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Use caution Medical device recall · FDA · Published January 27, 2022

Bard SURESTEP Catheter Tray Recall: Potential Leak Risk

Bard recalls 14Fr SURESTEP intermittent catheter trays with potential leak at catheter-drain bag connection. Affected units have specific serial numbers. Stop using immediately to prevent leaks.

🇺🇸 FDA recall #Z-0666-2022Medical deviceBard ›
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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

Bard is recalling intermittent catheter trays that may leak at the catheter-drain bag connection. This could lead to infections or discomfort for users. Affected units have specific serial numbers. Read more at govinfonow.com/recall/61212-bard-surestep-catheter-tray-recall-potential-leak-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61212-bard-surestep-catheter-tray-recall-potential-leak-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0666-2022

Cite this page

“Bard SURESTEP Catheter Tray Recall: Potential Leak Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61212-bard-surestep-catheter-tray-recall-potential-leak-risk. Based on FDA recall #Z-0666-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0666-2022%22&limit=1).

Why it’s dangerous

The catheter may leak at the connection point to the drain bag, potentially causing infections or discomfort. This leak could occur during normal use without requiring special conditions.

Who’s affected

People using the Bard SURESTEP 14Fr intermittent catheter tray with the described serial numbers are affected. Those with medical conditions requiring catheter use are at higher risk.

How to tell if you have this one

Check for serial numbers starting with NGEWX106, NGEWX143, NGFQ0368, or NGEW9106 followed by specific numbers. The product was sold with the model reference INTS14C.

  • Brand
    Bard
  • Product
    BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.
Recall numberProduct, codes & lotsQuantity
Z-0666-2022BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C; Serial Number/UDI NGEWX106/(01)00801741183232(17) NGEWX143/(01)00801741183232(17) NGFQ0368/(01)00801741183232(17) NGEW9106/(01)00801741183232(17)2120 units
Z-0667-2022BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C; Serial Number/UDI NGEWX117 (01)00801741183249(17) NGEXX133/(01)00801741183249(17) NGEY0842/(01)00801741183249(17) NGEZ1823/(01)00801741183249(17)1620 units
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

    Look for serial numbers starting with NGEWX106, NGEWX143, NGFQ0368, or NGEW9106 followed by specific numbers.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 16 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Colorado, Florida, Georgia, Idaho, Illinois, Louisiana, Maine, Maryland, Minnesota, Nebraska, New Jersey, North Dakota, Ohio, Pennsylvania, South Dakota, Wisconsin.

Recall timeline

FDA terminated this recall 4.4 years after the firm started it.

1. Firm started the recall: Jan 27, 202212. FDA classified it Class II: Feb 24, 202223. Published in FDA’s Enforcement Report: Mar 2, 202234. FDA terminated the recall: Jul 10, 2026420222026
  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.

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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-0666-2022 (January 27, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0666-2022 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