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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-2856-2018 | Class II | DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2855-2018 | Class II | DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2854-2018 | Class II | DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2853-2018 | Class II | DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2852-2018 | Class II | DigitalDiagnost 4.1 (Stitching Patient Support) 712225 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2851-2018 | Class II | DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2850-2018 | Class II | DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2849-2018 | Class II | DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2848-2018 | Class II | DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2847-2018 | Class II | CombiDiagnost R90 (Stitching Patient Support) 709030 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2846-2018 | Class II | BuckyDiagnost Ceiling System (Stitching Patient Support) 704031 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2845-2018 | Class II | DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2844-2018 | Class II | DigitalDiagnost Release 3 (Stitching Patient Support) 712025 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2843-2018 | Class II | DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2842-2018 | Class II | DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2884-2018 | Class II | Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE... | Stryker Corp. | HSB | |
| Z-2841-2018 | Class II | DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082 | Philips Medical Systems DMC GmbH | MQB | |
| Z-2470-2018 | Class II | Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout... | Ion Beam Applications S.A. | LHN | |
| Z-2751-2018 | Class II | Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two... | Terumo Cardiovascular Systems Corporation | DRY | |
| Z-2750-2018 | Class II | CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI... | Terumo Cardiovascular Systems Corporation | DRY | |
| Z-2600-2018 | Class II | Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS... | Encore Medical, LP | LRO | |
| Z-2590-2020 | Class II | This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic... | DJO, LLC | IMF | |
| Z-2080-2019 | Class II | POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit... | Bard Peripheral Vascular Inc | LJT | |
| Z-0108-2019 | Class II | Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF... | Carl Zeiss Meditec Inc | HJO | |
| Z-2659-2018 | Class II | Leica M530 OHX Microscope System Supplied with 100 - 120 Vac. | Leica Microsystems, Inc. | ||
| Z-0843-2019 | Class II | Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood... | Abbott Medical | JKA | |
| Z-0842-2019 | Class II | Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood... | Abbott Medical | JKA | |
| Z-2748-2018 | Class II | ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-2747-2018 | Class II | Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-2876-2018 | Class II | Persona Partial Knee System Spacer Block Alignment Tower, Item No... | Zimmer GmbH | LXH | |
| Z-2786-2018 | Class III | Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG... | Clarity Diagnostics, LLC | CDM | |
| Z-2915-2018 | Class II | AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2914-2018 | Class II | AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2913-2018 | Class II | AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2912-2018 | Class II | AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2911-2018 | Class II | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2910-2018 | Class II | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2909-2018 | Class II | QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2908-2018 | Class II | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2907-2018 | Class II | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2906-2018 | Class II | QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2905-2018 | Class II | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2904-2018 | Class II | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2903-2018 | Class II | QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2902-2018 | Class II | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2901-2018 | Class II | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2900-2018 | Class II | QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2899-2018 | Class II | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-2898-2018 | Class II | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number... | Stryker Leibinger GmbH & Co. KG | GWO | |
| Z-1004-2019 | Class II | Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; 545100L/... | Ossur Americas | KQZ |
