E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and… — Class II medical device recall Z-2097-2013
Terminated recall by Megadyne Medical Products, Inc., reported 2013-09-04, distributed in CA, HI, IL, MN, NC, NJ, OH, PA…. Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem a
| Recall number | Z-2097-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Megadyne Medical Products, Inc., Draper, UT, United States |
| Recall initiated | 2013-08-07 |
| Classified | 2013-08-27 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2014-01-28 |
| Distributed | CA, HI, IL, MN, NC, NJ, OH, PA, TX, UT, VA |
| Quantity | 1,816 |
| Lot numbers | 131508, 131509, 131945, 131946, 132058, 132167, 132396 |
| Model numbers | 0100L, 0100LS, 131508, 131509, 131945, 131946, 132058, 132167, 132396 |
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.
Reason for recall
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.
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-2097-2013. 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.