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Lower risk Medical device recall · FDA · Published November 16, 2020

Galt Medical Centeze Catheter Recall: Incorrect Tip Geometry Risk

Galt Medical recalls specific Centeze catheter models due to incorrect tip geometry causing potential blockage. Affected units include certain lot numbers and catalog codes from 2010-2023.

🇺🇸 FDA recall #Z-0568-2021Medical deviceGalt Medical ›
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Recalling firmGalt Medical Corporation2220 Merritt Dr · Garland, TX 75041-6137
✎ GovInfoNow plain-language explainer

What happened, in plain English

Galt Medical is recalling specific Centeze catheter models because the catheter tip has a thicker wall and more obtuse angle than intended. This could lead to blockages during medical procedures, which may cause complications for patients needing the catheter. Read more at govinfonow.com/recall/63908-galt-medical-centeze-catheter-recall-incorrect-tip-geometry-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63908-galt-medical-centeze-catheter-recall-incorrect-tip-geometry-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0568-2021

Cite this page

“Galt Medical Centeze Catheter Recall: Incorrect Tip Geometry Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63908-galt-medical-centeze-catheter-recall-incorrect-tip-geometry-risk. Based on FDA recall #Z-0568-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0568-2021%22&limit=1).

Why it’s dangerous

The catheter tip has a thicker wall and more obtuse angle than designed, which could cause blockages during medical procedures. This might lead to complications for patients who need the catheter for treatments like draining fluid from the body.

Who’s affected

Patients using the recalled catheter models for medical procedures are most at risk. Healthcare providers who use these specific models for treatments may also be affected.

How to tell if you have this one

Check for the catalog number DRC-002-06 or DRC-006-16 on the catheter packaging. Affected units include specific lot numbers with UDI codes starting with 20108509, 20139676, 20148911, 20160253, or 20189100.

  • Brand
    Galt Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the catalog number DRC-002-06 or DRC-006-16 on the catheter packaging.

Where it went and when

Where it was distributed

Distributed in 8 states and Puerto Rico, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: not listedCTCalifornia: not listedCAUtah: yesUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: not listedTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “U.S.: FL, GA, MA, NC, NJ, OH, PA, Puerto Rico and UT. O.U.S: Canada, Netherlands, Turkey, United Kingdom, and UAE” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Georgia, Massachusetts, New Jersey, North Carolina, Ohio, Pennsylvania, Puerto Rico, Utah.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Nov 16, 202012. FDA classified it Class II: Dec 14, 202023. Published in FDA’s Enforcement Report: Dec 23, 202034. FDA terminated the recall: Nov 7, 2022420202022
  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-0568-2021 (November 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0568-2021 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