Arobella Medical 6mm Qurette used with the Arobella Medical AR1000… — Class II medical device recall Z-0534-2013
Terminated recall by Arobella Medical, LLC, reported 2012-12-26, distributed nationwide. This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can frac
| Recall number | Z-0534-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arobella Medical, LLC, Minnetonka, MN, United States |
| Recall initiated | 2012-11-05 |
| Classified | 2012-12-17 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2015-03-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | SA |
| Quantity | 99 |
| Reason classes | device malfunction |
Product
Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product Usage: The Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue, wound debridement ( of acute and chronic wounds, burns, and diseased or necrotic tissue), and cleansing irrigation of the wound site for the removal of debris, exudates, fragments, and other matter.
Reason for recall
This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. The 6 mm Qurette is a component of the AR1000 Quostic Wound Therapy System.
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-0534-2013. 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.