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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/Diagnostic Equipment

Medline Reprocessed Catheters Recalled for Potential Residual Material

Agency Publication Date: February 6, 2026
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Summary

Medline Industries, LP is recalling approximately 1,883 reprocessed catheters across multiple brands, including Abbott, Livewire, St. Jude, and Biosense Webster, because they may contain small particles of residual material from previous use. If these catheters are used during medical procedures, the particles could enter the bloodstream, causing serious complications like infections, blood clots, or blockages in the lungs or brain. This recall expansion includes various steerable and diagnostic ultrasound catheters sold nationwide.

Risk

The presence of residual material on these reprocessed medical devices poses a risk of inflammatory response, systemic infection, or the formation of blood clots. These clots can lead to life-threatening conditions such as a cerebral embolism (stroke), pulmonary embolism, or deep vein thrombosis.

What You Should Do

  1. Identify if you have any affected catheters by checking the brand name and product codes on the packaging, including Medline ReNewal, Abbott Inquiry, Livewire, St. Jude Supreme/Response, ViewFlex Xtra, SOUNDSTAR eco, or ACUSON AcuNav.
  2. Check the model numbers, UDI-DI codes, and lot numbers on the device labels. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-INFO-FDA (1-888-463-6332) for additional questions regarding this device recall.

Your Remedy Options

📋Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline ReNewal Reprocessed Webster CS Catheters
Variants: 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer, 10 Electrodes 2-8-2mm Spacing w/ EZ Steer
Model / REF:
BD710DF282CRH
BD710DF282RRH
BD710FJ282RRH
BD710FJ282CRH
Lot Numbers:
EP250429
EP250808
UDI:
10197344044023
10197344044030
10197344044054
40197344044048
10197344044047

Recall #: Z-1319-2026; Quantity: 228

Product: Reprocessed Abbott Inquiry Steerable Diagnostic Catheters
Variants: 10 Elec. 2-5-2mm, 20 Elec. 2-10-2mm, 4 Elec. 5mm, 10 Elec. 5mm, 4 Elec. 2-5-2mm
Model / REF:
81105RH
81172RH
81202RH
81483RH
81102RH
81104RH
81174RH
81531RH
81532RH
81107RH
81402RH
81404RH
81405RH
81474RH
81473RH
Lot Numbers:
EP250618
UDI:
10197344133253
10197344133284
10197344133307
10197344133444
20197344133236
10197344133239
10197344133246
10197344133291
10197344133512
10197344133529
10197344133260
10197344133352
10197344133376
10197344133383
10197344133437
10197344133420

Recall #: Z-1320-2026; Quantity: 311

Product: Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters
Variants: 10 Elec. 2-5-2mm, 20 Elec. 2-10-2mm, 20 Elec. 2-5-2mm, 20 Elec. 2-8-2-60-2-8-2mm, 8 Elec. 2-2-2mm
Model / REF:
401582RH
401940RH
401904RH
401914RH
401932RH
401652RH
Lot Numbers:
EP250618
EP250630
UDI:
20888277407517
10888277407510
10888277407480
20888277407609
10888277407602
20888277407524
10888277407527
20888277407678
10888277407671
10888277407572

Recall #: Z-1321-2026; Quantity: 41

Product: Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters
Variants: 4 Elec. 2-5-2mm, 4 Elec. 5-5-5mm, 4 Elec. 5mm, 6 Elec. 2-5-2mm, 6 Elec. 5-5-5mm
Model / REF:
401211RH
401222RH
401223RH
401226RH
401227RH
401260RH
401261RH
401306RH
401309RH
401312RH
401430RH
401433RH
401435RH
401441RH
401442RH
401443RH
401448RH
401449RH
401450RH
401451RH
401474RH
401860RH
401877RH
401878RH
401890RH
401891RH
401994RH
402012RH
402004RH
402010RH
402008RH
402009RH
Lot Numbers:
EP250317
EP250307
UDI:
10197344043736
10197344043712
10197344043705
10197344043699
10197344043682
10197344043668
10197344043651
10197344043620
10197344043613
10197344043583
10197344043491
10197344043484
10197344043460
10197344043439
10197344044245
10197344044252
10197344044283
10197344044290
10197344044306
10197344044313
10197344044351
10197344044382
10197344044436
10197344044443
10197344044450
10197344044467
10197344044542
10197344043835
10197344044566
10197344044597
10197344044573
10197344044580

Recall #: Z-1322-2026; Quantity: 48

Product: Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters
Variants: 9F x 90cm
Model / REF:
D087031RH
Lot Numbers:
EP250324
EP250416
EP250512
EP250521
EP250609
EP250630
EP250710
EP250724
UDI:
20197344019554
10197344019557

Recall #: Z-1323-2026; Quantity: 650

Product: Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters
Variants: Use on GE Systems, Use on Siemens Systems
Model / REF:
10439072RH
10438577RH
10439011RH
10439236RH
Lot Numbers:
EP250724
EP250808
UDI:
10197344157297
10197344157303
10197344157273
20197344157287
10197344157280

Recall #: Z-1324-2026; Quantity: 94

Product: Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters
Variants: Use on GE Systems, Use on Siemens Systems
Model / REF:
10135910RH
10043342RH
10135936RH
08255790RH
Lot Numbers:
EP250324
EP250429
EP250521
EP250609
EP250630
EP250710
EP250905
UDI:
10197344026500
10197344026517

Recall #: Z-1325-2026; Quantity: 511

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98277
Status: Active
Manufacturer: Medline Industries, LP
Sold By: Hospital supply channels; Medical device distributors
Manufactured In: United States
Units Affected: 7 products (228; 311; 41; 48; 650; 94; 511)
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.

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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 · 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.