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Use caution Medical device recall · FDA · Published September 1, 2020

Medline ClearPro Suction Catheter Recall: Risk of Breaking During Use

Medline recalls ClearPro Closed Suction Catheter Model DYNCPDS14T due to reports of it breaking during use, which could cause injury. Affected units were sold in specific lots.

🇺🇸 FDA recall #Z-0058-2021Medical deviceMedline ›
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Recalling firmMedline Industries Inc3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

Medline is recalling ClearPro Closed Suction Catheter Model DYNCPDS14T because it has been reported to break during use. This could lead to injury if the catheter disintegrates while being used on patients. Read more at govinfonow.com/recall/64385-medline-clearpro-suction-catheter-recall-risk-of-breaking-during-use.

Source Summary by GovInfoNow · govinfonow.com/recall/64385-medline-clearpro-suction-catheter-recall-risk-of-breaking-during-use · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0058-2021

Cite this page

“Medline ClearPro Suction Catheter Recall: Risk of Breaking During Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64385-medline-clearpro-suction-catheter-recall-risk-of-breaking-during-use. Based on FDA recall #Z-0058-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0058-2021%22&limit=1).

The FDA announced on Sept. 1, 2020, that Medline Industries Inc voluntarily recalled ClearPro Closed Suction Catheters due to reports of the catheter separating from the device assembly during use. The recall affects Model DYNCPDS14T units distributed to 62 U.S. consignees.

How to tell if you have it

  • Brand: Medline
  • Product: ClearPro Closed Suction Catheter, 14 Fr FOR ENDOTRACHEAL TUBE
  • Model: DYNCPDS14T
  • Lots: 06919010016 and 06919020016
  • Quantity: 6,225 units

The hazard

According to the FDA, there have been reports of the suction catheter coming apart from the device assembly during use. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Medline Industries Inc has 48 other recalls on file since Sept. 25, 2015. Other recent recalls of similar products include the Medline Urethral Catheter Tray Recall (May 4, 2026), the Medline Intermittent Latex Catheter Recall (May 4, 2026), and the Medline Medical Procedure Kits Recall (May 4, 2026).

How to tell if you have this one

Check for the model number DYNCPDS14T on the catheter. Affected units were sold in specific lots: 06919010016 and 06919020016.

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

What to do — step by step

  1. Check Product Lot Number

    Look for the lot numbers 06919010016 or 06919020016 on the catheter packaging or label.

How this recall unfolded

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Sep 1, 202012. FDA classified it Class II: Oct 6, 202023. Published in FDA’s Enforcement Report: Oct 14, 202034. FDA terminated the recall: May 27, 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.

✎ GovInfoNow

Questions people ask

Is this catheter safe to use?

The recall states there have been reports of the catheter breaking during use, so it is not safe to use until the recall is addressed.

Can I continue using this catheter?

The recall indicates the catheter has been reported to break during use, so it is not recommended to continue using it without addressing the recall.

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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-0058-2021 (September 1, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0058-2021 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