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-1876-2008 | Straumann Handpiece Driver for RN Solid Abutment 6 L 26.0mm,Stainless Steel -- Reference... | Straumann USA, LLC | DZE | ||
| Z-1875-2008 | VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD); Six Dip... | Sun Biomedical Laboratories, Inc. | DJR | ||
| Z-1874-2008 | VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test... | Sun Biomedical Laboratories, Inc. | JXN | ||
| Z-1873-2008 | VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by... | Sun Biomedical Laboratories, Inc. | DJR | ||
| Z-0296-2009 | Terumo Sarns Level Sensor II (red) (Part # 195274) alarm level sensor transducer for use... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0295-2009 | Terumo Sarns Level Sensor II (yellow) (Part # 195215) alert level sensor transducer for... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0033-2009 | Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V... | Zimmer GmbH | JDC | ||
| Z-0032-2009 | Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V... | Zimmer GmbH | JDC | ||
| Z-2355-2008 | HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, tests... | Hach Company | FKP | ||
| Z-2354-2008 | RPC E-Z Chek Sensitive Total Chlorine and Chloramines Test Strips, Tests Water for Total... | Hach Company | FKP | ||
| Z-2353-2008 | HACH SteriChek Sensitive Total Chlorine Reagent Strips, Tests for water and rinse water... | Hach Company | FKP | ||
| Z-2352-2008 | HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Tests... | Hach Company | FKP | ||
| Z-2160-2008 | General X-Ray System types with Digital Spot Imaging (DSI) software | Philips North America LLC | IZJ | ||
| Z-2231-2008 | ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and... | Abbott Medical | CGZ | ||
| Z-0297-2009 | AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02) The AxSYM Digoxin II... | Abbott Diagnostic International, Ltd. | KXT | ||
| Z-0906-2009 | Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL... | Biomet Microfixation | EMG | ||
| Z-2241-2008 | Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at... | Medtronic Neuromodulation | GZB | ||
| Z-2194-2008 | Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical Systems, Palo... | Varian Medical Systems, Inc. | IYE | ||
| Z-1870-2008 | Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS... | Medacta USA, Inc. | FWX | ||
| Z-2106-2008 | Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc... | Hansen Medical, Inc. | DRA | ||
| Z-2090-2008 | COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in... | Siemens Healthcare Diagnostics Inc. | LTJ | ||
| Z-0110-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5... | Boston Scientific Corporation | NTE | ||
| Z-0109-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5... | Boston Scientific Corporation | NTE | ||
| Z-0108-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5... | Boston Scientific Corporation | NTE | ||
| Z-0107-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5... | Boston Scientific Corporation | NTE | ||
| Z-0106-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5... | Boston Scientific Corporation | NTE | ||
| Z-0105-2009 | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5... | Boston Scientific Corporation | NTE | ||
| Z-2224-2008 | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3957, SIZE 6F x... | Applied Medical Resources Corp | FAD | ||
| Z-2223-2008 | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: BS123, SIZE 6F... | Applied Medical Resources Corp | FAD | ||
| Z-2222-2008 | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3827, SIZE 6F... | Applied Medical Resources Corp | FAD | ||
| Z-2221-2008 | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3855, SIZE 6F x... | Applied Medical Resources Corp | FAD | ||
| Z-2220-2008 | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3857, SIZE 6F x... | Applied Medical Resources Corp | FAD | ||
| Z-2219-2008 | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3856, SIZE 6F x... | Applied Medical Resources Corp | FAD | ||
| Z-2218-2008 | Dynasty Trial Shell 68mm OD, Group H, REF 3300-GH68, Rx only, Non-Sterile, 1 each, Wright... | Wright Medical Technology Inc | LXH | ||
| Z-2217-2008 | Dynasty Trial Shell 66mm OD, Group H, REF 3300-GH66, Rx only, Non-Sterile, 1 each, Wright... | Wright Medical Technology Inc | LXH | ||
| Z-2216-2008 | Dynasty Trial Shell 64mm OD, Group H, REF 3300-GH64, Rx only, Non-Sterile, 1 each, Wright... | Wright Medical Technology Inc | LXH | ||
| Z-2215-2008 | Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only, Non-Sterile, 1 each, Wright... | Wright Medical Technology Inc | LXH | ||
| Z-2227-2008 | Panda iRes and Giraffe Infant Warmers, labeled in part*** GE Healthcare 8880 Gorman Road... | GE Healthcare | FMT | ||
| Z-1522-2008 | GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System | GE Healthcare | MQB | ||
| Z-1521-2008 | GE Healthcare Innova 3100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System) | GE Healthcare | MQB | ||
| Z-0102-2012 | "***REF S-6AC***6 mm Fluted Acorn. Use with SHORT Attachments. ***ANSPACH***Sterile... | The Anspach Effort, Inc. | HTT | ||
| Z-0101-2012 | "***REF S-35DC***3.5 mm Coarse Diamond Ball, Extended Length. Use with SHORT... | The Anspach Effort, Inc. | HTT | ||
| Z-0100-2012 | "***REF A-CRN***1.85 mm x 16 mm Fluted Router. Use with CRANI-A... | The Anspach Effort, Inc. | HTT | ||
| Z-0099-2012 | "***REF L-CRN***2.5 mm x 25.4 mm Fluted Router. Use with CRANI-L... | The Anspach Effort, Inc. | HTT | ||
| Z-0098-2012 | "***REF TURQ-L5***5 mm Fluted Ball. Use with B-TURQ-L Attachment. ***ANSPACH***Sterile... | The Anspach Effort, Inc. | HTT | ||
| Z-0097-2012 | '***REF SIL-3-10***1.93 mm Suture Pass Drill/ 1.17 eye. Use with B-SILVER... | The Anspach Effort, Inc. | HTT | ||
| Z-0096-2012 | "***REF LHD-6B-M***6 mm Fluted Ball. Use with LONG-HD Attachment. ***ANSPACH***Sterile... | The Anspach Effort, Inc. | HTT | ||
| Z-0095-2012 | "***REF GRE-1***1.85 mm x 16 mm Fluted Router. Use with B-GREEN... | The Anspach Effort, Inc. | HTT | ||
| Z-0094-2012 | "***REF BLU-LS9-5E***4.7 mm x 20 mm Fluted Drum, Side Cut Only. Use with B-BLUE-S... | The Anspach Effort, Inc. | HTT | ||
| Z-0093-2012 | "***REF BLU-39***5 mm Fluted Acorn. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile... | The Anspach Effort, Inc. | HTT |