Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits
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 involves a medical device contaminated with bacteria, which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific lots of Aplicare Castile Soap towelettes. These towelettes are included in Foley Trays and Mid stream specimen kits and are used to clean the genital area for male and female patients.
The recall was initiated because the towelettes are contaminated with bacteria. The affected product is manufactured by Covidien LLC and was distributed nationwide in the United States and to Canada.
Consumers and healthcare facilities should stop using the affected towelettes. The specific lot codes for the recalled product are 525157164X, 524356164X, 522957364X, 522355664X, 521058064X, 520856764X, and 520159364X.
The recalled product
- Product
- Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 33,312
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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