C.R. Bard Inc recalls SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating,…
Read the official notice →- Date
- 2025-09-24
- Country
- United States
- Brand
- C.R. Bard
- Product
- SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More C.R. Bard recalls
- 2026-09-16
USC.R. Bard Inc recalls Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿…
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
FDA · DeviceC.R. Bard IncWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice →- 2026-05-27
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C.R. Bard Inc recalls Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF:…
Due to stain present on the surface of affected foley catheters.
FDA · DeviceC.R. Bard IncU.S.: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD,…Official notice → - 2025-12-17
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C.R. Bard Inc recalls BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
FDA · DeviceC.R. Bard IncWorldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA,…Official notice → - 2025-09-03
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C.R. Bard Inc recalls Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep…
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney…
FDA · DeviceC.R. Bard IncWorldwide - US Nationwide distribution in the states of IA, PA, AR, OR, MN,…Official notice → - 2025-07-09
- US
C.R. Bard Inc recalls REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
Cather packaging may contain the incorrect French size.
FDA · DeviceC.R. Bard IncWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - 2025-05-28
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C.R. Bard Inc recalls Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
FDA · DeviceC.R. Bard IncUS: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO…Official notice →
Other drugs & medical recalls in the United States
- 2025-10-01
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Glenmark Pharmaceuticals Inc., USA recalls Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited…
CGMP Deviations: Market complaints received for gritty texture (grainy)
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Maquet Cardiovascular, LLC recalls Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate…
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Abbott Point Of Care Inc. recalls i-STAT EG6+ cartridge. List Number: 03P77-25.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
- US
Abbott Point Of Care Inc. recalls i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.