The Recall Desk
ModerateFDA (Devices)·Z-0590-2023·Announced 2022-12-21

DeRoyal BASIC NEURO PACK kits recalled due to 3M Steri Drapes recall

DeRoyal BASIC NEURO PACK procedure kits are recalled because they contain 3M Health Care Steri Drapes that were previously recalled. 108 kits were distributed across multiple US states.

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: FDA Class II recall with no reported illnesses or injuries. The hazard relates to recalled components within the kit, representing a precautionary secondary recall.

Plain-English summary

DeRoyal Industries Inc is recalling DeRoyal BASIC NEURO PACK procedure kits (Reference 89-7258.10). A total of 108 kits have been affected by this recall.

These procedure packs contain 3M Health Care Steri Drapes that have been separately recalled. The FDA classified this as a Class II recall (number Z-0590-2023).

The affected kits were distributed across 23 US states including 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. The affected lot number is 56777564 with an expiration date of May 1, 2026.

For more information about this recall, reference FDA recall number Z-0590-2023 or contact DeRoyal Industries Inc.

The recalled product

Product
DeRoyal BASIC NEURO PACK, REF 89-7258.10
Manufacturer
DeRoyal Industries Inc
Hazard
  • recalled-component

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 56777564 exp 5/1/2026

Distribution

Distribution scope not specified by the agency.