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-0439-2008 | Excia Cemented Hip Stems, Size 12mm, Part Number: NJ312K, Aesculap Implant Systems, Inc... | Aesculap Inc | LWJ | ||
| Z-0438-2008 | Excia Cemented Hip Stems, Size 11mm, Part Number : NJ311K, Aesculap Implant Systems... | Aesculap Inc | LWJ | ||
| Z-0437-2008 | Excia Cemented Hip Stems, Size 10mm, Part Number: NJ310K, Aesculap Implant Systems, Inc... | Aesculap Inc | LWJ | ||
| Z-0436-2008 | Excia Cemented Hip Stems, Size 9mm, Part Number: NJ309K, Aesculap Implant Systems, Inc... | Aesculap Inc | LWJ | ||
| Z-0257-2008 | Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott... | Abbott Medical | JQP | ||
| Z-0150-2008 | Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions... | Datascope Corp. | MHX | ||
| Z-1184-2008 | Beckman Coulter UniCel Dxl 800 Access Immunoassay System; Part Number: 973100 With... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0128-2008 | Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental... | ZimVie US Corp LLC | NHA | ||
| Z-0660-2008 | Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare... | GE Healthcare | CBR | ||
| Z-0069-2011 | Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2... | SCC Soft Computer | LNX | ||
| Z-0961-2008 | Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number SC-1100 with... | Advanced Bionics LLC | LGW | ||
| Z-0960-2008 | Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with... | Advanced Bionics LLC | LGW | ||
| Z-0483-2008 | StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number... | Globus Medical, Inc. | JWH | ||
| Z-0482-2008 | StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-4-5... | Globus Medical, Inc. | JWH | ||
| Z-0481-2008 | StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-3-5... | Globus Medical, Inc. | JWH | ||
| Z-0480-2008 | StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-2-5... | Globus Medical, Inc. | JWH | ||
| Z-0479-2008 | StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number... | Globus Medical, Inc. | JWH | ||
| Z-0369-2008 | GE Precision 500D Classical Radiographic-Fluoroscopic X-ray System. Model #2289299-2... | GE Healthcare | JAA | ||
| Z-0849-2008 | Nexframe Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL... | Medtronic Image Guided Neurologics, Inc. | HAW | ||
| Z-0152-2008 | Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model... | Intuitive Surgical, Inc. | NAY | ||
| Z-0151-2008 | Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model... | Intuitive Surgical, Inc. | NAY | ||
| Z-0290-2008 | Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical... | Wright Medical Technology Inc | HWR | ||
| Z-1769-2008 | Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0303-2008 | Extron Electronics OEM, CAB, DVI-I to DVI (3ft.); Part #: 43-112-01 (Stryker Part #... | STRYKER Communications, Inc. | GCJ | ||
| Z-0302-2008 | Extron Electronics OEM, CAB, DVI-Male to DVI-Female Cable Assembly (14 inch.); Part #... | STRYKER Communications, Inc. | GCJ | ||
| Z-0359-2008 | ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE... | Acist Medical Systems, Inc. | DXT | ||
| Z-0149-2008 | Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex... | Boston Scientific Corporation | LJT | ||
| Z-0120-2008 | AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model... | Amnisure International, LLC | JJX | ||
| Z-0981-2008 | Siemens Primeview 3i 2.1 medical charged-particle radiation therapy system, Part No... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0980-2008 | Siemens Coherence Therapist 2.1 medical charged-particle radiation therapy system, Part... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0979-2008 | Siemens Primeview 3i 2.0 medical charged-particle radiation therapy system, Part No... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0978-2008 | Siemens Coherence Therapist 2.0 medical charged-particle radiation therapy system, Part... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0977-2008 | Siemens Syngo based WS 3rd Party V&R medical charged-particle radiation therapy system... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0976-2008 | Siemens Impression Therapist 3rd Party V&R medical charged-particle radiation therapy... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0975-2008 | Siemens AG Therapist 3rd Party V&R medical charged-particle radiation therapy system... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0974-2008 | Siemens Primeview 3i medical charged-particle radiation therapy system, Part No: 7341428... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0973-2008 | Siemens Coherence Impression Therapist system, Part No: 7341410, medical charged-particle... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0972-2008 | Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle radiation... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0971-2008 | Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0526-2008 | BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and... | Becton, Dickinson and Company, BD Biosciences | GKI | ||
| Z-0305-2008 | Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software... | Canon Medical Systems USA, Inc. | IYN | ||
| Z-0720-2008 | Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and... | Varian Medical Systems, Inc. | IYE | ||
| Z-1236-2010 | Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in... | Elekta Limited | IWB | ||
| Z-1708-2008 | Toshiba America Medical Systems (TAMS) Aquilion 64 CT system, computed tomography x-ray... | Canon Medical Systems USA, Inc. | JAK | ||
| Z-1707-2008 | Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray... | Canon Medical Systems USA, Inc. | JAK | ||
| Z-2211-2008 | GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System. Model Numbers 5107849... | GE Healthcare | LNH | ||
| Z-2210-2008 | GE 1.5T and 3.0T Signa HDx MR System Model Numbers: 5127452, 2377062-61, and... | GE Healthcare | LNH | ||
| Z-2094-2008 | Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile. The device... | Boston Scientific Corporation | GEI | ||
| Z-2093-2008 | Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/15 cm, sterile. The device... | Boston Scientific Corporation | GEI | ||
| Z-2092-2008 | Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile. The device... | Boston Scientific Corporation | GEI |