Bard Medical Recalls SureStep Foley Tray System Due to Leakage Risk
Bard Medical Division is recalling SureStep Foley Tray Systems because urine may leak around the vent on the vented sample port.
What this means for you
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. The hazard involves a potential leak in a medical device, which is a moderate risk but does not meet the criteria for severe injury or death.
Plain-English summary
Bard Medical Division is recalling the SureStep(TM) FOLEY TRAY SYSTEM, a preconnected closed system foley tray. The recall involves 883,171 units distributed in the US, Canada, and the UAE.
The recall was initiated due to a potential for urine leakage around the vent on the vented sample port. This defect could compromise the integrity of the closed system.
Healthcare facilities and consumers should stop using the affected product codes and lot numbers listed in the official recall notice. Users should contact Bard Medical Division for instructions on returning or replacing the devices.
The recalled product
- Product
- SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A30491
- Manufacturer
- Bard Medical Division
- Hazard
- Affected units
- 883,171
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 (20)
- Product Code
- Lot Numbers A119214M
- Lot numbers: NGCV3931
- NGCV0249 A119216M
- Lot numbers: NGCU1498
- NGCT3665
- NGCU3726
- NGCV0228
- NGCV1406
- NGCS2897
- NGCV2240
- NGCV3113
- NGCV4031
- NGCV3929
- NGCW2317
- NGCW1354 A119218M
- Lot numbers: NGCW0723 A119416M
- Lot numbers: NGCT2589
- NGCT3587
- NGCT4393
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Bard Medical Division
See all →- ModerateBard Medical Recalls ArcticGel Pads Due to Adhesion Defects
FDA (Devices) · 2019-05-08
- ModerateBard SureStep Foley Tray System Recalled for Potential Sample Port Leaks
FDA (Devices) · 2019-02-13
- ModerateBard Midstream Urine Collector Recalled for Iodine Prep Pad Deficiency
FDA (Devices) · 2018-09-05
- HighBard Medical Recalls Arctic Sun Temperature Management Systems Due to Wiring Defect
FDA (Devices) · 2018-08-01
Same hazard · leakage
See all →- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereABIOMED Introducer Kit 23 Fr heart pump accessory leakage risk
FDA (Devices) · 2026-07-22