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-2606-2018 | Class II | 119" Blood Set w/200 Micron Filter, Clave, Rotating Luer, Sterile The blood tubing... | Abbott Medical | FMG | |
| Z-0703-2018 | Class II | Foot Controls impacted for the following devices: OAKWORKS Medical CFPM 300 Imaging... | Oakworks Inc | IXR | |
| Z-0634-2018 | Class II | Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated... | Cook Incorporated | FOZ | |
| Z-0633-2018 | Class II | Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier... | Cook Incorporated | FOZ | |
| Z-0632-2018 | Class II | Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog... | Cook Incorporated | FOZ | |
| Z-0631-2018 | Class II | Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier... | Cook Incorporated | FOZ | |
| Z-0630-2018 | Class II | Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier... | Cook Incorporated | FOZ | |
| Z-0720-2018 | Class II | ADVIA Centaur T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | CDP | |
| Z-0675-2018 | Class II | Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001 | Roche Diagnostics GmbH | JJE | |
| Z-0509-2018 | Class II | AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be... | Brainlab, Inc. | JAK | |
| Z-3226-2017 | Class II | Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx... | C.R. Bard Inc | MJC | |
| Z-3046-2017 | Class II | Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile... | Medtronic, Inc. | KKK | |
| Z-0262-2018 | Class II | Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351... | Nxthera, Inc. | KNS | |
| Z-2180-2018 | Class II | Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number... | Datascope Corp. | DWE | |
| Z-2179-2018 | Class II | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number... | Datascope Corp. | DWE | |
| Z-2178-2018 | Class II | Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number... | Datascope Corp. | DWE | |
| Z-0613-2018 | Class II | A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH... | Zimmer Surgical SA | KCY | |
| Z-0612-2018 | Class II | A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by... | Zimmer Surgical SA | KCY | |
| Z-0485-2018 | Class II | Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use... | Baxter Healthcare Corporation | KPE | |
| Z-0025-2018 | Class II | VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled... | Medtronic Navigation, Inc | GEX | |
| Z-0010-2018 | Class II | iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging... | Optovue Inc. | HLI | |
| Z-0009-2018 | Class II | iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high... | Optovue Inc. | HKI | |
| Z-0008-2018 | Class II | iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue... | Optovue Inc. | HLI | |
| Z-0907-2018 | Class II | Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are... | Synthes (USA) Products LLC | HTO | |
| Z-0906-2018 | Class II | 2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are... | Synthes (USA) Products LLC | HTO | |
| Z-0905-2018 | Class II | 2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods... | Synthes (USA) Products LLC | HTO | |
| Z-0904-2018 | Class II | 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number... | Synthes (USA) Products LLC | HTO | |
| Z-0903-2018 | Class II | 2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are... | Synthes (USA) Products LLC | HTO | |
| Z-0902-2018 | Class II | 2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number... | Synthes (USA) Products LLC | HTO | |
| Z-0901-2018 | Class II | 2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are... | Synthes (USA) Products LLC | HTO | |
| Z-0849-2018 | Class II | Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal... | Depuy Orthopaedics Inc. | LXH | |
| Z-0848-2018 | Class II | Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems... | Depuy Orthopaedics Inc. | MAX | |
| Z-0417-2018 | Class II | 9x15" Medium Utility Positioner with Cover | Molnlycke Health Care | OUW | |
| Z-0416-2018 | Class II | 7x10" Small Utility Positioner with Cover | Molnlycke Health Care | OUW | |
| Z-0602-2018 | Class II | ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-0601-2018 | Class II | ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-0405-2018 | Class II | Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication... | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-2897-2018 | Class II | Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue... | Richard Wolf GmbH | HRX | |
| Z-0663-2018 | Class II | NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the... | Zimmer Orthopedic Mfg Ltd | NJL | |
| Z-0682-2018 | Class II | 3-Way Standardbore Stopcock. Product Code: AMS-100. | Vygon Mfg | FMG | |
| Z-0681-2018 | Class II | 19Ga x 1 Huber Needle Set. Product Code: MBS-1910. | Vygon Mfg | FMI | |
| Z-0680-2018 | Class II | CVC Tray Pediatrics. Product Code: AMS-9335CP-2. | Vygon Mfg | LJS | |
| Z-0679-2018 | Class II | 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034. | Vygon Mfg | FPA | |
| Z-0678-2018 | Class II | Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M | Vygon Mfg | FPA | |
| Z-0600-2018 | Class II | Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI... | ConforMIS, Inc. | JWH | |
| Z-3233-2017 | Class II | Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable... | Corcym Inc. | NIK | |
| Z-3232-2017 | Class II | Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable... | Corcym Inc. | MRM | |
| Z-3231-2017 | Class II | Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable... | Corcym Inc. | MRM | |
| Z-3230-2017 | Class II | Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable... | Corcym Inc. | NIK | |
| Z-3229-2017 | Class II | Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable... | Corcym Inc. | MRM |