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-0513-2007 | Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-08-0300 Vbeam... | Candela Corporation | GEX | ||
| Z-0512-2007 | Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-00-0300 Vbeam... | Candela Corporation | GEX | ||
| Z-0511-2007 | Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-08-0310 Vbeam... | Candela Corporation | GEX | ||
| Z-0510-2007 | Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam... | Candela Corporation | GEX | ||
| Z-0509-2007 | Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-08-0320 Vbeam... | Candela Corporation | GEX | ||
| Z-0508-2007 | Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-00-0320 Vbeam... | Candela Corporation | GEX | ||
| Z-0545-2007 | Sample Management System software for in vitro diagnostic testing Product # 030102-03 | Siemens Healthcare Diagnostics Inc. | CDD | ||
| Z-0659-2007 | Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410. | Terumo Cardiovascular Systems Corporation | DTW | ||
| Z-0658-2007 | Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000; Catalog No. 16406. | Terumo Cardiovascular Systems Corporation | DTW | ||
| Z-0657-2007 | Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405. | Terumo Cardiovascular Systems Corporation | DTW | ||
| Z-0656-2007 | Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401. | Terumo Cardiovascular Systems Corporation | DTW | ||
| Z-0655-2007 | Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400. | Terumo Cardiovascular Systems Corporation | DTW | ||
| Z-0373-2007 | GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare... | GE Healthcare | LLZ | ||
| Z-1432-2010 | Precise Treatment Table Intended as a universal patient treatment support and... | Elekta Limited | JAI | ||
| Z-0643-2007 | BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc... | bioMerieux, Inc. | MDB | ||
| Z-0427-2007 | OOptix (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is... | Alcon Laboratories | LPM | ||
| Z-1373-2008 | Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber... | BIOTRONIK AG | MRM | ||
| Z-0546-2007 | LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223 | LifeSync Corporation | DRG | ||
| Z-0360-2007 | Bard Composix Kugel Hernia Patch- Large Circle 4.5'' with ePTFE Product Code: 0010204 | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-0359-2007 | Bard Composix Kugel Hernia Patch- Large Oval with ePTFE , 5.4'' x 7.0'' Product Number... | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-0426-2007 | Sara Active Sling - Standard; item KK53210.0 - model KA1210 (with safety); manufactured... | Arjo, Inc. | FSA | ||
| Z-0425-2007 | Sara Active Sling - Wide; item KKX00120.0 - models KA1231 (with safety) and KA1241... | Arjo, Inc. | FSA | ||
| Z-0424-2007 | Sara Active Sling - Narrow; item KKX053850.0 - models KA1230 (with safety) and KA1240... | Arjo, Inc. | FSA | ||
| Z-2678-2014 | Class II | No packaging. The device is a computed tomography scanner. Intended to provide corss... | Philips North America LLC | JAX | |
| Z-0574-2007 | AB5000 Console Circulatory Support System Catalog Number: 0015-0000 | Abiomed, Inc. | DSQ | ||
| Z-0534-2007 | Skytron Infinity Series surgical light with triple lightheads, 8 bulbs in 1 - 30'... | Skytron, LLC | FTD | ||
| Z-0533-2007 | Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30' diameter... | Skytron, LLC | FTD | ||
| Z-0532-2007 | Skytron Infinity Series surgical light with triple lightheads, 5 bulbs in each of 3 - 22'... | Skytron, LLC | FTD | ||
| Z-0531-2007 | Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22' lighthead... | Skytron, LLC | FTD | ||
| Z-0530-2007 | Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22'... | Skytron, LLC | FTD | ||
| Z-0529-2007 | Skytron Infinity Series surgical light, 5 bulbs in 1 - 22' diameter lighthead... | Skytron, LLC | FTD | ||
| Z-0528-2007 | Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3... | Skytron, LLC | FTD | ||
| Z-0527-2007 | Skytron Infinity Series surgical light with dual lightheads, 4 bulbs in each of 2 - 22'... | Skytron, LLC | FTD | ||
| Z-0526-2007 | Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead... | Skytron, LLC | FTD | ||
| Z-0525-2007 | Skytron Infinity Series (also called Astro series) minor surgery light with dual... | Skytron, LLC | FTD | ||
| Z-0524-2007 | Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1... | Skytron, LLC | FTD | ||
| Z-0799-2007 | Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov... | Arjo, Inc. | FSG | ||
| Z-0798-2007 | Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov... | Arjo, Inc. | FSG | ||
| Z-0797-2007 | Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov... | Arjo, Inc. | FSG | ||
| Z-0377-2007 | Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF... | Cook Incorporated | FED | ||
| Z-0796-2007 | Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov... | Arjo, Inc. | FSG | ||
| Z-0695-2007 | Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro... | Gambro Renal Products | KDI | ||
| Z-0573-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3655, Size 55mm... | Wright Medical Technology Inc | KWY | ||
| Z-0572-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3654, Size 54mm... | Wright Medical Technology Inc | KWY | ||
| Z-0571-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3653, Size 53mm... | Wright Medical Technology Inc | KWY | ||
| Z-0570-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3652, Size 52mm... | Wright Medical Technology Inc | KWY | ||
| Z-0569-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3651, Size 51mm... | Wright Medical Technology Inc | KWY | ||
| Z-0568-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3650, Size 50mm... | Wright Medical Technology Inc | KWY | ||
| Z-0567-2007 | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-2241, Size 41mm... | Wright Medical Technology Inc | KWY | ||
| Z-0523-2007 | Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor. | GE Healthcare | DSI |