C.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination
C.R. Bard Inc is recalling specific Foley and Intermittent Catheter Trays because complaints indicated contamination on the surface of the included Pericare wipes.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or specific high-risk pathogens, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
C.R. Bard Inc is recalling specific lots of Bard Foley Trays, Lubri-Sil I.C. Complete Care All-Silicone Foley Catheter Trays, and SureStep Foley Tray Systems. The recall affects 283,883 trays and kits that were distributed nationwide in the United States and in several international countries, including Canada, Mexico, and the United Arab Emirates.
The recall was initiated due to complaints received indicating the presence of contamination on the surface of the Pericare wipes provided with these catheter trays. The source text does not specify the type of contamination or report any illnesses or injuries associated with the use of these products.
Healthcare facilities and consumers should stop using the affected products and check their inventory against the specific catalog numbers and lot numbers listed in the official recall notice. Users should contact C.R. Bard Inc for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 10801741024921 00801741024931¿ 10801741024938 00801741024948¿ 10801741024945 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone…
- Manufacturer
- C.R. Bard Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 283,883
Distribution
Related recalls
Same manufacturer · C.R. Bard Inc
See all →- HighC.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- HighC.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- ModerateC.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- HighC.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- HighC.R. Bard Recalls SureStep Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
Same hazard · contamination
See all →- SevereGreiner VACUETTE Blood Collection Tubes Recalled for EDTA Contamination
FDA (Devices) · 2026-10-28
- SevereFDA Recalls Argatroban Injection Vials Due to Particulate Matter
FDA (Drugs) · 2026-10-28
- SevereAVID Medical Recalls Halyard Anterior Hip Packs Due to Sterilization Error
FDA (Devices) · 2026-10-28
- SevereEthicon Recalls Silk Surgical Sutures Packaged with Alcohol-Based Fluid
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
Similar recalls
- ModerateC.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- HighC.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- HighC.R. Bard Recalls SureStep Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- HighC.R. Bard Foley Catheter Trays Recalled for Sterile Packaging Defects
FDA (Devices) · 2021-09-29
- HighC.R. Bard Foley Catheter Tray Recalled for Packaging Defects
FDA (Devices) · 2021-09-29
- HighC.R. Bard SureStep Foley Catheter Tray Recalled for Sterile Barrier Defect
FDA (Devices) · 2021-09-29