The Recall Desk
ModerateFDA (Devices)·Z-0659-2023·Announced 2022-12-21

FDA Class II Recall: DeRoyal Lumbar/Cervical Pack devices

DeRoyal Industries Inc is recalling 360 units of LUMBAR/CERVICAL PACK (Reference 89-9521.11) medical devices. The firm initiated this voluntary Class II recall. No illnesses or injuries have been reported.

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: This is a voluntary Class II medical device recall with no reported illnesses or injuries. The combination of voluntary initiation, Class II classification (below Class I), and absence of reported harm indicates a moderate concern level per FDA classification standards.

Plain-English summary

DeRoyal Industries Inc has voluntarily initiated a Class II recall of its LUMBAR/CERVICAL PACK (Reference 89-9521.11), affecting 360 kits distributed across the United States. The recall was initiated on November 3, 2022, and FDA-classified on December 15, 2022.

The affected products are identified by the following lot numbers and expiration dates: Lot 56388673 (expires 6/1/2026), Lot 56842522 (expires 6/1/2026), Lot 57271485 (expires 9/1/2026), and Lot 57512154 (expires 11/1/2026). The kits were distributed to 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.

No illnesses or injuries have been reported in association with this recall. Healthcare providers and consumers who have received affected lot numbers should discontinue use and contact DeRoyal Industries Inc. for additional information and instructions.

The recalled product

Product
DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Therapeutic Pack
Affected units
360

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 (4)

  • Lot Numbers: Lot 56388673 exp 6/1/2026
  • Lot 56842522 exp 6/1/2026
  • Lot 57271485 exp 9/1/2026
  • Lot 57512154 exp 11/1/2026

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 →

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