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-1209-2017 | Class II | Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use... | Atrium Medical Corporation | KDQ | |
| Z-0987-2017 | Class II | Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy... | Elekta Limited | MUJ | |
| Z-1386-2017 | Class II | CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is... | Datascope Corp. | DSP | |
| Z-1208-2017 | Class II | Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference... | Atrium Medical Corporation | CAC | |
| Z-1207-2017 | Class II | Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference... | Atrium Medical Corporation | CAC | |
| Z-1206-2017 | Class II | Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended... | Atrium Medical Corporation | KDQ | |
| Z-1205-2017 | Class II | Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended... | Atrium Medical Corporation | KDQ | |
| Z-2652-2017 | Class II | IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical... | AGFA Healthcare Corp. | LLZ | |
| Z-1245-2017 | Class II | Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is... | Tosoh Bioscience Inc | PQQ | |
| Z-1411-2017 | Class II | MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery. | Mako Surgical Corp. | OLO | |
| Z-1113-2017 | Class II | Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set. | FLOWER ORTHOPEDICS Corporation dba Conventus Flower | LXH | |
| Z-2735-2017 | Class II | Agfa Healthcare NX 3.0.8950 Imaging Processing Software | AGFA Healthcare Corp. | MQB | |
| Z-1120-2017 | Class II | IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN... | Siemens Healthcare Diagnostics Inc. | MTF | |
| Z-1119-2017 | Class II | IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN... | Siemens Healthcare Diagnostics Inc. | MTF | |
| Z-1040-2017 | Class III | AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-1029-2017 | Class II | Fresenius 2008K@home Series : Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1028-2017 | Class II | Fresenius 2008K2 Series : Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1027-2017 | Class II | Fresenius 2008K Series : Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1026-2017 | Class II | Fresenius 2008T Series Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1009-2017 | Class II | Monaco RTP System Product Usage: Used to make treatment plans for patients with... | Elekta Limited | MUJ | |
| Z-1102-2017 | Class III | DELFIA PC with V3.0 Software, Fluorometer, for clinical use Product Number... | Revvity Health Sciences, Inc. | KHO | |
| Z-1101-2017 | Class III | Program Update Package AutoDELFIA 3.0, Fluorometer, for clinical use Product Number... | Revvity Health Sciences, Inc. | KHO | |
| Z-1100-2017 | Class III | AutoDELFIA Plate Processor , Fluorometer, for clinical use Product Number... | Revvity Health Sciences, Inc. | KHO | |
| Z-1440-2017 | Class II | Eclipse Hypodermic Needle | Becton Dickinson & Co | FMI | |
| Z-1099-2017 | Class II | Accu-Chek Connect Diabetes Management App | Roche Diabetes Care, Inc. | NDC | |
| Z-1117-2017 | Class II | VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+... | Ortho-Clinical Diagnostics, Inc. | JGS | |
| Z-1103-2017 | Class I | Comprehensive Reverse Shoulder System Humeral Tray Model 115340 | Zimmer GmbH | PAO | |
| Z-0954-2017 | Class II | NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW Plating System is intended... | In2Bones SAS | HRS | |
| Z-0953-2017 | Class II | NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130... | In2Bones SAS | HRS | |
| Z-0952-2017 | Class II | SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit... | In2Bones SAS | HRS | |
| Z-1014-2017 | Class II | DxH 600 Coulter Cellular Analysis System, Catalog No. B23858 | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-1013-2017 | Class II | UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802... | Siemens Healthcare Diagnostics Inc. | GKZ | |
| Z-0975-2017 | Class II | The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and... | GE Healthcare | OXO | |
| Z-0974-2017 | Class II | OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is... | GE Healthcare | OXO | |
| Z-0973-2017 | Class II | OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic... | GE Healthcare | OWB | |
| Z-0986-2017 | Class II | SafeStep Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as... | Bard Access Systems, Inc. | FPA | |
| Z-0985-2017 | Class II | MiniLoc Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75... | Bard Access Systems, Inc. | FPA | |
| Z-1025-2017 | Class II | Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings... | Zimmer GmbH | LPH | |
| Z-1024-2017 | Class II | RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size... | Zimmer GmbH | LPH | |
| Z-1399-2017 | Class II | Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with... | Parker Medical | CBI | |
| Z-1045-2017 | Class II | Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number... | DICOM Grid (dba Ambra Health) | LLZ | |
| Z-1141-2017 | Class II | Dimension Vista Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in... | Siemens Healthcare Diagnostics Inc. | JIF | |
| Z-1140-2017 | Class II | Dimension Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro... | Siemens Healthcare Diagnostics Inc. | JIF | |
| Z-1122-2017 | Class II | MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy | Mevion Medical Systems, Inc. | LHN | |
| Z-1114-2017 | Class II | Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained... | Zimmer GmbH | KRO | |
| Z-1125-2017 | Class II | Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor Forehead... | Medtronic, Inc. | DQA | |
| Z-1006-2017 | Class II | IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a... | Philips North America LLC | JAK | |
| Z-1056-2017 | Class II | APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment... | Baxter Healthcare Corporation | FKX | |
| Z-2645-2017 | Class II | Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast... | Boston Scientific Corporation | DQO | |
| Z-1219-2017 | Class II | Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No... | Zimmer GmbH | JWH |