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Limited official informationFDA Medical Device Enforcement ReportsRecall date: May 13, 2026

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

Full official product description

Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05. | Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36. | Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029. | Halyard CATH LAB kit. Model Number: SACL75-01. | Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02. | Halyard CATH LAB kit. Model Number: SACL75AM. | Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01. | Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05. | Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15. | Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 3, 2026, 7:43 PM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.; Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.; plus 8 additional official variants listed below.

Identifiers to compare

  • Model SHND401-04
  • Model DRCC36
  • Model Numbers
  • Model SACL75-01
  • Model EAMC1000-05
  • Model SACL75AM
  • Model UINR44-01
  • Model SELF131-05
  • Model SHND401-05
  • Model VMCD029
  • Model WAFB208-02
  • Model SAMM066-15
  • Model SLPC34-01
  • Model SLPC34-02
  • Lot Numbers
  • Lot Number
  • Lot 1577750
  • Lot 1590780
  • Lot 1590782
  • Lot 1590783
  • Lot 1590784
  • Lot 1590785
  • Lot 1590833
  • Lot 1591141
  • Lot 1591142
  • Lot 1597561
  • Lot 1668844
  • Lot 1668845
  • Lot 1668846
  • Lot 1669188
  • Lot 1669189
  • Lot 1669504
  • Lot 1669506
  • Lot 1669507
  • Lot 1671312
  • Lot 1671313
  • Lot 1601754
  • Lot 1583827
  • Lot 1609541
  • Lot 1609725
  • Lot 1612134
  • Lot 1612516
  • Lot 1619132
  • Lot 1623384
  • Lot 1627013
  • Lot 1635459
  • Lot 1672306
  • Lot 1611689
  • Lot 1618351
  • Lot 1621441
  • Lot 1627930
  • Lot 1635908
  • Lot 1644501
  • Lot 1646021
  • Lot 1651957
  • Lot 1654887
  • Lot 1656582
  • Lot 1575926
  • Lot 1583048
  • Lot 1584017
  • Lot 1589652
  • Lot 1595715
  • Lot 1599634
  • Lot 1605749
  • Lot 1611810
  • Lot 1621476
  • Lot 1637222
  • Lot 1641409
  • Lot 1641410
  • Lot 1641411
  • Lot 1641412
  • Lot 1641413
  • Lot 1641414
  • Lot 1641415
  • Lot 1668810
  • Lot 1668812
  • Lot 1668813
  • Lot 1668814
  • Lot 1668815

10 official variants

Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.1. 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).6,956 kitsZ-1972-2026
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.Model Number: DRCC36. UDI-DI (Kit Lot Numbers): 10809160469088 (1659651).180 kitsZ-1971-2026
Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.Model Number: VMCD029. UDI-DI (Kit Lot Numbers): 10809160388969 (1601753, 1601754, 1621560).75 kitsZ-1979-2026
Halyard CATH LAB kit. Model Number: SACL75-01.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).172 kitsZ-1974-2026
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.1. 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).222 kitsZ-1970-2026
Halyard CATH LAB kit. Model Number: SACL75AM.Model Number: SACL75AM. UDI-DI (Kit Lot Numbers): 10809160413586 (1599684, 1601393).228 kitsZ-1973-2026
Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.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).204 kitsZ-1976-2026
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.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).2,932 kitsZ-1975-2026
Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.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).2,392 kitsZ-1978-2026
Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.1. 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).6,052 kitsZ-1977-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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.

Agency classification: Class I

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

US distribution to FL, IL, MO, MS, NC, NE, TX.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

  • : affectedSummary changed in the official record.