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FDA recall, , High risk

Medline ReNewal Reprocessed Diagnostic Catheters

Reprocessed catheters may contain small particles of residual material.

Summary by Recall Canary from the FDA notice

What happened

Medline Industries, LP of Northfield, Illinois, began a recall on December 22, 2025, of multiple reprocessed catheter products, including Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters, Reprocessed Biosense Webster Soundstar eco Diagnostic Ultrasound Catheters, Reprocessed Abbott Inquiry Steerable Diagnostic Catheters, Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters, Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters, Reprocessed Siemens Acuson AcuNav Diagnostic Ultrasound Catheters, and Medline ReNewal Reprocessed Webster CS Catheters.

The FDA added the recall to its Enforcement Report on February 6, 2026, and classified it the same day. These lots may contain small particles of residual material, which could cause inflammatory response, systemic infection, granulomatous reaction, or thrombus reaction leading to cerebral or pulmonary embolism or deep vein thrombosis. The products were distributed nationwide.

More foreign object recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

7 products

Affected if its UDI-DI and lot code are listed under that product.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters

    UDI-DI
    • 20197344019554
    • 10197344019557
    Lot code
    • EP250324
    • EP250416
    • EP250512
    • EP250521
    • EP250609
    • EP250630
    • EP250710
    • EP250724

  2. Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters

    UDI-DI
    • 20888277407517
    • 10888277407510
    • 10888277407480
    • 20888277407609
    • 10888277407602
    • 20888277407524
    • 10888277407527
    • 20888277407678
    • 10888277407671
    • 10888277407572
    Lot code
    • EP250618
    • EP250630
    • 401940RH
    • 401904RH
    • 401914RH
    • 401932RH
    • 401652RH

  3. Reprocessed Biosense Webster Soundstar eco Diagnostic Ultrasound Catheters

    UDI-DI
    • 10197344157297
    • 10197344157303
    • 10197344157273
    • 20197344157287
    • 10197344157280
    Lot code
    • EP250724
    • EP250808
    • 10439236RH
    • 10438577RH
    • 10439011RH

  4. Reprocessed Abbott Inquiry Steerable Diagnostic Catheters

    UDI-DI
    • 10197344133253
    • 10197344133284
    • 10197344133307
    • 10197344133444
    • 20197344133236
    • 10197344133239
    • 10197344133246
    • 10197344133291
    • 10197344133512
    • 10197344133529
    • 10197344133260
    • 10197344133352
    • 10197344133376
    • 10197344133383
    • 10197344133437
    • 10197344133420
    Lot code
    • EP250618
    • 81172RH
    • 81202RH
    • 81483RH
    • 81102RH
    • 81104RH
    • 81174RH
    • 81531RH
    • 81532RH
    • 81107RH
    • 81402RH
    • 81404RH
    • 81405RH
    • 81474RH
    • 81473RH

  5. Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters

    UDI-DI
    • 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
    Lot code
    • EP250317
    • 401222RH
    • 401223RH
    • 401226RH
    • EP250307
    • 401227RH
    • 401260RH
    • 401261RH
    • 401306RH
    • 401309RH
    • 401312RH
    • 401430RH
    • 401433RH
    • 401435RH
    • 401441RH
    • 401442RH
    • 401443RH
    • 401448RH
    • 401449RH
    • 401450RH
    • 401451RH
    • 401860RH
    • 401877RH
    • 401878RH
    • 401890RH
    • 401891RH
    • 401994RH
    • 402012RH
    • 402004RH
    • 402010RH
    • 402008RH
    • 402009RH
    • EP250203

  6. Reprocessed Siemens Acuson AcuNav Diagnostic Ultrasound Catheters

    UDI-DI
    • 10197344026500
    • 10197344026517
    Lot code
    • EP250324
    • EP250429
    • EP250521
    • EP250609
    • EP250630
    • EP250710
    • EP250905
    • 10135936RH

  7. Medline ReNewal Reprocessed Webster CS Catheters

    UDI-DI
    • 10197344044023
    • 10197344044030
    • 10197344044054
    • 40197344044048
    • 10197344044047
    Lot code
    • EP250429
    • EP250808
    • BD710DF282RRH
    • BD710FJ282RRH
    • BD710FJ282CRH

Recall details

Company began the recall
Sold in

Distribution US nationwide.

Company
Medline Industries, LPNorthfield, Illinois
Recalls that follow it
Medline Reprocessed Electrophysiology and Ultrasound Catheters
Hazard
Foreign object
Risk

High risk

There is a reasonable chance that using it could cause serious health problems or death.

FDA Class I recall · How risk is rated

Event ID
98277
Recall numbers
Z-1319-2026 to Z-1325-2026

All recalls from Medline Industries, LP

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

More from Medline Industries

See all: More from Medline Industries

Summary by Recall Canary, written with AI · summary updated Oct 23, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)