Recall archive / FDA device enforcement

Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (ki... — FDA record Z-3044-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 19, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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, Mo...
Reason: 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.
Classification: Class II
Recalling firm: AVID Medical, Inc.
Quantity: 11763 kits
Agency-reported status: Ongoing
Source record identifier: Z-3044-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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 16...

Label field

Details supplied by the agency

Lot, code or applicability

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 16...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Sep 9, 2026
Recall initiation date: May 19, 2026
Center classification date: Aug 28, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records