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 525 of 1191
FDA device recalls, page 525 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2493-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N329), IVD, REF 418631, 20 cards per...bioMerieux, Inc.N/A
Z-2492-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N328), IVD, REF 418630, 20 cards per...bioMerieux, Inc.N/A
Z-2491-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P642), IVD, REF 418604, 20 cards per...bioMerieux, Inc.N/A
Z-2490-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N324), IVD, REF 418603, 20 cards per...bioMerieux, Inc.N/A
Z-2489-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N323), IVD, REF 418602, 20 cards per...bioMerieux, Inc.N/A
Z-2488-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P641), IVD, REF 418590, 20 cards per...bioMerieux, Inc.N/A
Z-2487-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P640), IVD, REF 418579, 20 cards per...bioMerieux, Inc.N/A
Z-2486-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N327), IVD, REF 418515, 20 cards per...bioMerieux, Inc.N/A
Z-2485-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N325), IVD, REF 418513, 20 cards per...bioMerieux, Inc.N/A
Z-2484-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N322), IVD, REF 418489, 20 cards per...bioMerieux, Inc.N/A
Z-2483-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-GP76), IVD, REF 418424, 20 cards per...bioMerieux, Inc.LON
Z-2482-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P638), IVD, REF 418423, 20 cards per...bioMerieux, Inc.N/A
Z-2481-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N320), IVD, REF 418204, 20 cards per...bioMerieux, Inc.N/A
Z-2480-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N317), IVD, REF 417558, 20 cards per...bioMerieux, Inc.N/A
Z-2479-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N315), IVD, REF 417426, 20 cards per...bioMerieux, Inc.N/A
Z-2478-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N314), IVD, REF 417027, 20 cards per...bioMerieux, Inc.N/A
Z-2477-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N311), IVD, REF 416952, 20 cards per...bioMerieux, Inc.N/A
Z-2476-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P635), IVD, REF 416911, 20 cards per...bioMerieux, Inc.N/A
Z-2475-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N303), IVD, REF 416590, 20 cards per...bioMerieux, Inc.N/A
Z-2474-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N301), IVD, REF 416274, 20 cards per...bioMerieux, Inc.N/A
Z-2473-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N300), IVD, REF 416241, 20 cards per...bioMerieux, Inc.N/A
Z-2472-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N298), IVD, REF 416004, 20 cards per...bioMerieux, Inc.N/A
Z-2471-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N297), IVD, REF 415672, 20 cards per...bioMerieux, Inc.N/A
Z-2470-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P634), IVD, REF 415671, 20 cards per...bioMerieux, Inc.N/A
Z-2469-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-GP75), IVD, REF 415670, 20 cards per...bioMerieux, Inc.LON
Z-2468-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N293), REF 415369, 20 cards per carton.bioMerieux, Inc.N/A
Z-2467-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N292), REF 415063, 20 cards per carton.bioMerieux, Inc.N/A
Z-2466-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P632), REF 415059, 20 cards per carton.bioMerieux, Inc.N/A
Z-2465-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N290), REF 415058, 20 cards per carton.bioMerieux, Inc.N/A
Z-2464-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P633), REF 414994, 20 cards per carton.bioMerieux, Inc.N/A
Z-2463-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-GN93), REF 414985, 20 cards per carton.bioMerieux, Inc.LON
Z-2462-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-GP74), REF 414971, 20 cards per carton.bioMerieux, Inc.LON
Z-2461-2017Class IIVITEK 2 Gram Fungal Susceptibility card (AST-YS07), IVD, REF 414967, 20 cards per carton.bioMerieux, Inc.N/A
Z-2460-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-GN92), IVD, REF 414963, 20 cards per...bioMerieux, Inc.LON
Z-2459-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P631), REF 414961, 20 cards per carton.bioMerieux, Inc.N/A
Z-2458-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-GN91), REF 414780, 20 cards per carton.bioMerieux, Inc.LON
Z-2457-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-GN90), REF 414779, 20 cards per carton.bioMerieux, Inc.LON
Z-2456-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N286), REF 414778, 20 cards per carton.bioMerieux, Inc.N/A
Z-2455-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N285), REF 414740, 20 cards per carton.bioMerieux, Inc.N/A
Z-2454-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P629), REF 414576, 20 cards per carton.bioMerieux, Inc.N/A
Z-2453-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P628), REF 414534, 20 cards per carton.bioMerieux, Inc.N/A
Z-2452-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N281), REF 414532, 20 cards per carton.bioMerieux, Inc.N/A
Z-2451-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N279), REF 414492, 20 cards per carton.bioMerieux, Inc.N/A
Z-2450-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N275), REF 414313, 20 cards per carton.bioMerieux, Inc.N/A
Z-2449-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N276), REF 414286, 20 cards per carton.bioMerieux, Inc.N/A
Z-2448-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N272), REF 414164, 20 cards per carton.bioMerieux, Inc.N/A
Z-2447-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N271), REF 414163, 20 cards per carton.bioMerieux, Inc.N/A
Z-2446-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N270), REF 414162, 20 cards per carton.bioMerieux, Inc.N/A
Z-2445-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-XN06), REF 413944, 20 cards per carton.bioMerieux, Inc.LON
Z-2444-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-GN87), REF 413943, 20 cards per carton.bioMerieux, Inc.LON