The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0647-2023·Announced 2022-12-21

FDA Class II Recall of DeRoyal Myelogram Pack Kits

DeRoyal Industries voluntarily recalled 2,280 myelogram pack kits across 23 U.S. states. No specific reason for the recall was provided in the official notice.

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: FDA Class II recalls indicate moderate risk. This is a voluntary, firm-initiated recall with no reported illnesses or injuries mentioned in the source material, supporting a moderate rather than severe classification.

Plain-English summary

DeRoyal Industries Inc is voluntarily recalling the DeRoyal Myelogram Pack, Reference 89-9304.05, affecting 2,280 kits distributed to healthcare facilities 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.

The specific reason for this recall was not provided in the FDA notice. The affected lot numbers and their expiration dates are: Lot 55612944 (expires 3/1/2026), Lot 56615881 (expires 7/1/2026), Lot 56279557 (expires 5/1/2026), Lot 57185350 (expires 7/1/2026), and Lot 57591593 (expires 1/1/2025).

Healthcare facilities and individuals who have received kits with these lot numbers should consult with DeRoyal Industries or the FDA for further guidance. The recall was initiated on November 3, 2022, and remains ongoing as of the latest update.

The recalled product

Product
DeRoyal MYELOGRAM PACK, REF 89-9304.05
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Diagnostic Kit
Affected units
2,280

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 (5)

  • Lot Numbers: Lot 55612944 exp 3/1/2026
  • Lot 56615881 exp 7/1/2026
  • Lot 56279557 exp 5/1/2026
  • Lot 57185350 exp7/1/2026
  • Lot 57591593 exp 1/1/2025

Distribution

Distributed in 23 states:

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.

See all 156 products in this recall →

Related recalls

Same manufacturer · DeRoyal Industries Inc

See all →

Similar recalls