AVID Medical, Inc. recalls Halyard medical convenience kits labeled as: 1) ENT
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- Part / Item #
- (kit) ACEN89-01, UDI/DI 10809160459447, Kit
- Lot #
- 1650691; Model/
- Part / Item #
- (kit) ACEN89-01, UDI/DI 10809160496411, Kit
- Lot #
- 1675577; Model/
- Part / Item #
- (kit) ACEN89-01, UDI/DI 10809160459447, Kit
- Lot #
- 1666553; Model/
- Part / Item #
- (kit) ACEN89-02, UDI/DI 10809160505304, Kit
- Lot #
- 1683926; Model/
- Part / Item #
- (kit) ACEN89-02, UDI/DI 10809160505304, Kit
- Lot #
- 1683927; Model/
- Part / Item #
- (kit) ALBK51-01, UDI/DI 10809160458587, Kit
- Lot #
- 1649240; Model/
- Part / Item #
- (kit) ALBK51-01, UDI/DI 10809160458587, Kit
- Lot #
- 1649721; Model/
- Part / Item #
- (kit) ALBK51-01, UDI/DI 10809160496374, Kit
- Lot #
- 1675589; Model/
- Part / Item #
- (kit) DGSP71, UDI/DI 10809160468036, Kit
- Lot #
- 1659332; Model/
- Part / Item #
- (kit) DRBS37, UDI/DI 10809160466858, Kit
- Lot #
- 1658530; Model/
- Part / Item #
- (kit) DRBS37-01, UDI/DI 10809160503829, Kit
- Lot #
- 1681363; Model/
- Part / Item #
- (kit) DRBS37-01, UDI/DI 10809160503829, Kit
- Lot #
- 1681470; Model/
- Part / Item #
- (kit) DRBS37-01, UDI/DI 10809160503829, Kit
- Lot #
- 1691461; Model/
- Part / Item #
- (kit) DRNS92, UDI/DI 10809160466346, Kit
- Lot #
- 1658536; Model/
- Part / Item #
- (kit) DRNS92-01, UDI/DI 10809160503942, Kit
- Lot #
- 1681504; Model/
- Part / Item #
- (kit) DRNS92-02, UDI/DI 10809160509463, Kit
- Lot #
- 1696890; Model/
- Part / Item #
- (kit) DRSP26, UDI/DI 10809160466384, Kit
- Lot #
- 1659340; Model/
- Part / Item #
- (kit) DRSP26-01, UDI/DI 10809160505113, Kit
- Lot #
- 1683469; Model/
- Part / Item #
- (kit) DRSP26-02, UDI/DI 10809160509470, Kit
- Lot #
- 1691780; Model/
- Part / Item #
- (kit) DRSP52, UDI/DI 10809160466391, Kit
- Lot #
- 1658538; Model/
- Part / Item #
- (kit) DRSP52-01, UDI/DI 10809160503928, Kit
- Lot #
- 1681522; Model/
- Part / Item #
- (kit) DRSP52-01, UDI/DI 10809160503928, Kit
- Lot #
- 1690963; Model/
- Part / Item #
- (kit) DULY32, UDI/DI 10809160491713, Kit
- Lot #
- 1672111; Model/
- Part / Item #
- (kit) DULY32-01, UDI/DI 10809160506752, Kit
- Lot #
- 1684863; Model/
- Part / Item #
- (kit) DUMF13-01, UDI/DI 10809160498194, Kit
- Lot #
- 1675866; Model/
- Part / Item #
- (kit) DUMF13-02, UDI/DI 10809160513668, Kit
- Lot #
- 1696000; Model/
- Part / Item #
- (kit) DUNS94, UDI/DI 10809160493380, Kit
- Lot #
- 1672112; Model/
- Part / Item #
- (kit) DUNS94-01, UDI/DI 10809160513309, Kit
- Lot #
- 1696906; Model/
- Part / Item #
- (kit) DUPS11-01, UDI/DI 10809160497654, Kit
- Lot #
- 1675527; Model/
- Part / Item #
- (kit) DUPS11-02, UDI/DI 10809160514245, Kit
- Lot #
- 1696671; Model/
- Part / Item #
- (kit) DUTM67-01, UDI/DI 10809160498255, Kit
- Lot #
- 1675954; Model/
- Part / Item #
- (kit) DVSP33J, UDI/DI 10809160488256, Kit
- Lot #
- 1663944; Model/
- Part / Item #
- (kit) DVSP33J, UDI/DI 10809160422601, Kit
- Lot #
- 1630941; Model/
- Part / Item #
- (kit) DVSP33J, UDI/DI 10809160488256, Kit
- Lot #
- 1668872; Model/
- Part / Item #
- (kit) DVSP33J, UDI/DI 10809160488256, Kit
- Lot #
- 1668873; Model/
- Part / Item #
- (kit) DVSP33J, UDI/DI 10809160488256, Kit
- Lot #
- 1663942; Model/
- Part / Item #
- (kit) DVSP33J, UDI/DI 10809160488256, Kit
- Lot #
- 1663941; Model/
- Part / Item #
- (kit) DVSP33J, UDI/DI 10809160488256, Kit
- Lot #
- 1693905; Model/
- Part / Item #
- (kit) EAMC108-03, UDI/DI 10809160308332, Kit
- Lot #
- 1648525; Model/
- Part / Item #
- (kit) EAMC108-03, UDI/DI 10809160308332, Kit
- Lot #
- 1657459; Model/
- Part / Item #
- (kit) EAMC124, UDI/DI 10809160404799, Kit
- Lot #
- 1647073; Model/
- Part / Item #
- (kit) EAMC124, UDI/DI 10809160404799, Kit
- Lot #
- 1652746; Model/
- Part / Item #
- (kit) EAMC124, UDI/DI 10809160404799, Kit
- Lot #
- 1653958; Model/
- Part / Item #
- (kit) EAMC124, UDI/DI 10809160404799, Kit
- Lot #
- 1663289; Model/
- Part / Item #
- (kit) EAMC124, UDI/DI 10809160404799, Kit
- Lot #
- 1668701; Model/
- Part / Item #
- (kit) EAMC124, UDI/DI 10809160404799, Kit
- Lot #
- 1702932; Model/
- Part / Item #
- (kit) EFSN20-01, UDI/DI 10809160442104, Kit
- Lot #
- 1633240; Model/
- Part / Item #
- (kit) EFSN20-01, UDI/DI 10809160456132, Kit
- Lot #
- 1646885; Model/
- Part / Item #
- (kit) EFSN20-01, UDI/DI 10809160456132, Kit
- Lot #
- 1679527; Model/
- Part / Item #
- (kit) EFSN20-01, UDI/DI 10809160456132, Kit
- Lot #
- 1666246; Model/
- Part / Item #
- (kit) EFSN20-01, UDI/DI 10809160456132, Kit
- Lot #
- 1666500; Model/
- Part / Item #
- (kit) EFSN20-01, UDI/DI 10809160456132, Kit
- Lot #
- 1667490; Model/
- Part / Item #
- (kit) EFSN20-01, UDI/DI 10809160456132, Kit
- Lot #
- 1696290; Model/
- Part / Item #
- (kit) EFSN20-01, UDI/DI 10809160456132, Kit
- Lot #
- 1697819; Model/
- Part / Item #
- (kit) EUOR004-04, UDI/DI 10809160436172, Kit
- Lot #
- 1627776; Model/
- Part / Item #
- (kit) EUOR004-04, UDI/DI 10809160457252, Kit
- Lot #
- 1668123; Model/
- Part / Item #
- (kit) HOSP20I, UDI/DI 10809160488133, Kit
- Lot #
- 1665330; Model/
- Part / Item #
- (kit) HOSP20I, UDI/DI 10809160488133, Kit
- Lot #
- 1669003; Model/
- Part / Item #
- (kit) HOSP20I, UDI/DI 10809160488133, Kit
- Lot #
- 1671045; Model/
- Part / Item #
- (kit) HOSP20I, UDI/DI 10809160488133, Kit
- Lot #
- 1693989; Model/
- Part / Item #
- (kit) HOSP20I, UDI/DI 10809160488133, Kit
- Lot #
- 1664462; Model/
- Part / Item #
- (kit) HOSP20I, UDI/DI 10809160488133, Kit
- Lot #
- 374805; Model/
- Part / Item #
- (kit) HOSP20I, UDI/DI 10809160488133, Kit
- Lot #
- 374807; Model/
- Part / Item #
- (kit) HOSP20I, UDI/DI 10809160488133, Kit
- Lot #
- 375045; Model/
- Part / Item #
- (kit) JACK401-07, UDI/DI 10809160457122, Kit
- Lot #
- 1647194; Model/
- Part / Item #
- (kit) JACK401-08, UDI/DI 10809160465004, Kit
- Lot #
- 1656191; Model/
- Part / Item #
- (kit) JACK401-08, UDI/DI 10809160465004, Kit
- Lot #
- 1647195; Model/
- Part / Item #
- (kit) JACK401-08, UDI/DI 10809160465004, Kit
- Lot #
- 1664711; Model/
- Part / Item #
- (kit) JACK401-08, UDI/DI 10809160465004, Kit
- Lot #
- 1672072; Model/
- Part / Item #
- (kit) JACK401-08, UDI/DI 10809160465004, Kit
- Lot #
- 1664712; Model/
- Part / Item #
- (kit) JACK401-08, UDI/DI 10809160465004, Kit
- Lot #
- 1656190; Model/
- Part / Item #
- (kit) JACK401-09, UDI/DI 10809160493335, Kit
- Lot #
- 1672074; Model/
- Part / Item #
- (kit) JACK401-09, UDI/DI 10809160493335, Kit
- Lot #
- 1672073; Model/
- Part / Item #
- (kit) JACK401-09, UDI/DI 10809160521922, Kit
- Lot #
- 852288; Model/
- Part / Item #
- (kit) JACK401-09, UDI/DI 10809160521922, Kit
- Lot #
- 852289; Model/
- Part / Item #
- (kit) JACK401-09, UDI/DI 10809160521922, Kit
- Lot #
- 857175; Model/
- Part / Item #
- (kit) JACK401-09, UDI/DI 10809160521922, Kit
- Lot #
- 858450; Model/
- Part / Item #
- (kit) JACK401-09, UDI/DI 10809160521922, Kit
- Lot #
- 863863; Model/
- Part / Item #
- (kit) JCSP60F, UDI/DI 10809160423189, Kit
- Lot #
- 1624320; Model/
- Part / Item #
- (kit) JCSP60F, UDI/DI 10809160423189, Kit
- Lot #
- 1624321; Model/
- Part / Item #
- (kit) JCSP60F, UDI/DI 10809160423189, Kit
- Lot #
- 1632235; Model/
- Part / Item #
- (kit) JCSP60F, UDI/DI 10809160423189, Kit
- Lot #
- 1624322; Model/
- Part / Item #
- (kit) JCSP60F, UDI/DI 10809160423189, Kit
- Lot #
- 1673702; Model/
- Part / Item #
- (kit) JCSP60F, UDI/DI 10809160423189, Kit
- Lot #
- 1664473; Model/
- Part / Item #
- (kit) JCSP60F, UDI/DI 10809160423189, Kit
- Lot #
- 1657644; Model/
- Part / Item #
- (kit) JCSP60F, UDI/DI 10809160423189, Kit
- Lot #
- 1671055; Model/
- Part / Item #
- (kit) JCSP60F, UDI/DI 10809160423189, Kit
- Lot #
- 1662136; Model/
- Part / Item #
- (kit) JEBK01-01, UDI/DI 10809160443132, Kit
- Lot #
- 1634523; Model/
- Part / Item #
- (kit) JEBK01-01, UDI/DI 10809160443132, Kit
- Lot #
- 1634522; Model/
- Part / Item #
- (kit) JEBK01-01, UDI/DI 10809160443132, Kit
- Lot #
- 1643364; Model/
- Part / Item #
- (kit) LBPS18-01, UDI/DI 10809160438169, Kit
- Lot #
- 1630467; Model/
- Part / Item #
- (kit) LBPS18-01, UDI/DI 10809160438169, Kit
- Lot #
- 1630023; Model/
- Part / Item #
- (kit) LBPS18-01, UDI/DI 10809160438169, Kit
- Lot #
- 1639340; Model/
- Part / Item #
- (kit) LBPS18-01, UDI/DI 10809160438169, Kit
- Lot #
- 1658421; Model/
- Part / Item #
- (kit) LBPS18-01, UDI/DI 10809160438169, Kit
- Lot #
- 1666815; Model/
- Part / Item #
- (kit) LBSN49-01, UDI/DI 10809160438183, Kit
- Lot #
- 1639341; Model/
- Part / Item #
- (kit) LBSN49-01, UDI/DI 10809160438183, Kit
- Lot #
- 1629949; Model/
- Part / Item #
- (kit) LBSN49-01, UDI/DI 10809160438183, Kit
- Lot #
- 1635273; Model/
- Part / Item #
- (kit) LBSN49-01, UDI/DI 10809160461396, Kit
- Lot #
- 1652833; Model/
- Part / Item #
- (kit) LBSN49-01, UDI/DI 10809160461396, Kit
- Lot #
- 1652834; Model/
- Part / Item #
- (kit) LBSN49-01, UDI/DI 10809160496459, Kit
- Lot #
- 1676545; Model/
- Part / Item #
- (kit) LBSN49-01, UDI/DI 10809160496459, Kit
- Lot #
- 371520; Model/
- Part / Item #
- (kit) LBSN49-01, UDI/DI 10809160496459, Kit
- Lot #
- 1691995; Model/
- Part / Item #
- (kit) LBSN49-01, UDI/DI 10809160496459, Kit
- Lot #
- 351420; Model/
- Part / Item #
- (kit) MAMC251-09, UDI/DI 10809160504956, Kit
- Lot #
- 1694232; Model/
- Part / Item #
- (kit) NAFB071-10, UDI/DI 10809160466025, Kit
- Lot #
- 1659349; Model/
- Part / Item #
- (kit) NAFB071-10, UDI/DI 10809160466025, Kit
- Lot #
- 1659350; Model/
- Part / Item #
- (kit) OSSP27-01, UDI/DI 10809160437391, Kit
- Lot #
- 1666862; Model/
- Part / Item #
- (kit) OSSP27-01, UDI/DI 10809160437391, Kit
- Lot #
- 1661830; Model/
- Part / Item #
- (kit) OSSP27-01, UDI/DI 10809160437391, Kit
- Lot #
- 1666863; Model/
- Part / Item #
- (kit) OSSP27-01, UDI/DI 10809160437391, Kit
- Lot #
- 1669024; Model/
- Part / Item #
- (kit) OSSP27-01, UDI/DI 10809160437391, Kit
- Lot #
- 1694083; Model/
- Part / Item #
- (kit) OSSP27-01, UDI/DI 10809160437391, Kit
- Lot #
- 1665985; Model/
- Part / Item #
- (kit) OSSP27-01, UDI/DI 10809160522011, Kit
- Lot #
- 1629904; Model/
- Part / Item #
- (kit) SAMM029-17, UDI/DI 10809160439746, Kit
- Lot #
- 1628621; Model/
- Part / Item #
- (kit) SELF112-03, UDI/DI 10809160458761, Kit
- Lot #
- 1669327; Model/
- Part / Item #
- (kit) SELF112-03, UDI/DI 10809160458761, Kit
- Lot #
- 1674472; Model/
- Part / Item #
- (kit) SHAN415-01, UDI/DI 10809160426005, Kit
- Lot #
- 1664121; Model/
- Part / Item #
- (kit) SHAN415-01, UDI/DI 10809160426005, Kit
- Lot #
- 1622345; Model/
- Part / Item #
- (kit) SHAN415-01, UDI/DI 10809160426005, Kit
- Lot #
- 1651571; Model/
- Part / Item #
- (kit) SHAN415-01, UDI/DI 10809160426005, Kit
- Lot #
- 1664960; Model/
- Part / Item #
- (kit) SHAN415-01, UDI/DI 10809160426005, Kit
- Lot #
- 1669881; Model/
- Part / Item #
- (kit) SHAN415-01, UDI/DI 10809160426005, Kit
- Lot #
- 1691644; Model/
- Part / Item #
- (kit) SHAN415-01, UDI/DI 10809160426005, Kit
- Lot #
- 1668350; Model/
- Part / Item #
- (kit) SHOR001-15, UDI/DI 10809160390627, Kit
- Lot #
- 1628492; Model/
- Part / Item #
- (kit) SHOR001-15, UDI/DI 10809160390627, Kit
- Lot #
- 1603012; Model/
- Part / Item #
- (kit) SHOR001-15, UDI/DI 10809160390627, Kit
- Lot #
- 1614967; Model/
- Part / Item #
- (kit) SHOR001-15, UDI/DI 10809160390627, Kit
- Lot #
- 1644461; Model/
- Part / Item #
- (kit) SHOR005-12, UDI/DI 10809160390504, Kit
- Lot #
- 1592255; Model/
- Part / Item #
- (kit) SHOR005-12, UDI/DI 10809160390504, Kit
- Lot #
- 1613423; Model/
- Part / Item #
- (kit) SHOR005-12, UDI/DI 10809160390504, Kit
- Lot #
- 1614368; Model/
- Part / Item #
- (kit) SHOR005-12, UDI/DI 10809160390504, Kit
- Lot #
- 1644463; Model/
- Part / Item #
- (kit) SLCR80-01, UDI/DI 10809160440162, Kit
- Lot #
- 1631480; Model/
- Part / Item #
- (kit) SLCR80-01, UDI/DI 10809160440162, Kit
- Lot #
- 1654403; Model/
- Part / Item #
- (kit) SLCR80-01, UDI/DI 10809160488102, Kit
- Lot #
- 1663961; Model/
- Part / Item #
- (kit) SLCR80-01, UDI/DI 10809160440162, Kit
- Lot #
- 1631504; Model/
- Part / Item #
- (kit) SLCR80-01, UDI/DI 10809160488102, Kit
- Lot #
- 1667105; Model/
- Part / Item #
- (kit) SLCR80-01, UDI/DI 10809160488102, Kit
- Lot #
- 1663960; Model/
- Part / Item #
- (kit) SLCR80-01, UDI/DI 10809160488102, Kit
- Lot #
- 1663959; Model/
- Part / Item #
- (kit) SLCR80-01, UDI/DI 10809160488102, Kit
- Lot #
- 1667106; Model/
- Part / Item #
- (kit) SLDP19-01, UDI/DI 10809160487600, Kit
- Lot #
- 1666282; Model/
- Part / Item #
- (kit) SLDP19-01, UDI/DI 10809160487600, Kit
- Lot #
- 1670036; Model/
- Part / Item #
- (kit) SLDP19-01, UDI/DI 10809160450055, Kit
- Lot #
- 1654404; Model/
- Part / Item #
- (kit) SLDP19-01, UDI/DI 10809160487600, Kit
- Lot #
- 1700561; Model/
- Part / Item #
- (kit) SLDP19-01, UDI/DI 10809160487600, Kit
- Lot #
- 1695108; Model/
- Part / Item #
- (kit) SPST001-06, UDI/DI 10809160464809, Kit
- Lot #
- 1656777; Model/
- Part / Item #
- (kit) SPST001-06, UDI/DI 10809160464809, Kit
- Lot #
- 1692410; Model/
- Part / Item #
- (kit) SPST001-06, UDI/DI 10809160464809, Kit
- Lot #
- 1656775; Model/
- Part / Item #
- (kit) SPST001-06, UDI/DI 10809160464809, Kit
- Lot #
- 1656776; Model/
- Part / Item #
- (kit) SWMR011-02, UDI/DI 10809160370872, Kit
- Lot #
- 1659735; Model/
- Part / Item #
- (kit) SWMR011-02, UDI/DI 10809160370872, Kit
- Lot #
- 1666375; Model/
- Part / Item #
- (kit) SWMR011-02, UDI/DI 10809160370872, Kit
- Lot #
- 1673256; Model/
- Part / Item #
- (kit) SWMR011-02, UDI/DI 10809160370872, Kit
- Lot #
- 1673257; Model/
- Part / Item #
- (kit) SWMR011-02, UDI/DI 10809160370872, Kit
- Lot #
- 1680822; Model/
- Part / Item #
- (kit) TPSP14-01, UDI/DI 10809160461143, Kit
- Lot #
- 1664508; Model/
- Part / Item #
- (kit) TPSP14-01, UDI/DI 10809160461143, Kit
- Lot #
- 1666872; Model/
- Part / Item #
- (kit) TPSP14-01, UDI/DI 10809160461143, Kit
- Lot #
- 1668885; Model/
- Part / Item #
- (kit) TPSP14-01, UDI/DI 10809160461143, Kit
- Lot #
- 1691142; Model/
- Part / Item #
- (kit) TPSP14-01, UDI/DI 10809160461143, Kit
- Lot #
- 1653638; Model/
- Part / Item #
- (kit) TPSP14-01, UDI/DI 10809160461143, Kit
- Lot #
- 1666205; Model/
- Part / Item #
- (kit) VALD009-08, UDI/DI 10809160380833, Kit
- Lot #
- 1662413; Model/
- Part / Item #
- (kit) VALD009-08, UDI/DI 10809160380833, Kit
- Lot #
- 1637807; Model/
- Part / Item #
- (kit) VALD009-08, UDI/DI 10809160380833, Kit
- Lot #
- 1645595; Model/
- Part / Item #
- (kit) VALD009-08, UDI/DI 10809160380833, Kit
- Lot #
- 1658681; Model/
- Part / Item #
- (kit) VALD009-08, UDI/DI 10809160380833, Kit
- Lot #
- 1602791; Model/
- Part / Item #
- (kit) VALV225-02, UDI/DI 10809160406250, Kit
- Lot #
- 1629195; Model/
- Part / Item #
- (kit) VAST008-10, UDI/DI 10809160461334, Kit
- Lot #
- 1641263; Model/
- Part / Item #
- (kit) WRNM033-22, UDI/DI 10809160470114, Kit
- Lot #
- 1667341
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What the firm is doing
Owens & Minor issued an URGENT: MEDICAL DEVICE RECALL NOTIFICATION to its consignees on 5/19/2026 via email. The notice explained the issue, potential risk to health and requested the following: "ACTIONS TO TAKE: " Identify, segregate, and quarantine all impacted product. " Add recall labels to affected Avid kits to ensure all users are aware of the actions to discard the impacted component. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Please contact your Sales Representative if pre-printed labels are needed. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. " Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. " Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness."
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3044-2026
- FDA device classification · LROOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4370The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find AVID Medical, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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