Dental Rolls Recalled for Potential Sterility Breach from Weak Seal
Centurion Sterile Cotton Dental Rolls with weak seals may have compromised sterility. Affected products may 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: FDA Class II medical device with a potential sterility breach hazard. The risk is theoretical—contamination could occur if the seal fails—but without evidence of actual contamination or harm. Per the rubric, this qualifies as a risk-of-harm product without reported injury, scoring at most 3.
Plain-English summary
Medline Industries, LP is recalling Centurion STERILE COTTON DENTAL ROLLS (6/PK, Product Code 9125ST6) because the product packaging may have a weak seal that could compromise sterility. If the seal fails, the contents may become contaminated.
Affected Lot Numbers: 2023022290, 2023042490. The product has been distributed nationwide in the United States and in Panama and Canada.
Consumers and healthcare facilities using this product should stop use immediately and contact Medline Industries, LP for further guidance on return or replacement. Because the weak seal may not be immediately detectable by users, all packages from the affected lot numbers should be treated as potentially compromised.
The recalled product
- Product
- Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Dental
- 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 (4)
- UDI/DI 10653160129257 (case)
- 00653160129250 (each)
- Lot Numbers: 2023022290
- 2023042490
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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