The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0700-2023·Announced 2022-12-21

DeRoyal medical device anesthesia pack Class II recall across 23 states

DeRoyal Industries voluntarily initiated a Class II recall of 170 GEO-MED local anesthesia packs distributed across 23 US states. The specific safety concern is not detailed in the recall 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: FDA Class II medical device recall. Local anesthesia packs are inherently high-risk products where improper function could cause serious medical harm. Although no illnesses or injuries have been reported, the Class II classification indicates significant risk potential.

Plain-English summary

DeRoyal Industries Inc is recalling 170 kits of the GEO-MED LOCAL ANESTHESIA PACK (Reference 89-10800.01). The affected lot numbers are 56618893 (expiration 6/1/2024), 57002242 (expiration 6/1/2024), and 57187646 (expiration date appears truncated in source: 6/1/20).

The recalled kits were distributed throughout the United States to healthcare facilities in 23 states: Alabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Virginia, and Wisconsin.

This is a voluntary recall initiated by the manufacturer on November 3, 2022. The FDA classified this recall as Class II. No specific safety concern or defect is detailed in the available recall notice.

Customers or healthcare facilities with the indicated lot numbers should verify their inventory. The manufacturer, DeRoyal Industries Inc, is located in Powell, Tennessee. For further information or instructions regarding the affected kits, contact the manufacturer directly.

The recalled product

Product
GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Anesthesia Kits
Affected units
170

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 56618893 exp 6/1/2024
  • Lot 57002242 exp 6/1/2024
  • Lot 57187646 exp 6/1/20

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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