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-0670-2007 | Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System... | Intuitive Surgical, Inc. | NAY | ||
| Z-1313-06 | Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200 | Siemens Healthcare Diagnostics Inc. | DHX | ||
| Z-1158-06 | Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 left, Part No. 71420136 | Smith & Nephew, Inc. | HSX | ||
| Z-1157-06 | Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 right, Part No... | Smith & Nephew, Inc. | HSX | ||
| Z-1099-06 | Weck Hem-o-lok Endo 5 Automatic Clip Applier with Medium Polymer Ligating Clips; Rx... | Teleflex Medical | FZP | ||
| Z-1098-06 | Weck Hem-o-lok XL Polymer Ligating Clips; Rx, sterile, extra large size, non-absorbable... | Teleflex Medical | FZP | ||
| Z-1097-06 | Weck Hem-o-lok L Polymer Ligating Clips; Rx, sterile, large size, non-absorbable polymer... | Teleflex Medical | FZP | ||
| Z-1096-06 | Weck Hem-o-lok ML Polymer Ligating Clips; Rx, sterile, medium large size, non-absorbable... | Teleflex Medical | FZP | ||
| Z-0847-06 | Valve-EV Glaucoma Ultra-Smooth, P/N 6006 | Grace Medical, Inc. | KYF | ||
| Z-0846-06 | Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365V | Grace Medical, Inc. | KYF | ||
| Z-0845-06 | Glaucoma Aqueous Shunt, 209 mm, valved, P/N EG209V | Grace Medical, Inc. | KYF | ||
| Z-0844-06 | Krupin Eye Valve, P/N 6003 | Grace Medical, Inc. | KYF | ||
| Z-0899-06 | Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog... | Roche Diagnostics GmbH | CFR | ||
| Z-0850-06 | K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit... | Kamiya Biomedical Company, LLC | DCK | ||
| Z-0909-06 | Powder Free Latex , Non-sterile Medical Exam Gloves Cat #s: 22401 22402 22403 and 22404 | Gulf South Medical Supply Inc | LYY | ||
| Z-1146-2007 | ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment. | Northwest Medical Physics Equipment, Inc. | IYE | ||
| Z-1453-06 | TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards... | Radiometer America, Inc | KLK | ||
| Z-0828-06 | Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile EO... | Boston Scientific Corporation | NIK | ||
| Z-0827-06 | Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac Resynchronization Therapy... | Boston Scientific Corporation | NIK | ||
| Z-0826-06 | Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac... | Boston Scientific Corporation | NIK | ||
| Z-0825-06 | Guidant CONTAK RENEWAL 3 (models H170,H175) CONTAK RENEWAL 3 HE (models H177, H179)... | Boston Scientific Corporation | NIK | ||
| Z-1305-06 | TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped... | DSM Biomedical, Inc. | NFA | ||
| Z-0852-06 | MD4 X-ray system | Philips North America LLC | JAA | ||
| Z-0851-06 | MD3 X-ray system | Philips North America LLC | JAA | ||
| Z-0839-06 | 24F Tri-Funnel Replacement Gastrostomy Tube | Bard Access Systems, Inc. | KGC | ||
| Z-0838-06 | 22F Tri-Funnel Replacement Gastrostomy Tube | Bard Access Systems, Inc. | KGC | ||
| Z-0837-06 | 20F Tri-Funnel Replacement Gastrostomy Tube | Bard Access Systems, Inc. | KGC | ||
| Z-0836-06 | 18F Tri-Funnel Replacement Gastrostomy Tube | Bard Access Systems, Inc. | KGC | ||
| Z-0785-06 | Button Switch Electrosurgical Pencil with Holster | Megadyne Medical Products, Inc | GEI | ||
| Z-0784-06 | Rocker Switch Electrosurgical Pencil with Holster | Megadyne Medical Products, Inc | GEI | ||
| Z-0783-06 | Button Switch Electrosurgical Pencil with Stainless Steel Tip and Holster | Megadyne Medical Products, Inc | GEI | ||
| Z-0782-06 | Rocker Switch Electrosurgical Pencil with Stainless Steel Tip and Holster | Megadyne Medical Products, Inc | GEI | ||
| Z-0781-06 | Button Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster | Megadyne Medical Products, Inc | GEI | ||
| Z-0780-06 | Rocker Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster | Megadyne Medical Products, Inc | GEI | ||
| Z-0779-06 | Button Switch Electrosurgical Pencil with E-Z Clean Tip and Holster | Megadyne Medical Products, Inc | GEI | ||
| Z-0778-06 | Rocker Switch Electrosurgical Pencil with E-Z Clean Tip | Megadyne Medical Products, Inc | GEI | ||
| Z-1159-06 | Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility... | Medtronic Gastroenterology / Urology | KLA | ||
| Z-1235-06 | KinetDx 4.0 Ultrasound Image Management System. | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0026-2007 | ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed | Extended Care Air Therapy Systems Inc | FNL | ||
| Z-1076-06 | 6F ZUMA SR5.0 Coronary Guiding catheter designed to provide a pathway through which... | Medtronic, Inc. | DQY | ||
| Z-1075-06 | 6F ZUMA SR4.0 CATHETER ZM6SR40 ZM 6F 100CM SR4.0 Coronary Guiding catheter designed to... | Medtronic, Inc. | DQY | ||
| Z-1074-06 | 6F ZUMA SR3.5 CATHETER ZM6SR35 ZM 6F 100CM SR3.5 Coronary Guiding catheter designed to... | Medtronic, Inc. | DQY | ||
| Z-1073-06 | 6F ZUMA SR3.0 CATHETER ZM6SR30 ZM 6F 100CM SR3.0 Coronary Guiding catheter designed to... | Medtronic, Inc. | DQY | ||
| Z-1072-06 | 6F ZUMA SL5.0 CATHETER ZM6SL50 ZM 6F 100CM SL5.0 Coronary Guiding catheter designed... | Medtronic, Inc. | DQY | ||
| Z-1071-06 | 6F ZUMA MAC 4.0 110CM Coronary Guiding catheter designed to provide a pathway through... | Medtronic, Inc. | DQY | ||
| Z-1070-06 | 6F ZUMA MAC 3.5 110CM Coronary Guiding catheter designed to provide a pathway through... | Medtronic, Inc. | DQY | ||
| Z-1069-06 | 6F ZUMA JR5.0 110CM CATHETER ZM61JR50A ZM 6F 110CM JR5.0 Coronary Guiding catheter... | Medtronic, Inc. | DQY | ||
| Z-1068-06 | ZM6JR40A 6F ZUMA JR4.0 110CM CATHETER ZM6JR40A ZM 6F 110CM JR4.0 Coronary Guiding... | Medtronic, Inc. | DQY | ||
| Z-1067-06 | CATH, GUIDE 6F JL6.0 110CM ZUM CATHETER ZM6JL60A ZM 6F 110CM JL60 Coronary Guiding... | Medtronic, Inc. | DQY | ||
| Z-1066-06 | 6F ZUMA JL40 110CM CATHETER ZM6JL40A ZM 6F 110CM JL4.0 Coronary Guiding catheter... | Medtronic, Inc. | DQY |