Class II — Ethicon Endo-Surgery Inc
| Recalling firm | ETHICON ENDO-SURGERY, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging. |
| Product | HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. |
| Quantity | 441,490 pieces |
| Distribution | Distributed US (nationwide) including the District of Columbia & Puerto Rico and in the countries of ARUBA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, ECUADOR, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, MEXICO, PANAMA, PERU, PHILIPPINES, SINGAPORE, SINGAPORE, THAILAND, TAIWAN & VIETNAM. |
| Initiated | 2015-09-23 |
| Classified | 2015-11-16 |
| Terminated | 2016-11-01 |
| Recall number | Z-0278-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ethicon Endo-Surgery Inc (Z-0278-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72285/
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