2019-12-06 |
| Reported by FDA | 2019-12-18 |
| Terminated | 2021-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, AW, BE, BR, CA, CH, CN, CO, DE, DK, EE, FI, FR, GB, ID, IE, IN, JP, KR, KW, MX, MY, NL, NZ, PA, PH, QA, SA, SE, SG, SI, TW |
| Quantity | 48,428 |
| Reason classes | sterility |
| 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 |
Product
Ligamax 5 mm Endoscopic Multiple Clip Applier
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0656-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.