Model Number ASHA4730-01: Ambient HipVac 50 Wand with… recallZ-0579-2015 · ArthroCare Medical Corporation · initiated Oct 27, 2014
Class II Terminated All recalls posted in December 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ArthroCare Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential breach of sterile barrier due to defective product tray.
FDA root cause category: Package design/selection
What the company is doing
The firm notified their consignees on 10/29/14 via letter with a response form included. The letter requested the consignees discontinue use of the device and return it to the vendor.
Recall details
- Recall number
- Z-0579-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 27, 2014
- Posted by the FDA
- Dec 16, 2014
- Recalling firm
- ArthroCare Medical Corporation
- Quantity
- 23,119 devices
- Product code
- GEI
- FDA submissions
- K083306
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Austria, Australia, Belgium, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Ireland, Malaysia, Netherlands, Norway, Poland, Spain, South Africa, Sweden, Switzerland, Turkey, and UK.
Product description
Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Model Number ASHA4730-01 (HipVac) lot numbers: 1021255, 1021620, 1022188, 1022482, 1022636, 1023089, 1024067, 1025482, 1025480, 102481, 1025764, 1025765, 1026875, 1027163, 1027702, 1028327, 1029265, 1030025, 1031353, 1031759, 1031760, 1032765, 1032766, 1033773, 1033974, 1034227, 1034451, 1035036, 1035295, 1038550, 1039318, 1039903, 1042371, 1042370, 1043421, 1044678, 1045361, 1046599, 1047067, 1050441, 1053407, 1053408, 1052669, 1054471, 1056213, 1057010, 1055117, 1058810, 1058291, 1059396, 1061007, 1061008, 1064276, 1064641, 1065989, 1070710, 1070711, 1071321, 1071322, 1071360, 1071361, 1073431, 1073432, 1074079, 1074140, 1076027, 1077459, 1078013, 1078911 Model Number ASHA5050-01 (KVac) lot numbers: 1044887, 1050012, 1053720, 1054965, 1055700, 1068390, 1068391, 1068392, 1068393, 1076028, 1078916, 1078918
Other devices under the same FDA submission
2 devices cleared under K083306 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Coblation ASHA4830-01Smith & Nephew, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES121 reports
- Coblation ASH4830-01Smith & Nephew, Inc. · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES27 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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