Avanos Ballard Oral Care Swabs recalled for incorrect expiration date labeling
Avanos Medical is recalling Ballard Oral Care Swabs (codes 12241, 12243, 12251) due to incorrect expiration date labeling. The recall affects 5,475 cases distributed worldwide.
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: The source describes a labeling defect (incorrect expiration date) on a Class II medical device with no reported illnesses or injuries. This fits the rubric category of 'minor labeling errors' warranting a score of 2.
Plain-English summary
Avanos Medical, Inc. is recalling Ballard Oral Care Swabs (Product Codes 12241, 12243, and 12251) because the product labeling displays an incorrect expiration date.
The recalled products include 5,475 cases distributed worldwide, including the United States and Canada, Germany, Netherlands, France, Switzerland, Great Britain, Israel, and India. Detailed lot numbers are identified for each product code.
Consumers and healthcare facilities who have the affected products should verify their lot numbers against the recall notice and contact Avanos Medical for guidance on correct expiration dates.
The recalled product
- Product
- Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
- Manufacturer
- Avanos Medical, Inc.
- Category
- Medical Device — Oral Care
- Hazard
- Affected units
- 5,475
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 (20)
- a) 12241
- Lot Numbers: 20067528
- 20069614
- 20077132
- 20079287
- 20079286
- 20079285
- 20079284
- 20079283
- 20079282
- 20082126
- 20082118
- 20082119
- 20082120
- 20082121
- 20082122
- 20086314
- b) 12243
- Lot Numbers: 20050262
- 20050263
Distribution
Distributed nationwide across the United States.
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