The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1083-2019·Announced 2019-04-10

Advanced Bionics Recalls Four Naída CL Q30 Sound Processors

Advanced Bionics is recalling four Naída CL Q30 sound processors because they were loaded with incorrect firmware. The devices were distributed in North Carolina and several foreign countries.

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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Advanced Bionics, LLC is recalling four Naída CL Q30 Sound Processors in Sand Beige, Silver Gray, and Velvet Black. The recall involves specific model numbers Cl-5260-120, Cl-5260-140, and Cl-5260-150. The devices were recalled because they were loaded with the incorrect firmware.

The affected sound processors were distributed to North Carolina and foreign locations including Canada, Argentina, Germany, South Africa, Egypt, Kuwait, and Iran. There was no government or military distribution. The recall covers four specific units identified by their serial numbers and Unique Device Identification (UDI) codes.

Consumers who possess these specific sound processors should contact Advanced Bionics for further instructions. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
Manufacturer
Advanced Bionics, LLC
Category
Medical Device — Hearing Aid
Hazard
Affected units
4

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 (8)

  • Model Cl-5260-120 - Serial number 1047584
  • UDI (01)07630016838057(11)180309(21)1045784
  • Model Cl-5260-140 - Serial number 1047481
  • UDI (01)07630016829710(11)151208(21)1047481
  • and Serial number 1047482
  • UDI (01)07630016829710(11)151208(21)1047482
  • and Model Cl-5260-150 - Serial number 1082276
  • UDI (01)07630016838071(11)180925(21)1082276.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Advanced Bionics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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