The Recall Desk
HighFDA (Devices)·Z-1198-2016·Announced 2016-03-30

Castile Soap Towelettes Recalled Due to Bacterial Contamination

FDA is recalling specific lots of Castile soap towelettes used in medical 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 high-risk pathogen (bacteria) in a medical device without reported illness, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling specific lots of Castile soap towelettes manufactured by Covidien LLC. These towelettes, identified by Item Code 24035, are used to clean the genital area for male and female patients and are included in Foley Trays and Mid stream specimen kits.

The recall is being issued because the towelettes are contaminated with bacteria. The affected product is distributed nationwide in the United States and to Canada. The specific lot code for the recalled product is 523657764X.

Consumers and healthcare facilities should check their inventory for this specific lot code. If the product is found, it should be removed from use and returned to the supplier or disposed of according to local regulations.

The recalled product

Product
Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP Item Code: 24035 Castile soap towelettes are used to clean the genital area for male and female patients
Manufacturer
Covidien LLC

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: 523657764X

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 →