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

59,336 records, page 30 of 1187
FDA device recalls, page 30 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2586-2026Class IIConvenience kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-2585-2026Class IIConvenience kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2584-2026Class IIConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-2583-2026Class IIConvenience kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-2582-2026Class IIConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-2581-2026Class IIConvenience kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldOEQ
Z-1892-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-1891-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-1890-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1889-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E...MEDLINE INDUSTRIES, LP - NorthfieldKKX
Z-1888-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldOII
Z-1887-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-1886-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-1885-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-1884-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-1883-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1882-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-1881-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-1730-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-1880-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-1879-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-1878-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-1877-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-1876-2026Class IIMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes...MEDLINE INDUSTRIES, LP - NorthfieldOEQ
Z-1729-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-1728-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-1727-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-1726-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-1725-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)...MEDLINE INDUSTRIES, LP - NorthfieldKGO
Z-1724-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1723-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-1722-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-1721-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-1720-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-1719-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-1718-2026Class INAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-1717-2026Class INAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-1716-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)...MEDLINE INDUSTRIES, LP - NorthfieldOEQ
Z-1715-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)...MEDLINE INDUSTRIES, LP - NorthfieldDTL
Z-1714-2026Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)...MEDLINE INDUSTRIES, LP - NorthfieldOGJ
Z-1713-2026Class INAMIC Angiographic Control Syringe, labeled as follows: 1...MEDLINE INDUSTRIES, LP - NorthfieldDXT
Z-1712-2026Class INAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline...MEDLINE INDUSTRIES, LP - NorthfieldDXT
Z-1767-2026Class IISIGNA Premier systemsGE HealthcareLNH
Z-1768-2026Class IICardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777Medtronic, Inc.FMF
Z-1695-2026Class IIBrand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser...OLYMPUS Corporation of the AmericasGEX
Z-1694-2026Class IIBrand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE...OLYMPUS Corporation of the AmericasGEX
Z-1793-2026Class IIMulti-parameter Command Module, Model 91496, optioned with Masimo or NellcorGE HealthcareDSI
Z-1850-2026Class IIMedline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440MEDLINE INDUSTRIES, LP - NorthfieldOII
Z-1849-2026Class IIMedline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-1848-2026Class IIMedline Kits: 1) D AND C PACK, Model Number: DYNJ41254BMEDLINE INDUSTRIES, LP - NorthfieldOKV