The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0677-2023·Announced 2022-12-21

FDA recalls DeRoyal CRANI PACK medical device over defect

The FDA has recalled DeRoyal CRANI PACK devices (Lot 57389117, expiring 9/1/2026) due to a device defect. The recall affects 16 kits distributed across 23 US 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: This is an FDA Class II medical device recall. While no illnesses or injuries have been reported, Class II recalls involve device defects that could potentially cause harm to users. Per the severity rubric, such risk-of-harm products without reported injury warrant a High severity classification.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling DeRoyal CRANI PACK devices, Model Reference 89-10202.05, Lot 57389117 with expiration date 9/1/2026. A total of 16 kits have been recalled.

This Class II recall was initiated by the manufacturer, DeRoyal Industries Inc, on November 3, 2022. The recall is voluntary and manufacturer-initiated. The affected devices 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.

The specific defect or hazard requiring this recall is not detailed in available FDA documentation. Organizations or individuals in possession of affected devices should contact DeRoyal Industries Inc or the FDA for information regarding corrective actions or device return procedures.

The recalled product

Product
DeRoyal CRANI PACK, REF 89-10202.05
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Cranial Cooling Device
Hazard
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 57389117 exp 9/1/206

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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