Medline Alcohol Swabsticks Recalled for Weak Seal Compromising Sterility
Medline is recalling alcohol swabsticks that may have weak seals potentially compromising product sterility. The defect may not be visible to users.
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 compromise hazard due to weak seals. No illnesses or injuries have been reported, making this a theoretical risk-of-harm scenario affecting a sterilized medical consumable.
Plain-English summary
Medline Industries, LP is recalling MEDLINE SWABSTICKS ALCOHOL 3PK (Product code DYNDA2723). The products have a manufacturing defect affecting the seal.
The affected products have been distributed worldwide, including across the United States, Panama, and Canada. Product identification: UDI 20193489190844 (case level) and 10193489190847 (each); lot number 2023071290 was not distributed.
The products may have a weak seal, which may result in a breach of sterility of the contents if the seal fails. This weak seal defect may not be detectable by all users.
Contact Medline Industries for return or replacement instructions if you have received the affected product.
The recalled product
- Product
- MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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 (2)
- UDI/DI 20193489190844 (case)10193489190847 (each)
- Lot Numbers: 2023071290 (not distributed)
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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