Class 2 Device Recall Halyard

• Date Initiated by Firm: May 19, 2026
• Date Posted: August 28, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3044-2026
• Recall Event ID: 99469
• Product Classification: General surgery tray - Product Code LRO
• 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, 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.
• Code Information: 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.
• FEI Number: 1047429
• Recalling Firm/ Manufacturer: AVID Medical, Inc.; 9000 Westmont Dr; Toano VA 23168-9351
• For Additional Information Contact: Marlene Jones; 470-280-4277
• Manufacturer 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.
• FDA Determined Cause: Material/Component Contamination
• Action: 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."
• Quantity in Commerce: 11763 kits
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.