SureStep Foley Tray System Add-A-Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one SureStep Foley Tray System Add-A-Foley Catheter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of SureStep Foley Tray System Add-A-Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Apr 9, 2020 and Apr 9, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
SureStep Foley Tray System Add-A-Foley Catheter recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 25, 2026Class IIOpen, Classified
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Z-3118-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported SureStep Foley Tray System Add-A-Foley Catheter problems
Device problems
- Component Missing1
Patient problems
- No Known Impact Or Consequence To Patient1
SureStep Foley Tray System Add-A-Foley Catheter models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SureStep™ Foley Tray System Add-A-Foley Catheter A399400COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall1 report
- SureStep™ Foley Tray System Add-A-Foley Catheter A153200COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall0 reports
Recent SureStep Foley Tray System Add-A-Foley Catheter adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2020Component Missing
IT WAS REPORTED THAT THE WATER SYRINGE WAS MISSING FROM THE TRAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9945806 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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