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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Medline ReNewal Reprocessed Electrophysiology Catheters Recalled for Particulates

Agency Publication Date: August 28, 2025
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Summary

Medline Industries, LP is recalling 398 units of Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheters. This recall was initiated because specific lots of these catheters may contain small residual particulates. Medline notified customers of this issue via letter on July 14, 2025, to ensure the affected devices are removed from use.

Risk

The presence of residual particulates in a catheter can lead to serious health complications if the particles enter a patient's bloodstream during a procedure. This may cause inflammation, the formation of blood clots, or a blockage in a blood vessel (embolism).

What You Should Do

  1. This recall affects multiple models of Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheters, including model numbers 401150RH, 401206RH, 401207RH, and over 60 others. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled catheters immediately and quarantine any remaining stock.
  3. Contact Medline Industries, LP - Northfield or your medical device distributor to arrange for the return, replacement, or correction of the affected catheters.
  4. If you have questions regarding this recall, contact Medline Industries directly for further instructions.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding medical device safety.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Cathetersby Medline ReNewal
Model / REF (71):
401150RH
401206RH
401207RH
401210RH
401211RH
401212RH
401222RH
401223RH
401226RH
401227RH
401228RH
401260RH
401261RH
401271RH
401305RH
401306RH
401309RH
401310RH
401311RH
401312RH
401317RH
401353RH
401357RH
401381RH
401392RH
401399RH
401400RH
401425RH
401430RH
401433RH
401434RH
401435RH
401436RH
401438RH
401441RH
401442RH
401445RH
401443RH
401444RH
401448RH
401449RH
401450RH
401451RH
401453RH
401466RH
401468RH
401474RH
401475RH
401859RH
401860RH
Lot Numbers:
EP250106
EP241118
UDI:
10197344043736
10197344043712
10197344043705
10197344043699
10197344043682
10197344043668
10197344043651
10197344043637
10197344043613
10197344043569
10197344043545
10197344043521
10197344043491
10197344043484
10197344043477
10197344043460
10197344043453
10197344043439
10197344044245
10197344044252
10197344044269
10197344044283
10197344044290
10197344044306
10197344044313
10197344044320
10197344044351
10197344044382
10197344044399
10197344044405
10197344044436
10197344044443
10197344044450
10197344044467
10197344044498
10197344044566
10197344044573
10197344044597
10197344043835

Firm initiated voluntary recall for reprocessed diagnostic catheters.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97357
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Hospital and clinical supply channels
Manufactured In: United States
Units Affected: 398 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.