The Recall Desk
HighFDA (Devices)·Z-0591-2023·Announced 2022-12-21

DeRoyal procedure packs recalled for containing affected Steri Drapes

DeRoyal Industries is recalling its BASIC NEURO PACK procedure packs because they contain 3M Health Care Steri Drapes that have been recalled. The recall affects 96 kits (lot 57287655, expires 9/1/2026) distributed to 23 states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries and theoretical hazard. This is a risk-of-harm medical device where injury has not been reported, matching the High severity criteria.

Plain-English summary

DeRoyal Industries Inc. is recalling BASIC NEURO PACK procedure packs (REF 89-7258.12) because they contain 3M Health Care Steri Drapes that have been subject to recall.

The affected lot is Lot 57287655 with an expiration date of September 1, 2026. A total of 96 kits were distributed to healthcare facilities across 23 US 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.

The FDA has classified this as a Class II recall. Specific information about the underlying hazard related to the 3M Steri Drapes is not provided in this notice.

The recalled product

Product
DeRoyal BASIC NEURO PACK, REF 89-7258.12
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Procedure Packs

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 57287655 exp 9/1/2026

Distribution

Distribution scope not specified by the agency.

Related recalls

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