Dynarex Lemon Glycerin Swabs recalled due to temperature exposure
Dynarex lemon glycerin swabs distributed nationwide may have reduced effectiveness due to temperature excursions prior to delivery. All lots received between June 1 and September 30, 2021 are affected.
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 2/5 (Moderate).
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: This FDA Class II recall involves potential product degradation from temperature exposure, with no reported illnesses or injuries. The hazard is theoretical rather than immediate, and the product is a non-critical comfort item, fitting the pattern of a precautionary recall.
Plain-English summary
Dynarex lemon glycerin swabs (Catalog #1216, packaged 3 per unit, 25 units per box, 10 boxes per case) manufactured by Mckesson Medical-Surgical Inc. are being recalled.
The swabs were exposed to temperature excursions between June and August 2021 prior to delivery. These higher temperatures may have impacted the product's effectiveness.
Approximately 135.08 boxes were distributed nationwide. All lots received between June 1 and September 30, 2021 are included in the recall.
The recalled product
- Product
- Dynarex SWAB, LEMON GLYCERIN (3/PK 25PK/BX 10BX/CS) DYNREX Catalog # 1216
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Medical Device
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 (1)
- GTIN: Not available
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 55 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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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