Fresh Recalls

FDAClass II · Medical device · Recall Z-3044-2026 · Recalled September 9, 2026

Halyard medical convenience kits labeled as recall — AVID Medical, Inc.

Agency report date: September 9, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Halyard medical convenience kits labeled as
Company / brand
AVID Medical
Lot / serial / date codes
Model/Item Number (kit) ACEN89-01, UDI/DI 10809160459447, Kit Lot Number 1650691; Model/Item Number (kit) ACEN89-01, UDI/DI 10809160496411, Kit Lot Number 1675577; Model/Item Number (kit) ACEN89-01, UDI/DI 10809160459447, Kit Lot Number 1666553; Model/Item Number (kit) ACEN89-02, UDI/DI 10809160505304, Kit Lot Number 1683926; Model/Item Number (kit) ACEN89-02, UDI/DI 10809160505304, Kit Lot Number 1683927; Model/Item Number (kit) ALBK51-01, UDI/DI 10809160458587, Kit Lot Number 1649240; Model/Item Number (kit) ALBK51-01, UDI/DI 10809160458587, Kit Lot Number 1649721; Model/Item Number (kit) ALBK51-01, UDI/DI 10809160496374, Kit Lot Number 1675589; Model/Item Number (kit) DGSP71, UDI/DI 10809160468036, Kit Lot Number 1659332; Model/Item Number (kit) DRBS37, UDI/DI 10809160466858, Kit Lot Number 1658530; Model/Item Number (kit) DRBS37-01, UDI/DI 10809160503829, Kit Lot Number 1681363; Model/Item Number (kit) DRBS37-01, UDI/DI 10809160503829, Kit Lot Number 1681470; Model/Item Number (kit) DRBS37-01, UDI/DI 10809160503829, Kit Lot Number 1691461; Model/Item Number (kit) DRNS92, UDI/DI 10809160466346, Kit Lot Number 1658536; Model/Item Number (kit) DRNS92-01, UDI/DI 10809160503942, Kit Lot Number 1681504; Model/Item Number (kit) DRNS92-02, UDI/DI 10809160509463, Kit Lot Number 1696890; Model/Item Number (kit) DRSP26, UDI/DI 10809160466384, Kit Lot Number 1659340; Model/Item Number (kit) DRSP26-01, UDI/DI 10809160505113, Kit Lot Number 1683469; Model/Item Number (kit) DRSP26-02, UDI/DI 10809160509470, Kit Lot Number 1691780; Model/Item Number (kit) DRSP52, UDI/DI 10809160466391, Kit Lot Number 1658538; Model/Item Number (kit) DRSP52-01, UDI/DI 10809160503928, Kit Lot Number 1681522; Model/Item Number (kit) DRSP52-01, UDI/DI 10809160503928, Kit Lot Number 1690963; Model/Item Number (kit) DULY32, UDI/DI 10809160491713, Kit Lot Number 1672111; Model/Item Number (kit) DULY32-01, UDI/DI 10809160506752, Kit Lot Number 1684863; Model/Item Number (kit) DUMF13-01, UDI/DI 10809160498194, Kit Lot Number 1675866; Model/Item Number (kit) DUMF13-02, UDI/DI 10809160513668, Kit Lot Number 1696000; Model/Item Number (kit) DUNS94, UDI/DI 10809160493380, Kit Lot Number 1672112; Model/Item Number (kit) DUNS94-01, UDI/DI 10809160513309, Kit Lot Number 1696906; Model/Item Number (kit) DUPS11-01, UDI/DI 10809160497654, Kit Lot Number 1675527; Model/Item Number (kit) DUPS11-02, UDI/DI 10809160514245, Kit Lot Number 1696671; Model/Item Number (kit) DUTM67-01, UDI/DI 10809160498255, Kit Lot Number 1675954; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1663944; Model/Item Number (kit) DVSP33J, UDI/DI 10809160422601, Kit Lot Number 1630941; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1668872; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1668873; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1663942; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1663941; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1693905; Model/Item Number (kit) EAMC108-03, UDI/DI 10809160308332, Kit Lot Number 1648525; Model/Item Number (kit) EAMC108-03, UDI/DI 10809160308332, Kit Lot Number 1657459; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1647073; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1652746; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1653958; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1663289; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1668701; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1702932; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160442104, Kit Lot Number 1633240; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1646885; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1679527; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1666246; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1666500; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1667490; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1696290; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1697819; Model/Item Number (kit) EUOR004-04, UDI/DI 10809160436172, Kit Lot Number 1627776; Model/Item Number (kit) EUOR004-04, UDI/DI 10809160457252, Kit Lot Number 1668123; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1665330; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1669003; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1671045; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1693989; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1664462; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 374805; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 374807; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 375045; Model/Item Number (kit) JACK401-07, UDI/DI 10809160457122, Kit Lot Number 1647194; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1656191; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1647195; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1664711; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1672072; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1664712; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1656190; Model/Item Number (kit) JACK401-09, UDI/DI 10809160493335, Kit Lot Number 1672074; Model/Item Number (kit) JACK401-09, UDI/DI 10809160493335, Kit Lot Number 1672073; Model/Item Number (kit) JACK401-09, UDI/DI 10809160521922, Kit Lot Number 852288; Model/Item Number (kit) JACK401-09, UDI/DI 10809160521922, Kit Lot Number 852289; Model/Item Number (kit) JACK401-09, UDI/DI 10809160521922, Kit Lot Number 857175; Model/Item Number (kit) JACK401-09, UDI/DI 10809160521922, Kit Lot Number 858450; Model/Item Number (kit) JACK401-09, UDI/DI 10809160521922, Kit Lot Number 863863; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1624320; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1624321; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1632235; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1624322; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1673702; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1664473; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1657644; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1671055; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1662136; Model/Item Number (kit) JEBK01-01, UDI/DI 10809160443132, Kit Lot Number 1634523; Model/Item Number (kit) JEBK01-01, UDI/DI 10809160443132, Kit Lot Number 1634522; Model/Item Number (kit) JEBK01-01, UDI/DI 10809160443132, Kit Lot Number 1643364; Model/Item Number (kit) LBPS18-01, UDI/DI 10809160438169, Kit Lot Number 1630467; Model/Item Number (kit) LBPS18-01, UDI/DI 10809160438169, Kit Lot Number 1630023; Model/Item Number (kit) LBPS18-01, UDI/DI 10809160438169, Kit Lot Number 1639340; Model/Item Number (kit) LBPS18-01, UDI/DI 10809160438169, Kit Lot Number 1658421; Model/Item Number (kit) LBPS18-01, UDI/DI 10809160438169, Kit Lot Number 1666815; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160438183, Kit Lot Number 1639341; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160438183, Kit Lot Number 1629949; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160438183, Kit Lot Number 1635273; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160461396, Kit Lot Number 1652833; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160461396, Kit Lot Number 1652834; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160496459, Kit Lot Number 1676545; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160496459, Kit Lot Number 371520; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160496459, Kit Lot Number 1691995; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160496459, Kit Lot Number 351420; Model/Item Number (kit) MAMC251-09, UDI/DI 10809160504956, Kit Lot Number 1694232; Model/Item Number (kit) NAFB071-10, UDI/DI 10809160466025, Kit Lot Number 1659349; Model/Item Number (kit) NAFB071-10, UDI/DI 10809160466025, Kit Lot Number 1659350; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1666862; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1661830; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1666863; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1669024; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1694083; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1665985; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160522011, Kit Lot Number 1629904; Model/Item Number (kit) SAMM029-17, UDI/DI 10809160439746, Kit Lot Number 1628621; Model/Item Number (kit) SELF112-03, UDI/DI 10809160458761, Kit Lot Number 1669327; Model/Item Number (kit) SELF112-03, UDI/DI 10809160458761, Kit Lot Number 1674472; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1664121; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1622345; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1651571; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1664960; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1669881; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1691644; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1668350; Model/Item Number (kit) SHOR001-15, UDI/DI 10809160390627, Kit Lot Number 1628492; Model/Item Number (kit) SHOR001-15, UDI/DI 10809160390627, Kit Lot Number 1603012; Model/Item Number (kit) SHOR001-15, UDI/DI 10809160390627, Kit Lot Number 1614967; Model/Item Number (kit) SHOR001-15, UDI/DI 10809160390627, Kit Lot Number 1644461; Model/Item Number (kit) SHOR005-12, UDI/DI 10809160390504, Kit Lot Number 1592255; Model/Item Number (kit) SHOR005-12, UDI/DI 10809160390504, Kit Lot Number 1613423; Model/Item Number (kit) SHOR005-12, UDI/DI 10809160390504, Kit Lot Number 1614368; Model/Item Number (kit) SHOR005-12, UDI/DI 10809160390504, Kit Lot Number 1644463; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160440162, Kit Lot Number 1631480; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160440162, Kit Lot Number 1654403; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160488102, Kit Lot Number 1663961; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160440162, Kit Lot Number 1631504; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160488102, Kit Lot Number 1667105; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160488102, Kit Lot Number 1663960; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160488102, Kit Lot Number 1663959; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160488102, Kit Lot Number 1667106; Model/Item Number (kit) SLDP19-01, UDI/DI 10809160487600, Kit Lot Number 1666282; Model/Item Number (kit) SLDP19-01, UDI/DI 10809160487600, Kit Lot Number 1670036; Model/Item Number (kit) SLDP19-01, UDI/DI 10809160450055, Kit Lot Number 1654404; Model/Item Number (kit) SLDP19-01, UDI/DI 10809160487600, Kit Lot Number 1700561; Model/Item Number (kit) SLDP19-01, UDI/DI 10809160487600, Kit Lot Number 1695108; Model/Item Number (kit) SPST001-06, UDI/DI 10809160464809, Kit Lot Number 1656777; Model/Item Number (kit) SPST001-06, UDI/DI 10809160464809, Kit Lot Number 1692410; Model/Item Number (kit) SPST001-06, UDI/DI 10809160464809, Kit Lot Number 1656775; Model/Item Number (kit) SPST001-06, UDI/DI 10809160464809, Kit Lot Number 1656776; Model/Item Number (kit) SWMR011-02, UDI/DI 10809160370872, Kit Lot Number 1659735; Model/Item Number (kit) SWMR011-02, UDI/DI 10809160370872, Kit Lot Number 1666375; Model/Item Number (kit) SWMR011-02, UDI/DI 10809160370872, Kit Lot Number 1673256; Model/Item Number (kit) SWMR011-02, UDI/DI 10809160370872, Kit Lot Number 1673257; Model/Item Number (kit) SWMR011-02, UDI/DI 10809160370872, Kit Lot Number 1680822; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1664508; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1666872; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1668885; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1691142; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1653638; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1666205; Model/Item Number (kit) VALD009-08, UDI/DI 10809160380833, Kit Lot Number 1662413; Model/Item Number (kit) VALD009-08, UDI/DI 10809160380833, Kit Lot Number 1637807; Model/Item Number (kit) VALD009-08, UDI/DI 10809160380833, Kit Lot Number 1645595; Model/Item Number (kit) VALD009-08, UDI/DI 10809160380833, Kit Lot Number 1658681; Model/Item Number (kit) VALD009-08, UDI/DI 10809160380833, Kit Lot Number 1602791; Model/Item Number (kit) VALV225-02, UDI/DI 10809160406250, Kit Lot Number 1629195; Model/Item Number (kit) VAST008-10, UDI/DI 10809160461334, Kit Lot Number 1641263; Model/Item Number (kit) WRNM033-22, UDI/DI 10809160470114, Kit Lot Number 1667341.
Distribution
US Nationwide distribution in the states of AZ, CA, CO, WA, WY, TX, MI, FL, MD, UT, NC, MS, PA, MO, IA, NE, OH, IL, SD, MN, GA.
Agency product description and boundaries

Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit) ACEN89-02; 3) BACK PACK, Model/Item Number (kit) ALBK51-01; 4) DR DERIAN SPINE PACK SNEDHCPDH, Model/Item Number (kit) DGSP71; 5) BASIC PACK DR BROWN SBADHBPR16, Model/Item Number (kit) DRBS37; 6) BASIC PACK DR BROWN SBADHBPR16, Model/Item Number (kit) DRBS37-01; 7) NASAL PACK SEN23SNRC3, Model/Item Number (kit) DRNS92; 8) NASAL PACK SEN23SNRC3, Model/Item Number (kit) DRNS92-01; 9) NASAL PACK SEN23SNRC3, Model/Item Number (kit) DRNS92-02; 10) SPINE PACK DR BROWN SNEDHSPR14, Model/Item Number (kit) DRSP26; 11) SPINE PACK DR BROWN SNEDHSPR14, Model/Item Number (kit) DRSP26-01; 12) SPINE PACK DR BROWN SNEDHSPR14, Model/Item Number (kit) DRSP26-02; 13) SPINE DR HEYS PACK SNE23SSRCT, Model/Item Number (kit) DRSP52; 14) SPINE DR HEYS PACK SNE23SSRCT, Model/Item Number (kit) DRSP52-01; 15) OHN LARYNGOSCOPY PACK SEN23BRD, Model/Item Number (kit) DULY32; 16) OHN LARYNGOSCOPY PACK SEN23BRD, Model/Item Number (kit) DULY32-01; 17) MICRO FLAP PK SEN23EN14T, Model/Item Number (kit) DUMF13-01; 18) MICRO FLAP PK SEN23EN14T, Model/Item Number (kit) DUMF13-02; 19) OHN NASAL PROCEDURE PACK SEN23, Model/Item Number (kit) DUNS94; 20) OHN NASAL PROCEDURE PACK SEN23, Model/Item Number (kit) DUNS94-01; 21) ORTHO POSTERIOR SPINE PK SOP23, Model/Item Number (kit) DUPS11-01; 22) ORTHO POSTERIOR SPINE PK, Model/Item Number (kit) DUPS11-02; 23) TRAM PACK SBA95TPDU6, Model/Item Number (kit) DUTM67-01; 24) SPINE PACK 176537, Model/Item Number (kit) DVSP33J; 25) LAMINECTOMY PACK, Model/Item Number (kit) EAMC108-03; 26) OMFS PACK, Model/Item Number (kit) EAMC124; 27) SINUS PACK 711866, Model/Item Number (kit) EFSN20-01; 28) KIT,SPINE, Model/Item Number (kit) EUOR004-04; 29) SPINE PACK 176556, Model/Item Number (kit) HOSP20I; 30) LAMINECTOMY PACK, Model/Item Number (kit) JACK401-07; 31) LAMINECTOMY PACK, Model/Item Number (kit) JACK401-08; 32) LAMINECTOMY PACK, Model/Item Number (kit) JACK401-09; 33) SPINE PACK 176476, Model/Item Number (kit) JCSP60F; 34) BACK PACK, Model/Item Number (kit) JEBK01-01; 35) PEDS SINUS PACK, Model/Item Number (kit) LBPS18-01; 36) SINUS PACK, Model/Item Number (kit) LBSN49-01; 37) ORAL SURGERY MAJOR PACK, Model/Item Number (kit) MAMC251-09; 38) SPINE PACK, Model/Item Number (kit) NAFB071-10; 39) SPINE PACK 176524, Model/Item Number (kit) OSSP27-01; 40) ORAL SURGERY HEAD, Model/Item Number (kit) SAMM029-17; 41) LAMINECTOMY PACK, Model/Item Number (kit) SELF112-03; 42) CPT FSC SINUS PACK, Model/Item Number (kit) SHAN415-01; 43) DR. DELASOTTA PLIF, Model/Item Number (kit) SHOR001-15; 44) DELASOTTA MINOR BACK, Model/Item Number (kit) SHOR005-12; 45) SPINE PACK, Model/Item Number (kit) SLCR80-01; 46) DIEP PACK, Model/Item Number (kit) SLDP19-01; 47) SPINE PACK - MAJOR, Model/Item Number (kit) SPST001-06; 48) ESS TRAY, Model/Item Number (kit) SWMR011-02; 49) SPINE PACK 176547, Model/Item Number (kit) TPSP14-01; 50) LAMINECTOMY PACK, Model/Item Number (kit) VALD009-08; 51) EENT PACK, Model/Item Number (kit) VALV225-02; 52) NEURO PACK, Model/Item Number (kit) VAST008-10; 53) SPINAL FUSION, Model/Item Number (kit) WRNM033-22.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Halyard medical convenience kits labeled as recall status

3. Open the official notice or contact

Official recall ID
Z-3044-2026
Brand
All AVID Medical recalls
Classification
Class II
Units affected
11763 kits
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Toano, VA, United States
Firm address
9000 Westmont Dr, N/A, 23168-9351

Identifying details (verbatim from the notice)

Product codes / lots
Model/Item Number (kit) ACEN89-01, UDI/DI 10809160459447, Kit Lot Number 1650691; Model/Item Number (kit) ACEN89-01, UDI/DI 10809160496411, Kit Lot Number 1675577; Model/Item Number (kit) ACEN89-01, UDI/DI 10809160459447, Kit Lot Number 1666553; Model/Item Number (kit) ACEN89-02, UDI/DI 10809160505304, Kit Lot Number 1683926; Model/Item Number (kit) ACEN89-02, UDI/DI 10809160505304, Kit Lot Number 1683927; Model/Item Number (kit) ALBK51-01, UDI/DI 10809160458587, Kit Lot Number 1649240; Model/Item Number (kit) ALBK51-01, UDI/DI 10809160458587, Kit Lot Number 1649721; Model/Item Number (kit) ALBK51-01, UDI/DI 10809160496374, Kit Lot Number 1675589; Model/Item Number (kit) DGSP71, UDI/DI 10809160468036, Kit Lot Number 1659332; Model/Item Number (kit) DRBS37, UDI/DI 10809160466858, Kit Lot Number 1658530; Model/Item Number (kit) DRBS37-01, UDI/DI 10809160503829, Kit Lot Number 1681363; Model/Item Number (kit) DRBS37-01, UDI/DI 10809160503829, Kit Lot Number 1681470; Model/Item Number (kit) DRBS37-01, UDI/DI 10809160503829, Kit Lot Number 1691461; Model/Item Number (kit) DRNS92, UDI/DI 10809160466346, Kit Lot Number 1658536; Model/Item Number (kit) DRNS92-01, UDI/DI 10809160503942, Kit Lot Number 1681504; Model/Item Number (kit) DRNS92-02, UDI/DI 10809160509463, Kit Lot Number 1696890; Model/Item Number (kit) DRSP26, UDI/DI 10809160466384, Kit Lot Number 1659340; Model/Item Number (kit) DRSP26-01, UDI/DI 10809160505113, Kit Lot Number 1683469; Model/Item Number (kit) DRSP26-02, UDI/DI 10809160509470, Kit Lot Number 1691780; Model/Item Number (kit) DRSP52, UDI/DI 10809160466391, Kit Lot Number 1658538; Model/Item Number (kit) DRSP52-01, UDI/DI 10809160503928, Kit Lot Number 1681522; Model/Item Number (kit) DRSP52-01, UDI/DI 10809160503928, Kit Lot Number 1690963; Model/Item Number (kit) DULY32, UDI/DI 10809160491713, Kit Lot Number 1672111; Model/Item Number (kit) DULY32-01, UDI/DI 10809160506752, Kit Lot Number 1684863; Model/Item Number (kit) DUMF13-01, UDI/DI 10809160498194, Kit Lot Number 1675866; Model/Item Number (kit) DUMF13-02, UDI/DI 10809160513668, Kit Lot Number 1696000; Model/Item Number (kit) DUNS94, UDI/DI 10809160493380, Kit Lot Number 1672112; Model/Item Number (kit) DUNS94-01, UDI/DI 10809160513309, Kit Lot Number 1696906; Model/Item Number (kit) DUPS11-01, UDI/DI 10809160497654, Kit Lot Number 1675527; Model/Item Number (kit) DUPS11-02, UDI/DI 10809160514245, Kit Lot Number 1696671; Model/Item Number (kit) DUTM67-01, UDI/DI 10809160498255, Kit Lot Number 1675954; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1663944; Model/Item Number (kit) DVSP33J, UDI/DI 10809160422601, Kit Lot Number 1630941; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1668872; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1668873; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1663942; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1663941; Model/Item Number (kit) DVSP33J, UDI/DI 10809160488256, Kit Lot Number 1693905; Model/Item Number (kit) EAMC108-03, UDI/DI 10809160308332, Kit Lot Number 1648525; Model/Item Number (kit) EAMC108-03, UDI/DI 10809160308332, Kit Lot Number 1657459; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1647073; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1652746; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1653958; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1663289; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1668701; Model/Item Number (kit) EAMC124, UDI/DI 10809160404799, Kit Lot Number 1702932; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160442104, Kit Lot Number 1633240; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1646885; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1679527; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1666246; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1666500; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1667490; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1696290; Model/Item Number (kit) EFSN20-01, UDI/DI 10809160456132, Kit Lot Number 1697819; Model/Item Number (kit) EUOR004-04, UDI/DI 10809160436172, Kit Lot Number 1627776; Model/Item Number (kit) EUOR004-04, UDI/DI 10809160457252, Kit Lot Number 1668123; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1665330; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1669003; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1671045; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1693989; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 1664462; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 374805; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 374807; Model/Item Number (kit) HOSP20I, UDI/DI 10809160488133, Kit Lot Number 375045; Model/Item Number (kit) JACK401-07, UDI/DI 10809160457122, Kit Lot Number 1647194; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1656191; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1647195; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1664711; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1672072; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1664712; Model/Item Number (kit) JACK401-08, UDI/DI 10809160465004, Kit Lot Number 1656190; Model/Item Number (kit) JACK401-09, UDI/DI 10809160493335, Kit Lot Number 1672074; Model/Item Number (kit) JACK401-09, UDI/DI 10809160493335, Kit Lot Number 1672073; Model/Item Number (kit) JACK401-09, UDI/DI 10809160521922, Kit Lot Number 852288; Model/Item Number (kit) JACK401-09, UDI/DI 10809160521922, Kit Lot Number 852289; Model/Item Number (kit) JACK401-09, UDI/DI 10809160521922, Kit Lot Number 857175; Model/Item Number (kit) JACK401-09, UDI/DI 10809160521922, Kit Lot Number 858450; Model/Item Number (kit) JACK401-09, UDI/DI 10809160521922, Kit Lot Number 863863; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1624320; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1624321; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1632235; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1624322; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1673702; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1664473; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1657644; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1671055; Model/Item Number (kit) JCSP60F, UDI/DI 10809160423189, Kit Lot Number 1662136; Model/Item Number (kit) JEBK01-01, UDI/DI 10809160443132, Kit Lot Number 1634523; Model/Item Number (kit) JEBK01-01, UDI/DI 10809160443132, Kit Lot Number 1634522; Model/Item Number (kit) JEBK01-01, UDI/DI 10809160443132, Kit Lot Number 1643364; Model/Item Number (kit) LBPS18-01, UDI/DI 10809160438169, Kit Lot Number 1630467; Model/Item Number (kit) LBPS18-01, UDI/DI 10809160438169, Kit Lot Number 1630023; Model/Item Number (kit) LBPS18-01, UDI/DI 10809160438169, Kit Lot Number 1639340; Model/Item Number (kit) LBPS18-01, UDI/DI 10809160438169, Kit Lot Number 1658421; Model/Item Number (kit) LBPS18-01, UDI/DI 10809160438169, Kit Lot Number 1666815; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160438183, Kit Lot Number 1639341; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160438183, Kit Lot Number 1629949; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160438183, Kit Lot Number 1635273; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160461396, Kit Lot Number 1652833; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160461396, Kit Lot Number 1652834; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160496459, Kit Lot Number 1676545; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160496459, Kit Lot Number 371520; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160496459, Kit Lot Number 1691995; Model/Item Number (kit) LBSN49-01, UDI/DI 10809160496459, Kit Lot Number 351420; Model/Item Number (kit) MAMC251-09, UDI/DI 10809160504956, Kit Lot Number 1694232; Model/Item Number (kit) NAFB071-10, UDI/DI 10809160466025, Kit Lot Number 1659349; Model/Item Number (kit) NAFB071-10, UDI/DI 10809160466025, Kit Lot Number 1659350; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1666862; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1661830; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1666863; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1669024; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1694083; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160437391, Kit Lot Number 1665985; Model/Item Number (kit) OSSP27-01, UDI/DI 10809160522011, Kit Lot Number 1629904; Model/Item Number (kit) SAMM029-17, UDI/DI 10809160439746, Kit Lot Number 1628621; Model/Item Number (kit) SELF112-03, UDI/DI 10809160458761, Kit Lot Number 1669327; Model/Item Number (kit) SELF112-03, UDI/DI 10809160458761, Kit Lot Number 1674472; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1664121; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1622345; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1651571; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1664960; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1669881; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1691644; Model/Item Number (kit) SHAN415-01, UDI/DI 10809160426005, Kit Lot Number 1668350; Model/Item Number (kit) SHOR001-15, UDI/DI 10809160390627, Kit Lot Number 1628492; Model/Item Number (kit) SHOR001-15, UDI/DI 10809160390627, Kit Lot Number 1603012; Model/Item Number (kit) SHOR001-15, UDI/DI 10809160390627, Kit Lot Number 1614967; Model/Item Number (kit) SHOR001-15, UDI/DI 10809160390627, Kit Lot Number 1644461; Model/Item Number (kit) SHOR005-12, UDI/DI 10809160390504, Kit Lot Number 1592255; Model/Item Number (kit) SHOR005-12, UDI/DI 10809160390504, Kit Lot Number 1613423; Model/Item Number (kit) SHOR005-12, UDI/DI 10809160390504, Kit Lot Number 1614368; Model/Item Number (kit) SHOR005-12, UDI/DI 10809160390504, Kit Lot Number 1644463; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160440162, Kit Lot Number 1631480; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160440162, Kit Lot Number 1654403; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160488102, Kit Lot Number 1663961; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160440162, Kit Lot Number 1631504; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160488102, Kit Lot Number 1667105; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160488102, Kit Lot Number 1663960; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160488102, Kit Lot Number 1663959; Model/Item Number (kit) SLCR80-01, UDI/DI 10809160488102, Kit Lot Number 1667106; Model/Item Number (kit) SLDP19-01, UDI/DI 10809160487600, Kit Lot Number 1666282; Model/Item Number (kit) SLDP19-01, UDI/DI 10809160487600, Kit Lot Number 1670036; Model/Item Number (kit) SLDP19-01, UDI/DI 10809160450055, Kit Lot Number 1654404; Model/Item Number (kit) SLDP19-01, UDI/DI 10809160487600, Kit Lot Number 1700561; Model/Item Number (kit) SLDP19-01, UDI/DI 10809160487600, Kit Lot Number 1695108; Model/Item Number (kit) SPST001-06, UDI/DI 10809160464809, Kit Lot Number 1656777; Model/Item Number (kit) SPST001-06, UDI/DI 10809160464809, Kit Lot Number 1692410; Model/Item Number (kit) SPST001-06, UDI/DI 10809160464809, Kit Lot Number 1656775; Model/Item Number (kit) SPST001-06, UDI/DI 10809160464809, Kit Lot Number 1656776; Model/Item Number (kit) SWMR011-02, UDI/DI 10809160370872, Kit Lot Number 1659735; Model/Item Number (kit) SWMR011-02, UDI/DI 10809160370872, Kit Lot Number 1666375; Model/Item Number (kit) SWMR011-02, UDI/DI 10809160370872, Kit Lot Number 1673256; Model/Item Number (kit) SWMR011-02, UDI/DI 10809160370872, Kit Lot Number 1673257; Model/Item Number (kit) SWMR011-02, UDI/DI 10809160370872, Kit Lot Number 1680822; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1664508; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1666872; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1668885; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1691142; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1653638; Model/Item Number (kit) TPSP14-01, UDI/DI 10809160461143, Kit Lot Number 1666205; Model/Item Number (kit) VALD009-08, UDI/DI 10809160380833, Kit Lot Number 1662413; Model/Item Number (kit) VALD009-08, UDI/DI 10809160380833, Kit Lot Number 1637807; Model/Item Number (kit) VALD009-08, UDI/DI 10809160380833, Kit Lot Number 1645595; Model/Item Number (kit) VALD009-08, UDI/DI 10809160380833, Kit Lot Number 1658681; Model/Item Number (kit) VALD009-08, UDI/DI 10809160380833, Kit Lot Number 1602791; Model/Item Number (kit) VALV225-02, UDI/DI 10809160406250, Kit Lot Number 1629195; Model/Item Number (kit) VAST008-10, UDI/DI 10809160461334, Kit Lot Number 1641263; Model/Item Number (kit) WRNM033-22, UDI/DI 10809160470114, Kit Lot Number 1667341.
Distribution
US Nationwide distribution in the states of AZ, CA, CO, WA, WY, TX, MI, FL, MD, UT, NC, MS, PA, MO, IA, NE, OH, IL, SD, MN, GA.
Firm notified the public via
E-Mail
FDA event ID
99469
Recall initiated
May 19, 2026
FDA classified
August 28, 2026
FDA report date
September 9, 2026

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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