The Recall Desk
HighFDA (Devices)·Z-1201-2016·Announced 2016-03-30

Castile Soap Towelettes Recalled Due to Bacterial Contamination

FDA is recalling Castile soap towelettes in Foley trays and midstream kits due to bacterial contamination.

What this means for you

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 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 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 products are manufactured by Covidien LLC. The specific items are the Covidien Dover MIDSTREAM KIT CASTILE SOAP, Item Code 2090SA. These towelettes are used to clean the genital area for male and female patients. The recall covers 18,000 kits distributed nationwide in the United States and to Canada.

The affected lot codes are 512590564X, 516087864X, 517488664X, 518889264X, 520288264x, and 521689164X. Consumers and healthcare facilities should stop using these products and contact the manufacturer for further instructions.

The recalled product

Product
Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap towelettes are used to clean the genital area for male and female patients
Manufacturer
Covidien LLC
Affected units
18,000

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.

See all 34 products in this recall →