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.
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 3/5 (High).
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
- Affected units
- 96
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
Part of a larger recall action
This product is one of 156 recalled by DeRoyal Industries Inc 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.
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