Exact FDA event identifier

Event 98686

10 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 13, 2026
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: AVID Medical, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

10 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 10

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

Z-1970-2026

Recall number: Z-1970-2026
Initiated: March 13, 2026
Classification: Class I
Status: Ongoing
Recalling firm: AVID Medical, Inc.
Quantity: 222 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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).

Distribution pattern

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

device · product 2 of 10

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

Z-1971-2026

Recall number: Z-1971-2026
Initiated: March 13, 2026
Classification: Class I
Status: Ongoing
Recalling firm: AVID Medical, Inc.
Quantity: 180 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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

device · product 3 of 10

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

Z-1972-2026

Recall number: Z-1972-2026
Initiated: March 13, 2026
Classification: Class I
Status: Ongoing
Recalling firm: AVID Medical, Inc.
Quantity: 6,956 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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).

Distribution pattern

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

device · product 4 of 10

Halyard CATH LAB kit. Model Number: SACL75AM.

Z-1973-2026

Recall number: Z-1973-2026
Initiated: March 13, 2026
Classification: Class I
Status: Ongoing
Recalling firm: AVID Medical, Inc.
Quantity: 228 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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

device · product 5 of 10

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

Z-1974-2026

Recall number: Z-1974-2026
Initiated: March 13, 2026
Classification: Class I
Status: Ongoing
Recalling firm: AVID Medical, Inc.
Quantity: 172 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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).

Distribution pattern

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

device · product 6 of 10

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

Z-1975-2026

Recall number: Z-1975-2026
Initiated: March 13, 2026
Classification: Class I
Status: Ongoing
Recalling firm: AVID Medical, Inc.
Quantity: 2,932 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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).

Distribution pattern

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

device · product 7 of 10

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

Z-1976-2026

Recall number: Z-1976-2026
Initiated: March 13, 2026
Classification: Class I
Status: Ongoing
Recalling firm: AVID Medical, Inc.
Quantity: 204 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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).

Distribution pattern

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

device · product 8 of 10

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

Z-1977-2026

Recall number: Z-1977-2026
Initiated: March 13, 2026
Classification: Class I
Status: Ongoing
Recalling firm: AVID Medical, Inc.
Quantity: 6,052 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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).

Distribution pattern

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

device · product 9 of 10

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

Z-1978-2026

Recall number: Z-1978-2026
Initiated: March 13, 2026
Classification: Class I
Status: Ongoing
Recalling firm: AVID Medical, Inc.
Quantity: 2,392 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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).

Distribution pattern

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

device · product 10 of 10

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

Z-1979-2026

Recall number: Z-1979-2026
Initiated: March 13, 2026
Classification: Class I
Status: Ongoing
Recalling firm: AVID Medical, Inc.
Quantity: 75 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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