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-2789-2011 | ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2745-2011 | HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator... | Medtronic, Inc. | GEI | ||
| Z-2607-2011 | Eon Mini Neurostimulation (IPG) System Model 3788 System is indicated as an aid in the... | Abbott Medical | LGW | ||
| Z-0455-2013 | Class II | Neptune 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult... | Stryker Corp. | JCX | |
| Z-0454-2013 | Class II | Neptune 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult... | Stryker Corp. | JCX | |
| Z-3220-2011 | BD MAX GBS Catalog Number 441772 For In Vitro Diagnostic Use, For use with the BD MAX... | Becton Dickinson & Co | NQX | ||
| Z-3219-2011 | BD MAX RNA Extraction Kit RNA-3, Catalog Number 437506. Kit contains 24/2D barcode sample... | Becton Dickinson & Co | NQX | ||
| Z-3218-2011 | BD MAX DNA Extraction Kit DNA-3 (Swabs in Transport Medium/UTM), Catalog Number 437503... | Becton Dickinson & Co | NQX | ||
| Z-3217-2011 | BD MAX DNA Extraction Kit DNA-2 (Whole Blood) Catalog Number 437502. Kit contains 24/2D... | Becton Dickinson & Co | NQX | ||
| Z-3216-2011 | BD MAX DNA Extraction Kit DNA-1 (Urine/Plasma) Catalog Number 437501. Kit contains 24/2D... | Becton Dickinson & Co | NQX | ||
| Z-3112-2011 | xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular... | Luminex Corporation | NTI | ||
| Z-2879-2011 | Arthrex Reciprocating Saw Attachment Type: V-600SR Distributed by: Arthrex Inc., Naples... | W & H DentalWerk Buermoos GmbH | HWE | ||
| Z-2893-2011 | Clinac Linear Accelerators; Varian Medical Systems, Palo Alto, CA. Radiation Therapy... | Varian Medical Systems, Inc. | IYE | ||
| Z-2753-2011 | Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot... | Kapp Surgical GmbH | NEU | ||
| Z-2611-2011 | Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. The brochure is... | GE Healthcare | DQK | ||
| Z-2709-2011 | Product Brand Name: Versafitcup Double Mobility Liner Inserter Product Generic Name... | Medacta USA, Inc. | MEH | ||
| Z-2667-2011 | LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers... | Biosense Webster Inc | DRF | ||
| Z-2666-2011 | LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers... | Biosense Webster Inc | DRF | ||
| Z-2665-2011 | HALO Catheter with Auto 10 Technology, Part Number D-1160-43-S, Catalog... | Biosense Webster Inc | DRF | ||
| Z-2664-2011 | ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog... | Biosense Webster Inc | DRF | ||
| Z-2962-2011 | Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. The Aspira Peritoneal... | Bard Access Systems, Inc. | FJS | ||
| Z-2961-2011 | Bard Aspira Luer Adapter, Product Code 4991505. The Aspira Peritoneal Drainage system is... | Bard Access Systems, Inc. | FJS | ||
| Z-2960-2011 | Bard Aspira Dressing Kit, Product Code 4991503. The Aspira Peritoneal Drainage system is... | Bard Access Systems, Inc. | FJS | ||
| Z-2959-2011 | Bard Aspira Drainage Kit, Product Code 4991502. The Aspira Peritoneal Drainage system... | Bard Access Systems, Inc. | FJS | ||
| Z-2723-2011 | Pathfinder NXT Closure top driver - short, REF 3566-2, Zimmer Inc., Warsaw, IN Product... | Zimmer GmbH | HXX | ||
| Z-2722-2011 | Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN Product... | Zimmer GmbH | HXX | ||
| Z-2456-2012 | Class II | ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source | Linvatec Corporation | GCT | |
| Z-2455-2012 | Class II | ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source | Linvatec Corporation | GCT | |
| Z-2859-2011 | Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103)... | Mallinckrodt, Inc. | IZQ | ||
| Z-2706-2011 | Brand Name STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single Piece... | Staar Surgical AG | HQL | ||
| Z-2788-2011 | Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Radiotherapy... | Varian Medical Systems, Inc. | MUJ | ||
| Z-2744-2011 | Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar... | Cambridge Endoscopic Devices, Incorporated | GEI | ||
| Z-2743-2011 | Cambridge Endoscopic Autonomy Laparo-Angle 5mm Metzenbaum Scissors with Monopolar... | Cambridge Endoscopic Devices, Incorporated | GEI | ||
| Z-2624-2011 | Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. Product Generic Name... | Integrated Orbital Implants Inc | hpz | ||
| Z-1428-2012 | Panta Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is... | Integra LifeSciences Corporation | HSB | ||
| Z-0033-2012 | Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial... | Isopure Corp | FJP | ||
| Z-2800-2011 | Model 134, WarmAir Convective Warming Device, 115V, Part #86180, Device Listing #D111865... | Gentherm Medical, LLC | DWJ | ||
| Z-2576-2011 | Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number... | Integra LifeSciences Corporation | FMF | ||
| Z-2575-2011 | Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number... | Integra LifeSciences Corporation | FMF | ||
| Z-2766-2011 | TrueBeam Linear Accelerators (aka Trilogy Mx) Varian Medical Systems, Palo Alto... | Varian Medical Systems, Inc. | IYE | ||
| Z-2693-2011 | THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter... | Medical Components, Inc. | MSD | ||
| Z-2540-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2539-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2538-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2537-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2536-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2535-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2534-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2533-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP | ||
| Z-2532-2011 | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No... | Boston Scientific Corporation | NIP |