Castile Soap Towelettes Recalled Due to Bacterial Contamination
FDA is recalling Castile soap towelettes in Foley trays and specimen kits due to bacterial contamination.
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: The recall is classified as FDA Class II, and the hazard involves bacterial contamination of a medical device used for patient care, which poses a risk of harm even without reported illnesses.
Plain-English summary
The U.S. Food and Drug Administration is recalling Castile soap towelettes included in Foley trays and midstream specimen kits. The recall is being conducted because the towelettes are contaminated with bacteria.
The affected product is the Covidien Dover EASY CATCH MIDSTREAM KT W/CAST, Item Code 25015. These towelettes are used to clean the genital area for male and female patients. The recall covers 74,300 kits distributed nationwide in the United States and to Canada.
Consumers should stop using the affected towelettes and contact the manufacturer or their healthcare provider for further instructions. The specific lot codes associated with this recall are 518151164X, 519450564X, 520850264X, 521250764X, 522951064X, 525150364X, and 525251064X.
The recalled product
- Product
- Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 74,300
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 recalled by Covidien LLC 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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