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

59,528 records, page 451 of 1191
FDA device recalls, page 451 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2856-2018Class IIDigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081Philips Medical Systems DMC GmbHMQB
Z-2855-2018Class IIDigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031Philips Medical Systems DMC GmbHMQB
Z-2854-2018Class IIDigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028Philips Medical Systems DMC GmbHMQB
Z-2853-2018Class IIDigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029Philips Medical Systems DMC GmbHMQB
Z-2852-2018Class IIDigitalDiagnost 4.1 (Stitching Patient Support) 712225Philips Medical Systems DMC GmbHMQB
Z-2851-2018Class IIDigitalDiagnost 4 High Performance (Stitching Patient Support) 712027Philips Medical Systems DMC GmbHMQB
Z-2850-2018Class IIDigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028Philips Medical Systems DMC GmbHMQB
Z-2849-2018Class IIDigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029Philips Medical Systems DMC GmbHMQB
Z-2848-2018Class IIDigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081Philips Medical Systems DMC GmbHMQB
Z-2847-2018Class IICombiDiagnost R90 (Stitching Patient Support) 709030Philips Medical Systems DMC GmbHMQB
Z-2846-2018Class IIBuckyDiagnost Ceiling System (Stitching Patient Support) 704031Philips Medical Systems DMC GmbHMQB
Z-2845-2018Class IIDigitalDiagnost Release 3.1 (Stitching Patient Support) 712026Philips Medical Systems DMC GmbHMQB
Z-2844-2018Class IIDigitalDiagnost Release 3 (Stitching Patient Support) 712025Philips Medical Systems DMC GmbHMQB
Z-2843-2018Class IIDigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031Philips Medical Systems DMC GmbHMQB
Z-2842-2018Class IIDigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028Philips Medical Systems DMC GmbHMQB
Z-2884-2018Class IIStryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE...Stryker Corp.HSB
Z-2841-2018Class IIDigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082Philips Medical Systems DMC GmbHMQB
Z-2470-2018Class IIProteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout...Ion Beam Applications S.A.LHN
Z-2751-2018Class IIMonitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two...Terumo Cardiovascular Systems CorporationDRY
Z-2750-2018Class IICDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI...Terumo Cardiovascular Systems CorporationDRY
Z-2600-2018Class IIInstrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS...Encore Medical, LPLRO
Z-2590-2020Class IIThis is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic...DJO, LLCIMF
Z-2080-2019Class IIPOWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit...Bard Peripheral Vascular IncLJT
Z-0108-2019Class IICarl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF...Carl Zeiss Meditec IncHJO
Z-2659-2018Class IILeica M530 OHX Microscope System Supplied with 100 - 120 Vac.Leica Microsystems, Inc.
Z-0843-2019Class IIAplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood...Abbott MedicalJKA
Z-0842-2019Class IIAplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood...Abbott MedicalJKA
Z-2748-2018Class IIARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product...Siemens Medical Solutions USA, Inc.OWB
Z-2747-2018Class IIArtis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353...Siemens Medical Solutions USA, Inc.OWB
Z-2876-2018Class IIPersona Partial Knee System Spacer Block Alignment Tower, Item No...Zimmer GmbHLXH
Z-2786-2018Class IIIClarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG...Clarity Diagnostics, LLCCDM
Z-2915-2018Class IIAXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S...Stryker Leibinger GmbH & Co. KGGWO
Z-2914-2018Class IIAXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part...Stryker Leibinger GmbH & Co. KGGWO
Z-2913-2018Class IIAXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part...Stryker Leibinger GmbH & Co. KGGWO
Z-2912-2018Class IIAXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S...Stryker Leibinger GmbH & Co. KGGWO
Z-2911-2018Class IIAXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number...Stryker Leibinger GmbH & Co. KGGWO
Z-2910-2018Class IIAXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number...Stryker Leibinger GmbH & Co. KGGWO
Z-2909-2018Class IIQUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S...Stryker Leibinger GmbH & Co. KGGWO
Z-2908-2018Class IIQUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part...Stryker Leibinger GmbH & Co. KGGWO
Z-2907-2018Class IIQUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part...Stryker Leibinger GmbH & Co. KGGWO
Z-2906-2018Class IIQUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number...Stryker Leibinger GmbH & Co. KGGWO
Z-2905-2018Class IIQUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number...Stryker Leibinger GmbH & Co. KGGWO
Z-2904-2018Class IIQUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number...Stryker Leibinger GmbH & Co. KGGWO
Z-2903-2018Class IIQUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S...Stryker Leibinger GmbH & Co. KGGWO
Z-2902-2018Class IIQUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part...Stryker Leibinger GmbH & Co. KGGWO
Z-2901-2018Class IIQUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part...Stryker Leibinger GmbH & Co. KGGWO
Z-2900-2018Class IIQUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number...Stryker Leibinger GmbH & Co. KGGWO
Z-2899-2018Class IIQUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number...Stryker Leibinger GmbH & Co. KGGWO
Z-2898-2018Class IIQUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number...Stryker Leibinger GmbH & Co. KGGWO
Z-1004-2019Class IIOssur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; 545100L/...Ossur AmericasKQZ