The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0576-2023·Announced 2022-12-21

GEO-MED Plastic Hand Pack Medical Device Recall (Class II)

DeRoyal Industries Inc initiated a voluntary recall of 165 kits of GEO-MED Plastic Hand Pack RF distributed across 23 US states. The specific reason for the Class II recall was not provided in the FDA 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: This is a voluntary Class II medical device recall with no reported illnesses, injuries, or deaths. The specific hazard reason was not stated in the source material. Per the severity rubric, voluntary recalls without reported harm and theoretical hazards are classified as Moderate.

Plain-English summary

DeRoyal Industries Inc, headquartered in Powell, Tennessee, initiated a voluntary Class II recall of its GEO-MED PLASTIC HAND PACK RF (REF 89-6667.09) medical device. A total of 165 kits were affected.

Three lot numbers were identified in the recall: Lot 56073840 (expiration 8/1/2022), Lot 56617675 (expiration 4/21/2023), and Lot 57001291 (expiration 1/1/2023). The product was 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 FDA classified this as a Class II recall. No reported illnesses, injuries, or deaths were documented in the recall notice. The specific reason for the recall was not provided in the FDA's public recall statement.

The recalled product

Product
GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Rehabilitation Equipment
Affected units
165

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 (3)

  • Lot Numbers: Lot 56073840 exp 8/1/2022
  • Lot 56617675 exp 4/21/2023
  • Lot 57001291 exp 1/1/2023

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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