ArthroCare Recalls 15 Coblator II Systems Due to Component Reversal
ArthroCare Medical Corporation is recalling 15 Coblator II systems because specific components were reversed on the controller boards.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or specific adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
ArthroCare Medical Corporation is recalling 15 units of the Coblator II System, Model RF8000E. This device is a bipolar, radiofrequency electrosurgical system used for soft tissue ablation, resection, and coagulation in otorhinolaryngology (ENT) surgery.
The recall was initiated after the contract manufacturer notified ArthroCare that the L2, L3, L4, or L5 components were reversed on the P/N09010 RoHS boards of the Coblator II Controller. The affected units were distributed nationwide in the states of Tennessee, Iowa, Arizona, Nebraska, South Dakota, New York, and Oklahoma.
Healthcare providers should stop using the affected units and contact ArthroCare Medical Corporation for instructions on how to return or repair the devices. The specific serial numbers for the recalled units are: CA0N0000FT, CA0N0000H0, CA0N0000H7, CA0N0000J6, CA0N0000KJ, CA0N0000KK, CA0N0000KL, CA0N0000FW, CA0N0000G5, CA0N0000G6, CA0N0000H1, CA0N0000FR, CA0N0000FZ, CA0N0000KF, and CA0N0000GH.
The recalled product
- Product
- Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller…
- Manufacturer
- ArthroCare Medical Corporation
- Hazard
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Serial Numbers: CA0N0000FT
- CA0N0000H0
- CA0N0000H7
- CA0N0000J6
- CA0N0000KJ
- CA0N0000KK
- CA0N0000KL
- CA0N0000FW
- CA0N0000G5
- CA0N0000G6
- CA0N0000H1
- CA0N0000FR
- CA0N0000FZ
- CA0N0000KF
- CA0N0000GH
Distribution
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