Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Recalled by Arobella Medical, LLC Due to This recall has been initiated because the Arobella...

Date: November 5, 2012
Company: Arobella Medical, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Arobella Medical, LLC directly.

Affected Products

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.

Quantity: 99

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Arobella Medical, LLC

Arobella Medical, LLC has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report