RecallRadar
FDA · Medical devicesClass I

AVID Medical, Inc. medical device recall: Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
98686
Recall initiated
Mar 13, 2026
Classified by FDA
May 1, 2026
Posted in Enforcement Report
May 13, 2026
Recalling firm
AVID Medical, Inc.
Firm location
Toano, VA, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
E-Mail
Products in this event
10

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Mar 13, 2026. FDA classified it 49 days later, on May 1, 2026. This recall event covers 10 separate products, each with its own FDA recall number. Distribution reported by FDA: US distribution to FL, IL, MO, MS, NC, NE, TX. AVID Medical, Inc. has 28 recalls in our records.

Recalled products (10)

  • Z-1970-2026 Class I Ongoing

    Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.

    Codes / lots: 1. Model Number: EAMC1000-05. UDI-DI (Kit Lot Numbers): 10809160377314 (1573593, 1583827, 1609541, 1609725, 1612134, 1612516, 1619132, 1623384, 1627013, 1635459, 1672306, 1675159). 2. Model Number: WAFB208-02. UDI-DI (Kit Lot Numbers): 10809160424759 (1615954, 1653009).

    Quantity: 222 kits

  • Z-1971-2026 Class I Ongoing

    Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.

    Codes / lots: Model Number: DRCC36. UDI-DI (Kit Lot Numbers): 10809160469088 (1659651).

    Quantity: 180 kits

  • Z-1972-2026 Class I Ongoing

    Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.

    Codes / lots: 1. Model Number: SHND401-04. UDI-DI (Kit Lot Numbers): 10809160395615 (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). 2. Model Number: SHND401-05. UDI-DI (Kit Lot Numbers): 10809160491294 (1652367, 1668844, 1668845, 1668846, 1669188, 1669189, 1669504, 1669506, 1669507, 1671312, 1671313, 1671314, 1671315, 1671316).

    Quantity: 6,956 kits

  • Z-1973-2026 Class I Ongoing

    Halyard CATH LAB kit. Model Number: SACL75AM.

    Codes / lots: Model Number: SACL75AM. UDI-DI (Kit Lot Numbers): 10809160413586 (1599684, 1601393).

    Quantity: 228 kits

  • Z-1974-2026 Class I Ongoing

    Halyard CATH LAB kit. Model Number: SACL75-01.

    Codes / lots: Model Number: SACL75-01. UDI (Kit Lot Numbers): (01)20809160481377(17)280520(10)341730(30)004(241)UINR44-01 (341730), (01)20809160481377(17)280623(10)341742(30)004(241)SACL75-01 (341742), (01)20809160481377(17)280609(10)345855(30)004(241)SACL75-01 (345855), (01)20809160481377(17)280609(10)345863(30)004(241)SACL75-01 (345863).

    Quantity: 172 kits

  • Z-1975-2026 Class I Ongoing

    Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.

    Codes / lots: Model Number: SELF131-05. UDI-DI (Kit Lot Numbers): 10809160408650 (1611688, 1611689, 1618351, 1621441, 1627930, 1635908, 1644501, 1646021, 1651957, 1654887, 1656582, 1656581, 1659713, 1670884, 1670885, 1671950).

    Quantity: 2,932 kits

  • Z-1976-2026 Class I Ongoing

    Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.

    Codes / lots: Model Number: UINR44-01. UDI (Kit Lot Number): (01)20809160484439(17)280201(10)340135(30)004(241)UINR44-01 (340135), (01)20809160484439(17)280201(10)340136(30)004(241)UINR44-01 (340136), (01)20809160454439(17)280201(10)340352(30)004(241)UINR44-01 (340352), (01)20809160484439(17)280201(10)349076(30)004(241)UINR44-01 (349076).

    Quantity: 204 kits

  • Z-1977-2026 Class I Ongoing

    Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.

    Codes / lots: 1. Model Number: SLPC34-01. UDI-DI (Kit Lot Numbers): 10809160450963 (1640169, 1641409, 1641410, 1641411, 1641412, 1641413, 1641414, 1641415, 1645684); 10809160459904 (1649576, 1660882, 1660883, 1660884, 1663896, 1665768). 2. Model Number: SLPC34-02. UDI-DI (Kit Lot Numbers): DHR 108916049515 NAV 10809160511213 (1668809, 1668810, 1668812, 1668813, 1668814, 1668815, 1668816).

    Quantity: 6,052 kits

  • Z-1978-2026 Class I Ongoing

    Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.

    Codes / lots: Model Number: SAMM066-15. UDI-DI (Kit Lot Numbers): 10809160388495 (1561685, 1575926, 1583048, 1584017, 1589652, 1595715, 1599634, 1605749, 1611810, 1621476, 1637222, 1637224, 1637225, 1643118, 1645143, 1645637, 1663929, 1663930, 1663931, 1663932).

    Quantity: 2,392 kits

  • Z-1979-2026 Class I Ongoing

    Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.

    Codes / lots: Model Number: VMCD029. UDI-DI (Kit Lot Numbers): 10809160388969 (1601753, 1601754, 1621560).

    Quantity: 75 kits

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 98686
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.

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