Class II — Megadyne Medical Products, Inc.
| Recalling firm | Megadyne Medical Products, Inc. |
|---|---|
| Registered facility | MEGADYNE MEDICAL PRODUCTS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation. |
| Product | E-Z Clean® Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek® - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated. |
| Quantity | 1816 |
| Distribution | Class II Recall - Worldwide Distribution - US including the states of CA, HI, IL, MN, NC, NJ, OH, PA, TX, UT and VA. |
| Initiated | 2013-08-07 |
| Classified | 2013-08-27 |
| Terminated | 2014-01-28 |
| Recall number | Z-2097-2013 |
| 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 — Megadyne Medical Products, Inc. (Z-2097-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65995/
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