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Lower risk Medical device recall · FDA · Published April 15, 2020

C.R. Bard SureStep Foley Tray System Recall: White Paper Residue Risk

C.R. Bard recalls SureStep Foley Tray System due to potential white paper residue on catheters. Affected units have specific lot numbers and expiration dates. Consumers should contact for details.

🇺🇸 FDA recall #Z-1970-2020Medical deviceC.R. Bard ›
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Contact the company

Recalling firmC.R. Bard Inc8195 Industrial Blvd NE · Covington, GA 30014-1497
✎ GovInfoNow plain-language explainer

What happened, in plain English

C.R. Bard is recalling its SureStep Foley Tray System because it may leave white paper-like residue on catheters. This residue could cause issues during urine drainage procedures, though the exact risk is not specified in the recall. Read more at govinfonow.com/recall/65400-c-r-bard-surestep-foley-tray-system-recall-white-paper.

Source Summary by GovInfoNow · govinfonow.com/recall/65400-c-r-bard-surestep-foley-tray-system-recall-white-paper · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1970-2020

Cite this page

“C.R. Bard SureStep Foley Tray System Recall: White Paper Residue Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65400-c-r-bard-surestep-foley-tray-system-recall-white-paper. Based on FDA recall #Z-1970-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1970-2020%22&limit=1).

Why it’s dangerous

The system may leave a white paper-type residue on catheters during use. This residue could interfere with the catheter's function or cause complications during urine drainage procedures, though the exact risk is not detailed in the recall.

Who’s affected

Patients using the SureStep Foley Tray System for urine drainage, particularly those with catheters that may have residue. Healthcare providers and caregivers are most at risk due to potential contamination.

How to tell if you have this one

Check for the catalog number A304716A, UDI 00801741104299, and lot numbers NGDX4745 through NGDY0568 with specific expiration dates.

  • Brand
    C.R. Bard
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact C.R. Bard

    Reach out to C.R. Bard for specific instructions on how to handle the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 24 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution including in the states of AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MO, NC, NE, NJ, NY, RI, SD, TN, TX, UT, VA, WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, Nebraska, New Jersey, New York, North Carolina, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

1. Firm started the recall: Apr 15, 202012. FDA classified it Class II: May 13, 202023. Published in FDA’s Enforcement Report: May 20, 202034. FDA terminated the recall: May 20, 2021420202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Which lot numbers are affected?

Lot numbers NGDX4745 (Exp. 03/20/2021), NGDY0567 (Exp. 03/20/2021), NGDW1548 (Exp. 11/30/2021), NGDW0234 (Exp. 11/30/2021), NGDX4088 (Exp. 11/30/2021), NGDX4704 (Exp. 11/30/2021), and NGDY0568 (Exp. 11/30/2021).

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1970-2020 (April 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1970-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA