The Recall Desk
HighFDA (Devices)·Z-1197-2016·Announced 2016-03-30

Castile Soap Towelettes Recalled Due to Bacterial Contamination

FDA is recalling Castile soap towelettes used in Foley trays and specimen kits because they are contaminated with bacteria.

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 '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 manufactured by Covidien LLC. These towelettes, which are used to clean the genital area for male and female patients, are included in Foley trays and midstream specimen kits.

The recall was initiated because the towelettes are contaminated with bacteria. The affected product is the Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL, Item Code 24015. The specific lot codes involved are 522959464X and 525757064X. A total of 16,500 units were distributed nationwide in the United States and to Canada.

Healthcare facilities and consumers who have these specific lots should stop using the product and contact the manufacturer or their supplier for instructions on return or disposal.

The recalled product

Product
Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 Castile soap towelettes are used to clean the genital area for male and female patients
Manufacturer
Covidien LLC
Affected units
16,500

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 (1)

  • Lot Codes: 522959464X 525757064X

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 →