The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0676-2023·Announced 2022-12-21

Medical Device Kit Recall: DeRoyal CRANI PACK Lot 56705261

DeRoyal Industries is recalling 16 units of the DeRoyal CRANI PACK (Lot 56705261, expiring 6/1/2025) distributed across multiple U.S. states. The specific reason for this Class II recall is not disclosed in the source 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 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: This is an FDA Class II medical device recall, which indicates a risk-of-harm product. No illnesses or injuries have been reported in the source material. Per the rubric, Class II medical device recalls without reported harm are scored as High.

Plain-English summary

DeRoyal Industries Inc is recalling 16 kits of the DeRoyal CRANI PACK, reference number 89-10202.03. The affected units are from Lot 56705261 with an expiration date of June 1, 2025. This is a Class II recall, indicating the FDA has determined the product poses a potential risk to users.

The recalled kits were distributed across 23 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.

This is a voluntary recall initiated by the manufacturer on November 3, 2022. The firm notified customers through multiple channels including email, fax, letter, press release, telephone, and direct facility visits.

Consumers in possession of the affected lot should discontinue use and contact DeRoyal Industries Inc or their healthcare provider for instructions regarding the recalled product.

The recalled product

Product
DeRoyal CRANI PACK, REF 89-10202.03
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Cranial Ice Pack
Affected units
16

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 56705261 exp 6/1/2025

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 →

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