510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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

59,544 records, page 617 of 1191
FDA device recalls, page 617 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2054-2016Class IISodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only...Nephron SC, LLC.CAF
Z-2053-2016Class IISodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per...Nephron SC, LLC.CAF
Z-0584-2016Class IIBIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HEAD 38 MM...Smith & Nephew, Inc.KWL
Z-0542-2016Class IIITHERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAUAmeditech, Inc.JXM
Z-0541-2016Class IIITHERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAUAmeditech, Inc.JXM
Z-0540-2016Class IIIRealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCAAmeditech, Inc.JXM
Z-0539-2016Class IIIProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-WAmeditech, Inc.JXM
Z-0538-2016Class IIIProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-WAmeditech, Inc.JXM
Z-0537-2016Class IIIProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-WAmeditech, Inc.JXM
Z-0536-2016Class IIIProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-WAmeditech, Inc.JXM
Z-0535-2016Class IIIProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-WAmeditech, Inc.JXM
Z-0534-2016Class IIIProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300Ameditech, Inc.JXM
Z-0533-2016Class IIIProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300Ameditech, Inc.JXM
Z-0532-2016Class IIIProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300Ameditech, Inc.JXM
Z-0531-2016Class IIIProScreen 8 Panel Dip Card, Item No. PSD-8PAmeditech, Inc.JXM
Z-0530-2016Class IIIProScreen 7 Panel Dip Card, Item No. PSD-7MPB, PSD-7MO, PSD-7MAmeditech, Inc.JXM
Z-0529-2016Class IIIProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3Ameditech, Inc.JXM
Z-0528-2016Class IIIProScreen 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAUAmeditech, Inc.JXM
Z-0527-2016Class IIIProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO...Ameditech, Inc.JXM
Z-0526-2016Class IIIProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAUAmeditech, Inc.JXM
Z-0525-2016Class IIIProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAUAmeditech, Inc.JXM
Z-0524-2016Class IIIProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB300Ameditech, Inc.JXM
Z-0523-2016Class IIIProScreen 5 Panel Dip Card, Item No. PSD-12BUPAmeditech, Inc.JXM
Z-0522-2016Class IIIProScreen 12 Panel Dip Card, Item No. PSD-12BUPAmeditech, Inc.JXM
Z-0521-2016Class IIIProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12MAmeditech, Inc.JXM
Z-0520-2016Class IIIProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBUAmeditech, Inc.JXM
Z-0519-2016Class IIIProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX...Ameditech, Inc.JXM
Z-0518-2016Class IIIProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300Ameditech, Inc.JXM
Z-0517-2016Class IIIProScProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AMAmeditech, Inc.JXM
Z-0516-2016Class IIIProScreen 10 Panel Cup, Item No. PSCup-10MAmeditech, Inc.JXM
Z-0515-2016Class IIIProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPXAmeditech, Inc.JXM
Z-0514-2016Class IIIMicro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAUAmeditech, Inc.JXM
Z-0513-2016Class IIIImmutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-WAmeditech, Inc.JXM
Z-0512-2016Class IIIImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7PAmeditech, Inc.JXM
Z-0511-2016Class IIIImmuTest 12 Panel Dip Card, Item No. IMD-12MO3Ameditech, Inc.JXM
Z-0510-2016Class IIIImmutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OPAmeditech, Inc.JXM
Z-0509-2016Class IIIImmutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-WAmeditech, Inc.JXM
Z-0508-2016Class IIIImmutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OPAmeditech, Inc.JXM
Z-0507-2016Class IIIImmutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5Ameditech, Inc.JXM
Z-0506-2016Class IIIiCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016Ameditech, Inc.JXM
Z-0505-2016Class IIIiCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013Ameditech, Inc.JXM
Z-0504-2016Class IIIiCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023Ameditech, Inc.JXM
Z-0503-2016Class IIIiCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131Ameditech, Inc.JXM
Z-0502-2016Class IIIiCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142Ameditech, Inc.JXM
Z-0501-2016Class IIIEDI BZO Uncut Sheet - Cup*, Item No. 160170Ameditech, Inc.JXM
Z-0500-2016Class IIIDrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520DAmeditech, Inc.JXM
Z-0499-2016Class IIIDrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600DAmeditech, Inc.JXM
Z-0498-2016Class IIIDrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600DAmeditech, Inc.JXM
Z-0497-2016Class IIIDrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015DAmeditech, Inc.JXM
Z-0496-2016Class IIIDrugSmart 9 Test Cup (BUP), Item No. 60960DAmeditech, Inc.JXM