FDA Recalls Unapproved Advanced Orthogonal Percussion Adjusting Instruments
The FDA is recalling 54 Advanced Orthogonal Percussion Adjusting Instruments because they are unapproved medical devices. The recall covers units distributed nationwide to chiropractors.
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. The source text identifies the device as 'unapproved' but does not report any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving regulatory non-compliance without immediate reported harm.
Plain-English summary
Advanced Orthogonal Equipment, Incorporated is recalling 54 units of the Advanced Orthogonal Percussion Adjusting Instrument. The device is indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra. The recall is being conducted because the device is an unapproved medical device.
The affected units were distributed nationwide in the United States, including the states of Alabama, California, Colorado, Florida, Georgia, Idaho, Kentucky, Maryland, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Virginia, and Washington. The recall includes specific serial numbers ranging from 001 to 061, with certain numbers excluded.
Consumers and healthcare providers should stop using the recalled devices. Advanced Orthogonal Equipment, Incorporated is the recalling firm responsible for the recall action.
The recalled product
- Product
- Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.
- Manufacturer
- Advanced Orthogonal Equipment, Incorporated
- Hazard
- Affected units
- 54
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 (20)
- Serial numbers: 001
- 002
- 008
- 007
- 006
- 0010
- 009
- 011
- 016
- 015
- 014
- 023
- 017
- 018
- 019
- 020
- 021
- 024
- 025
- 022
Distribution
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