Laryngeal Mirror Weak Seal May Breach Sterility
Medline is recalling Centurion STERILE #5 Laryngeal Mirrors due to weak packaging seals that may not be detectable by users. The defect could result in a breach of the product's sterility if the seal fails.
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 recall of a sterile medical device with a defect that could compromise the critical safety function of maintaining product sterility. The hazard remains theoretical with no reported illnesses or injuries to date.
Plain-English summary
Medline Industries is recalling Centurion STERILE #5 Laryngeal Mirrors (Product Code 67830) worldwide due to defective packaging seals.
The affected medical devices may have weak seals that may not be detectable by users. If the seal fails, it could result in a breach of the sterility of the contents.
The recall affects product lot 2023042590, distributed across the United States, Panama, and Canada. Healthcare providers and facilities with this product should identify affected units by product code and lot number, and take appropriate precautions with affected inventory.
No illnesses or injuries have been reported to date. Consult the FDA recall notice Z-1432-2024 for further details and instructions on handling recalled product.
The recalled product
- Product
- Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Affected units
- 100
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)
- UDI/DI 10653160196648 (case)
- 00653160196641 (unit)
- Lot Numbers: 2023042590
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 29 recalled by MEDLINE INDUSTRIES, LP - Northfield 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.
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