EVac 70 XTRA with Integrated Cable and PROcise EZ View with… — Class II medical device recall Z-2105-2015
Terminated recall by ArthroCare Corporation, reported 2015-07-29, distributed nationwide. Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifi
| Recall number | Z-2105-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ArthroCare Corporation, Austin, TX, United States |
| Recall initiated | 2015-06-02 |
| Classified | 2015-07-17 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2016-06-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, DE, ES, GB, IE, IN, IT, SG |
| Quantity | 733 devices |
| Lot numbers | 1091254, 1093290 |
Product
EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction be reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.
Reason for recall
Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.
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-2105-2015. 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.