510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,460 records, page 150 of 1190
FDA device recalls, page 150 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1521-2024Class IAW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway...Sonarmed, Inc.OQU
Z-1520-2024Class IAW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway...Sonarmed, Inc.OQU
Z-1519-2024Class IAW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway...Sonarmed, Inc.OQU
Z-1685-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624...Boston Scientific CorporationDQO
Z-1684-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982...Boston Scientific CorporationDQO
Z-1683-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962...Boston Scientific CorporationDQO
Z-1682-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892...Boston Scientific CorporationDQO
Z-1681-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862...Boston Scientific CorporationDQO
Z-1680-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842...Boston Scientific CorporationDQO
Z-1679-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2...Boston Scientific CorporationDQO
Z-1678-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF...Boston Scientific CorporationDQO
Z-1677-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2...Boston Scientific CorporationDQO
Z-1676-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF...Boston Scientific CorporationDQO
Z-1675-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512...Boston Scientific CorporationDQO
Z-1674-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511...Boston Scientific CorporationDQO
Z-1673-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF...Boston Scientific CorporationDQO
Z-1672-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502...Boston Scientific CorporationDQO
Z-1671-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501...Boston Scientific CorporationDQO
Z-1670-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF...Boston Scientific CorporationDQO
Z-1669-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF...Boston Scientific CorporationDQO
Z-1668-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF...Boston Scientific CorporationDQO
Z-1667-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF...Boston Scientific CorporationDQO
Z-1666-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF...Boston Scientific CorporationDQO
Z-1665-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF...Boston Scientific CorporationDQO
Z-1664-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532...Boston Scientific CorporationDQO
Z-1663-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF...Boston Scientific CorporationDQO
Z-1662-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252...Boston Scientific CorporationDQO
Z-1661-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502...Boston Scientific CorporationDQO
Z-1660-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF...Boston Scientific CorporationDQO
Z-1659-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF...Boston Scientific CorporationDQO
Z-1658-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232...Boston Scientific CorporationDQO
Z-1657-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF...Boston Scientific CorporationDQO
Z-1656-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF...Boston Scientific CorporationDQO
Z-1655-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222...Boston Scientific CorporationDQO
Z-1654-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF...Boston Scientific CorporationDQO
Z-1653-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212...Boston Scientific CorporationDQO
Z-1652-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2...Boston Scientific CorporationDQO
Z-1651-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032...Boston Scientific CorporationDQO
Z-1650-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022...Boston Scientific CorporationDQO
Z-1649-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012...Boston Scientific CorporationDQO
Z-1648-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952...Boston Scientific CorporationDQO
Z-1647-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902...Boston Scientific CorporationDQO
Z-1646-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802...Boston Scientific CorporationDQO
Z-1645-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712...Boston Scientific CorporationDQO
Z-1644-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002...Boston Scientific CorporationDQO
Z-1643-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF...Boston Scientific CorporationDQO
Z-1642-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042...Boston Scientific CorporationDQO
Z-1641-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032...Boston Scientific CorporationDQO
Z-1640-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031...Boston Scientific CorporationDQO
Z-1639-2024Class IExpo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022...Boston Scientific CorporationDQO