Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1934-2013·Announced 2013-08-21

Medtronic Xomed Recalls ENT Surgical Instrument Trays for Labeling Defects

Medtronic Xomed is recalling 3,562 ENT surgical instrument trays to replace them with units featuring improved 'PREVACUUM ONLY' labeling.

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: The recall is classified as FDA Class II, but the source text describes a labeling correction ('PREVACUUM ONLY') without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving labeling errors or precautionary measures where no harm is reported.

Plain-English summary

Medtronic Xomed, Inc. is recalling 3,562 Tray Surgical, ENT instrument trays. These trays are used for the storage and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures. The recall covers all lots of specific models, including the 2 Level Instrument tray, 3 Level tray, House Otology Set tray, and various other ENT-specific trays.

The recall is being conducted to replace the identified instrument trays in the field with trays that have improved labeling. The replacement trays include lids that contain the statement indicating 'PREVACUUM ONLY'. The source text does not specify a particular illness, injury, or failure event that triggered the recall, but rather focuses on the correction of the labeling on the lids.

The affected trays were distributed nationwide in the United States, including Hawaii, Puerto Rico, and Guam, as well as internationally to numerous countries across North America, South America, Europe, Asia, Africa, and the Middle East. Healthcare facilities and users of these surgical trays should contact Medtronic Xomed to arrange for the replacement of the affected units with the corrected versions.

The recalled product

Product: Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.
Manufacturer: Medtronic Xomed, Inc.
Category: Medical Device — Surgical Instruments
Hazard: mis-labeling
Affected units: 3,562

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Same manufacturer · Medtronic Xomed, Inc.

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