510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

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 524 of 1191
FDA device recalls, page 524 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2142-2017Class IIJackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Single Use...Medtronic, Inc.GCY
Z-2141-2017Class IIJackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Single Use...Medtronic, Inc.GCY
Z-2140-2017Class IIJackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only...Medtronic, Inc.GCY
Z-2139-2017Class IIJackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single...Medtronic, Inc.GCY
Z-2138-2017Class IIJackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single...Medtronic, Inc.GCY
Z-2137-2017Class IIJackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx Only. For...Medtronic, Inc.GBX
Z-2136-2017Class IIJackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use...Medtronic, Inc.GBX
Z-2135-2017Class IIJackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx Only. For...Medtronic, Inc.GBX
Z-2134-2017Class IIJackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx Only. For...Medtronic, Inc.GBX
Z-2133-2017Class IIJackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. Sterile, Rx...Medtronic, Inc.GBX
Z-2132-2017Class IIJackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use Only...Medtronic, Inc.GBX
Z-2131-2017Class IIJackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For...Medtronic, Inc.GBX
Z-2130-2017Class IIINFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/AccessoryTeleflex MedicalGCD
Z-2129-2017Class IIPE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter...Teleflex MedicalGCD
Z-2128-2017Class IIPE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter...Teleflex MedicalGCD
Z-2127-2017Class IIPE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter...Teleflex MedicalGCD
Z-2527-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-GN67), IVD, REF 413399, 20 cards per...bioMerieux, Inc.LON
Z-2526-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-GN04), IVD, REF 22000, 20 cards per...bioMerieux, Inc.N/A
Z-2525-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N364), IVD, REF 421693, 20 cards per...bioMerieux, Inc.N/A
Z-2524-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N363), IVD, REF 421692, 20 cards per...bioMerieux, Inc.N/A
Z-2523-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N362), IVD, REF 421585, 20 cards per...bioMerieux, Inc.N/A
Z-2522-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N359), IVD, REF 421573, 20 cards per...bioMerieux, Inc.N/A
Z-2521-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N357), IVD, REF 421451, 20 cards per...bioMerieux, Inc.N/A
Z-2520-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N358), IVD, REF 421441, 20 cards per...bioMerieux, Inc.N/A
Z-2519-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N356), IVD, REF 421352, 20 cards per...bioMerieux, Inc.N/A
Z-2518-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N355), IVD, REF 421351, 20 cards per...bioMerieux, Inc.N/A
Z-2517-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N354), IVD, REF 421350, 20 cards per...bioMerieux, Inc.N/A
Z-2516-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N353), IVD, REF 421297, 20 cards per...bioMerieux, Inc.N/A
Z-2515-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P650), IVD, REF 421296, 20 cards per...bioMerieux, Inc.N/A
Z-2514-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N352), IVD, REF 421258, 20 cards per...bioMerieux, Inc.N/A
Z-2513-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N351), IVD, REF 421257, 20 cards per...bioMerieux, Inc.N/A
Z-2512-2017Class IIVITEK 2 Streptococcus Susceptibility card (AST-ST03), IVD, REF 421040, 20 cards per...bioMerieux, Inc.N/A
Z-2511-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N350), IVD, REF 421037, 20 cards per...bioMerieux, Inc.LON
Z-2510-2017Class IIVITEK 2 Streptococcus Susceptibility card (AST-ST02), IVD, REF 420915, 20 cards per...bioMerieux, Inc.LON
Z-2509-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P649), IVD, REF 420858, 20 cards per...bioMerieux, Inc.N/A
Z-2508-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P648), IVD, REF 420857, 20 cards per...bioMerieux, Inc.N/A
Z-2507-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N348), IVD, REF 420856, 20 cards per...bioMerieux, Inc.N/A
Z-2506-2017Class IIVITEK 2 Fungal Susceptibility card (AST-YS08), IVD, REF 420739, 20 cards per carton.bioMerieux, Inc.N/A
Z-2505-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N345), IVD, REF 420580, 20 cards per...bioMerieux, Inc.N/A
Z-2504-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N344), IVD, REF 420440, 20 cards per...bioMerieux, Inc.N/A
Z-2503-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P646), IVD, REF 420144, 20 cards per...bioMerieux, Inc.N/A
Z-2502-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P645), IVD, REF 419602, 20 cards per...bioMerieux, Inc.N/A
Z-2501-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N340), IVD, REF 419412, 20 cards per...bioMerieux, Inc.N/A
Z-2500-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N339), IVD, REF 419341, 20 cards per...bioMerieux, Inc.N/A
Z-2499-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N335), IVD, REF 418985, 20 cards per...bioMerieux, Inc.N/A
Z-2498-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N334), IVD, REF 418984, 20 cards per...bioMerieux, Inc.N/A
Z-2497-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N331), IVD, REF 418675, 20 cards per...bioMerieux, Inc.N/A
Z-2496-2017Class IIVITEK 2 Gram Negative Susceptibility card (AST-N330), IVD, REF 418674, 20 cards per...bioMerieux, Inc.N/A
Z-2495-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P644), IVD, REF 418673, 20 cards per...bioMerieux, Inc.N/A
Z-2494-2017Class IIVITEK 2 Gram Positive Susceptibility card (AST-P643), IVD, REF 418671, 20 cards per...bioMerieux, Inc.N/A