DeRoyal Myelogram Packs Recalled for Inclusion of Defective 3M Drapes
DeRoyal Industries is recalling 480 myelogram procedure packs because they contain 3M Steri Drapes that have been recalled. These packs were distributed to medical facilities in 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 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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is the inclusion of already-recalled 3M sterilization drapes in myelogram procedure packs. With no evidence of patient harm and a precautionary recall approach, this scores as Moderate.
Plain-English summary
DeRoyal Industries Inc is recalling 480 myelogram procedure packs (Model REF 89-9304.06, Lot 57913388, expiring 12/1/2026) because they contain 3M Health Care Steri Drapes that have been recalled.
The affected packs were distributed 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 recall is being conducted at the manufacturer level. Medical facilities with affected packs should verify their inventory using the provided lot number.
The recalled product
- Product
- DeRoyal MYELOGRAM PACK, REF 89-9304.06
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 480
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 57913388 exp 12/1/2026
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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