Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits
FDA is recalling 10,000 units of Aplicare Castile Soap towelettes found in medical kits due to bacterial contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 context without reported illnesses, fitting 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 10,000 units of Aplicare Castile Soap towelettes, Item Code 8000SA, manufactured by Covidien LLC. These towelettes 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 was initiated because the towelettes are contaminated with bacteria. The affected products are identified by Lot Codes 510450164X and 524350264X. The products were distributed nationwide in the United States and to Canada.
Consumers and healthcare facilities should stop using these specific towelettes and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 10,000
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: 510450164X 524350264X
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 →Related recalls
Same manufacturer · Covidien LLC
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
Same hazard · bacterial contamination
See all →- HighClorox Recalls Scented Mistolin and Lestoil Cleaners in Puerto Rico
CPSC · 2026-09-03
- HighCurry chicken salad flagged for possible Listeria contamination in two states
USDA FSIS · 2026-07-30
- ModerateMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- SevereSurgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads
FDA (Devices) · 2026-07-08
Similar recalls
- HighFDA Recalls Dover Foley Catheters Due to Temperature Sensor Failures
FDA (Devices) · 2020-05-20
- SevereCustomed Recalls O.R. Towels Due to Sterility Compromise
FDA (Devices) · 2014-12-10
- SevereCustomed Foley Catheter Kit Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10
- HighRecall of Sterile Wound Dressings Due to Compromised Sterility Barrier
FDA (Devices) · 2017-04-12
- HighRecall of Dover Foley Catheters Due to Temperature Sensor Inaccuracy
FDA (Devices) · 2020-05-20
- SevereCustomed Foley Catheter Kit Recalled for Compromised Sterility
FDA (Devices) · 2014-12-10