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FDA recall, , High risk

AVID Medical Halyard Cardiac Cath and Cath Lab Kits

Halyard cardiac cath packs and kits may have a syringe adaptor that can unwind, causing loose or full disconnection.

Summary by Recall Canary from the FDA notice

What happened

AVID Medical, Inc. of Toano, Virginia is recalling Halyard cardiac cath packs and kits because the Medline syringe rotating adaptor may unwind during use, potentially causing a loose connection or full disconnection between the syringe and manifold. The FDA added the recall to its Enforcement Report on May 1, 2026.

More device defect 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 your kit affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

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

  1. Halyard Cardiac Cath Tray Shands JAX Kit.

    Model
    • SHND401-04
    UDI-DI
    • 10809160395615
    • 10809160491294
    Lot code
    • 1577749
    • 1577750
    • 1590780
    • 1590782
    • 1590783
    • 1590784
    • 1590785
    • 1590833
    • 1591141
    • 1591142
    • 1597561
    • 1600738
    • 1613343
    • 1622356
    • 1631890
    • 1643855
    • 1643856
    • 1643860
    • 1644853
    • 1645163
    • 1647458
    • 1647459
    • 1647460
    • 1650983
    • 1652365
    • 1652366
    • SHND401-05
    • 1652367
    • 1668844
    • 1668845
    • 1668846
    • 1669188
    • 1669189
    • 1669504
    • 1669506
    • 1669507
    • 1671312
    • 1671313
    • 1671314
    • 1671315
    • 1671316

  2. Halyard Cardiac Cath Pack kit.

    1. Model
      • EAMC1000-05
    2. UDI-DI
      • 10809160377314
      • 10809160424759
      Model code
      • EAMC1000-05
      • WAFB208-02.
      Lot code
      • 1573593
      • 1583827
      • 1609541
      • 1609725
      • 1612134
      • 1612516
      • 1619132
      • 1623384
      • 1627013
      • 1635459
      • 1672306
      • 1675159
      • 1615954
      • 1653009

    Some entries omit identifying details. Check the notice to confirm which units are affected.

  3. Halyard Cardiac Cath Pack SAN23CARDQ Kit.

    Model
    • DRCC36
    UDI-DI
    • 10809160469088
    Lot code
    • 1659651

  4. Halyard Cath LAB kit.

    1. Model
      • SACL75AM
    2. Model
      • SACL75-01
    3. UDI-DI
      • 20809160481377
      Model code
      • SACL75-01.
      Lot code
      • 280520
      • 341730
      • 004
      • 241
      • UINR44-01
      • 280623
      • 341742
      • 280609
      • 345855
      • 345863
    4. UDI-DI
      • 10809160413586
      Model code
      • SACL75AM.
      Lot code
      • 1599684
      • 1601393

    Some entries omit identifying details. Check the notice to confirm which units are affected.

  5. Halyard Heart Cath, Self Regional Kit.

    Model
    • SELF131-05
    UDI-DI
    • 10809160408650
    Lot code
    • 1611688
    • 1611689
    • 1618351
    • 1621441
    • 1627930
    • 1635908
    • 1644501
    • 1646021
    • 1651957
    • 1654887
    • 1656582
    • 1656581
    • 1659713
    • 1670884
    • 1670885
    • 1671950

  6. Halyard Neuro IR Peripheral (PS 64405) kit.

    Model
    • UINR44-01
    UDI-DI
    • 20809160484439
    • 20809160454439
    Lot code
    • 280201
    • 340135
    • 004
    • 241
    • 340136
    • 340352
    • 349076

  7. Halyard VA Detroit Cath LAB Pack Kit.

    UDI-DI
    • 10809160388969
    Model code
    • VMCD029.
    Lot code
    • 1601753
    • 1601754
    • 1621560

  8. Halyard Sammc Angiography kit.

    UDI-DI
    • 10809160388495
    Model code
    • SAMM066-15.
    Lot code
    • 1561685
    • 1575926
    • 1583048
    • 1584017
    • 1589652
    • 1595715
    • 1599634
    • 1605749
    • 1611810
    • 1621476
    • 1637222
    • 1637224
    • 1637225
    • 1643118
    • 1645143
    • 1645637
    • 1663929
    • 1663930
    • 1663931
    • 1663932

  9. Halyard Perc Tray kit.

    UDI-DI
    • 10809160450963
    • 10809160459904
    • 108916049515
    • 10809160511213
    Model code
    • SLPC34-01
    • SLPC34-02.
    Lot code
    • 1640169
    • 1641409
    • 1641410
    • 1641411
    • 1641412
    • 1641413
    • 1641414
    • 1641415
    • 1645684
    • 1668809
    • 1668810
    • 1668812
    • 1668813
    • 1668814
    • 1668815
    • 1668816

Recall details

Company began the recall
Sold in
7 states
Company
AVID Medical, Inc.Toano, Virginia
Hazard
Device defect
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
98686
Recall numbers
Z-1970-2026 to Z-1979-2026

All recalls from AVID Medical, Inc.

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. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

Same product, other recalls

Summary by Recall Canary, written with AI · summary updated Oct 25, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)