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.
What this means for you
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.
- Hazard
- Affected units
- 3,562
Distribution
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