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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

Halyard and Cardiac Cath Kits Recalled for Syringe Disconnection Risk

Agency Publication Date: May 1, 2026
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Summary

AVID Medical, Inc. is recalling 19,413 Halyard Cardiac Cath, Cath Lab, and Angiography kits because the rotating adaptor on the Medline syringe within these kits may unwind during use. This defect can lead to a loose or complete disconnection between the syringe and the manifold during medical procedures. These kits were distributed to healthcare facilities in Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, and Texas.

Risk

If the syringe adaptor disconnects, it may cause leaks or air to enter the system, potentially resulting in procedural delays or serious complications during cardiac and vascular imaging.

What You Should Do

  1. Identify if your facility has any of the affected Halyard kits by checking the model and lot numbers on the outer packaging. Affected models include EAMC1000-05, WAFB208-02, DRCC36, SHND401-04, SHND401-05, SACL75AM, SACL75-01, SELF131-05, UINR44-01, SLPC34-01, SLPC34-02, SAMM066-15, and VMCD029.
  2. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product.
  4. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device recalls.

Your Remedy Options

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

Affected Products

Product: Halyard CARDIAC CATH PACK kit
Model / REF:
EAMC1000-05
WAFB208-02
Lot Numbers:
1573593
1583827
1609541
1609725
1612134
1612516
1619132
1623384
1627013
1635459
1672306
1675159
1615954
1653009
UDI:
10809160377314
10809160424759

Contains Medline syringe rotating adaptor.

Product: Halyard CARDIAC CATH PACK SAN23CARDQ kit
Model / REF:
DRCC36
Lot Numbers:
1659651
UDI:
10809160469088
Product: Halyard CARDIAC CATH TRAY SHANDS JAX kit
Model / REF:
SHND401-04
SHND401-05
Lot Numbers:
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
1652367
1668844
1668845
1668846
1669188
1669189
1669504
1669506
1669507
1671312
1671313
1671314
1671315
1671316
UDI:
10809160395615
10809160491294
Product: Halyard CATH LAB kit (SACL75AM)
Model / REF:
SACL75AM
Lot Numbers:
1599684
1601393
UDI:
10809160413586
Product: Halyard CATH LAB kit (SACL75-01)
Model / REF:
SACL75-01
Lot Numbers:
341730
341742
345855
345863
UDI:
20809160481377
Product: Halyard HEART CATH, SELF REGIONAL kit
Model / REF:
SELF131-05
Lot Numbers:
1611688
1611689
1618351
1621441
1627930
1635908
1644501
1646021
1651957
1654887
1656582
1656581
1659713
1670884
1670885
1671950
UDI:
10809160408650
Product: Halyard NEURO IR PERIPHERAL (PS 64405) kit
Model / REF:
UINR44-01
Lot Numbers:
340135
340136
340352
349076
UDI:
20809160484439
20809160454439
Product: Halyard PERC TRAY kit
Model / REF:
SLPC34-01
SLPC34-02
Lot Numbers:
1640169
1641409
1641410
1641411
1641412
1641413
1641414
1641415
1645684
1649576
1660882
1660883
1660884
1663896
1665768
1668809
1668810
1668812
1668813
1668814
1668815
1668816
UDI:
10809160450963
10809160459904
10809160511213
Product: Halyard SAMMC ANGIOGRAPHY kit
Model / REF:
SAMM066-15
Lot Numbers:
1561685
1575926
1583048
1584017
1589652
1595715
1599634
1605749
1611810
1621476
1637222
1637224
1637225
1643118
1645143
1645637
1663929
1663930
1663931
1663932
UDI:
10809160388495
Product: Halyard VA DETROIT CATH LAB PACK kit
Model / REF:
VMCD029
Lot Numbers:
1601753
1601754
1621560
UDI:
10809160388969

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98686
Status: Active
Manufacturer: AVID Medical, Inc.
Sold By: Hospitals; Surgical Centers; Cardiac Catheterization Labs
Manufactured In: United States
Units Affected: 19,413
Distributed To: Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, Texas

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.