Centurion Ear Speculum Sets Recalled for Weak Seal and Sterility Risk
Medline Industries is recalling Centurion ear speculum sets due to weak seals that could compromise sterility. The defect may not be detectable by users and could allow contamination 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 where a weak seal could compromise sterility, creating a risk of infection. No illnesses or injuries have been reported and the hazard depends on seal failure, placing it in the High category.
Plain-English summary
Medline Industries, LP is recalling 440 units of the Centurion STERILE ROUND EAR SPECULUM SET (Product Code I68505). The recalled lot numbers are 2023090190 and 2023101190. The product was distributed nationwide in the United States and to Panama and Canada.
The recall was initiated due to a weak seal on the speculum set packaging that may result in a breach of sterility if the seal fails. The weak seal may not be detectable by users, potentially allowing non-sterile contents to be used.
Healthcare facilities and end users should discontinue use of the recalled product and contact Medline Industries for replacement units. Inventory should be checked against the affected lot numbers.
The recalled product
- Product
- Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 440
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 (4)
- UDI/DI 00653160294453 (case)
- 10653160294450 (unit)
- Lot Numbers: 2023090190
- 2023101190
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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