Class II — Ethicon, Inc.
| Recalling firm | ETHICON INC. |
|---|---|
| Registered facility | View this company's 11 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of MERSILENE" Tape product codes are being supplied with an incorrect Instructions for Use (IFU) insert. |
| Product | ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) |
| Quantity | 396,024 eaches |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico. |
| Initiated | 2016-08-01 |
| Classified | 2016-09-27 |
| Terminated | 2017-11-29 |
| Recall number | Z-2889-2016 |
| 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, Inc. (Z-2889-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74901/
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