The Recall Desk
HighFDA (Devices)·Z-1227-2016·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 risk-of-harm product (bacterial contamination) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Aplicare Castile Soap towelettes that are included in Foley Trays and Mid stream specimen kits. The recall was initiated because the towelettes are contaminated with bacteria.

The affected product is manufactured by Covidien LLC and is used to clean the genital area for male and female patients. The recall covers 9,200 units distributed nationwide in the United States and to Canada. Specific lot codes for the affected items are 512550564X, 513256764X, 515358564X, and 522551364X.

Consumers and healthcare facilities should stop using the affected towelettes and contact the manufacturer or their supplier for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap towelettes are used to clean the genital area for male and female patients
Manufacturer
Covidien LLC
Affected units
9,200

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: 512550564X 513256764X 515358564X 522551364X

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 →