The Recall Desk
HighFDA (Devices)·Z-1200-2016·Announced 2016-03-30

Castile Soap Towelettes Recalled Due to Bacterial Contamination

FDA is recalling 118,400 kits of Castile soap towelettes due to bacterial contamination. The products are used to clean the genital area.

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 any specific illnesses or injuries, fitting the criteria for a High severity rating.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 118,400 kits of Castile soap towelettes manufactured by Covidien LLC. The affected products are included in Foley Trays and Midstream specimen kits and are used to clean the genital area for male and female patients.

The recall was initiated because the Aplicare Castile Soap towelettes are contaminated with bacteria. The specific type of bacteria is not identified in the source text.

The affected products were distributed nationwide in the United States and to Canada. The following lot codes are included in the recall: 518151164X, 519450564X, 520850264X, 521250764X, 522951064X, 525150364X, and 525251064X. 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: 2040SA Castile soap towelettes are used to clean the genital area for male and female patients
Manufacturer
Covidien LLC
Affected units
118,400

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 →