The Recall Desk
ModerateFDA (Devices)·Z-0702-2023·Announced 2022-12-21

Medical Device Recall: DeRoyal NEURO SPINE BACK PACK Kit

DeRoyal Industries Inc is recalling 180 kits of the NEURO SPINE BACK PACK PGYBK distributed across multiple U.S. states. The specific reason for the recall is not documented in the agency filing.

What this means for you

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: Class II medical device recall with no reported illnesses or injuries. The specific defect is not documented in the recall notice, preventing risk assessment.

Plain-English summary

DeRoyal Industries Inc initiated a voluntary recall of 180 kits of the NEURO SPINE BACK PACK PGYBK (REF 89-10853.01) beginning November 3, 2022. The affected product corresponds to lot number 57187574 with an expiration date of April 1, 2024.

The specific defect or hazard prompting the recall is not detailed in the available recall documentation. The product was distributed across 23 U.S. states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.

Consumers who possess affected kits should contact DeRoyal Industries Inc for instructions on proper handling or replacement. Healthcare facilities and distributors should verify their inventory against the lot number and expiration date to identify affected units.

The recalled product

Product
DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01
Manufacturer
DeRoyal Industries Inc

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 (1)

  • Lot Numbers: Lot 57187574 exp 4/1/2024

Distribution

Distribution scope not specified by the agency.