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-0092-2012 | "***REF BLU-5***5 mm Fluted Ball. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile... | The Anspach Effort, Inc. | HTT | ||
| Z-0091-2012 | "***REF QD8-5B***5 mm Fluted Ball. Use with QD8 Attachments. ***ANSPACH***Sterile... | The Anspach Effort, Inc. | HTT | ||
| Z-0090-2012 | "***REF QD11-6B***6 mm Fluted Ball. Use with QD11 Attachments. ***ANSPACH***Sterile... | The Anspach Effort, Inc. | HTT | ||
| Z-2136-2008 | Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic... | AGFA Healthcare Corp. | LMC | ||
| Z-2134-2008 | Vacuette, Plastic Cannula HOLDEX, Ref 450216, Single packed, sterile, single use... | Greiner Bio-One North America, Inc. | FMI | ||
| Z-1863-2008 | Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument, non-sterile... | Zimmer GmbH | LXH | ||
| Z-1881-2008 | Biomet OSS Interlok IM Stem w/Screw, straight collar, 15 mm x 225 mm, TI6AL4V alloy... | Zimmer GmbH | KRO | ||
| Z-1880-2008 | Biomet OSS Interlok IM Stem w/Screw, straight collar, 13 mm x 225 mm, TI6AL4V alloy... | Zimmer GmbH | KRO | ||
| Z-1879-2008 | Biomet OSS Interlok IM Stem w/Screw, straight collar, 11 mm x 225 mm, TI6AL4V alloy... | Zimmer GmbH | KRO | ||
| Z-2104-2008 | Radiation therapy system - PRIMEVIEW 3i System 2.1 equipped with Coherence Therapist... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2103-2008 | Radiation therapy system - Coherence Therapist System 2.1 equipped with Coherence... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2102-2008 | Radiation therapy system - PRIMEVIEW 3i System 2.0 equipped with Coherence Therapist... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2101-2008 | Radiation therapy system - Coherence Therapist 2.0 equipped with Coherence Therapist... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2100-2008 | Radiation therapy system - Syngo Based WS for 3rd party V&R equipped with Coherence... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2099-2008 | Radiation therapy system - Impression Therapist 3rd party V&R equipped with Coherence... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2098-2008 | Radiation therapy system - AG Therapist 3rd party V&R equipped with Coherence Therapist... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2097-2008 | Radiation therapy system - PRIMEVIEW 3i System equipped with a Coherence Therapist RTT2.1... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2096-2008 | Radiation therapy system - Coherence Impression Therapist System equipped with a... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2095-2008 | Radiation therapy system - Coherence AG Therapist Part number 5863506 and Therapist... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2574-2011 | XiO Radiation Treatment Planning System, XiO Release 1.5.0 and above. Used to create... | Elekta Limited | muj | ||
| Z-2138-2008 | GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx... | SYNOVIS MICRO COMPANIES ALLIANCE, Inc. (a subsidiary of Baxter International Inc.) | MVR | ||
| Z-2158-2008 | Stem Trial, Triathlon Revision Instruments; Non-Sterile; 150 mm length Catalog... | Howmedica Osteonics Corp | HWT | ||
| Z-2157-2008 | Stem Trial, Triathlon Revision Instruments; Non-Sterile; 100 mm length Catalog numbers... | Howmedica Osteonics Corp | HWT | ||
| Z-2107-2008 | Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South... | Merit Medical Systems, Inc. | KRA | ||
| Z-0447-2009 | Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly... | Acumed LLC | HSD | ||
| Z-2011-2008 | Keypad replacement for LIFEPAK20 or LIFEPAK20e. This product is an external... | Physio Control, Inc. | LDD | ||
| Z-2010-2008 | Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external... | Physio Control, Inc. | LDD | ||
| Z-2009-2008 | Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external... | Physio Control, Inc. | LDD | ||
| Z-0483-2015 | Class II | Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of... | Beevers Manufacturing & Supply, Inc. | BZD | |
| Z-2468-2012 | Class II | TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This... | Canon Medical Systems USA, Inc. | JAK | |
| Z-2278-2012 | Class II | EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the... | Canon Medical Systems USA, Inc. | LNH | |
| Z-2066-2011 | OB-Link release 2.0.7. distributed by Digisonics, Inc., 3701 Kirby Drive, Houston TX... | Digisonics, Inc | HEM | ||
| Z-2055-2009 | EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC6... | FUJIFILM Healthcare Americas Corporation | ITX | ||
| Z-2054-2009 | EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software... | FUJIFILM Healthcare Americas Corporation | ITX | ||
| Z-2323-2008 | Medtronic Patient programmer, model 37742. The Patient programmer is a hand held... | Medtronic Neuromodulation | LGW | ||
| Z-2322-2008 | Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held... | Medtronic Neuromodulation | EZW | ||
| Z-1857-2008 | Weck, DermaHook", Catalog #382805, 1/2" (12mm) Neuro Elastic Retractors, Sterile, Rx... | Teleflex Medical | GDG | ||
| Z-1856-2008 | Weck, DuraHook", Catalog #382800, 1/4" (6mm) Neuro Elastic Retractors, Sterile, Rx only. | Teleflex Medical | GDG | ||
| Z-1853-2008 | HydraGlide XL Heparin Coated Silicone Thoracic Catheters, Increased number of eyelets... | Atrium Medical Corporation | GBZ | ||
| Z-1852-2008 | HydraGlide XL Heparin Coated Silicone Thoracic Catheters, Increased number of eyelets... | Atrium Medical Corporation | GBZ | ||
| Z-1851-2008 | HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top, Atrium... | Atrium Medical Corporation | GBZ | ||
| Z-1850-2008 | HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top &... | Atrium Medical Corporation | GBZ | ||
| Z-1849-2008 | HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code #... | Atrium Medical Corporation | GBZ | ||
| Z-1848-2008 | HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code #... | Atrium Medical Corporation | GBZ | ||
| Z-1847-2008 | HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code #... | Atrium Medical Corporation | GBZ | ||
| Z-1846-2008 | ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9428, Size (Fr) 28, #... | Atrium Medical Corporation | GBS | ||
| Z-1845-2008 | ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9420, Size (Fr) 20, #... | Atrium Medical Corporation | GBS | ||
| Z-1844-2008 | ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9408, Size (Fr) 8, #... | Atrium Medical Corporation | GBS | ||
| Z-1843-2008 | HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector... | Atrium Medical Corporation | GBS | ||
| Z-1842-2008 | HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector... | Atrium Medical Corporation | GBS |