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-1962-2014 | Class II | ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-2694-2014 | Class II | eye-pak 7407 Tray Support Cover REF 8065740745 | Alcon Laboratories | HMT | |
| Z-2084-2014 | Class II | RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM... | Depuy Orthopaedics Inc. | KWA | |
| Z-2083-2014 | Class II | RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve... | Depuy Orthopaedics Inc. | KWA | |
| Z-1979-2014 | Class II | CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For... | Nihon Kohden America Inc | MHX | |
| Z-1844-2014 | Class II | Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended... | Medtronic, Inc. | CBK | |
| Z-2082-2014 | Class II | RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical... | Depuy Orthopaedics Inc. | KWA | |
| Z-2171-2014 | Class II | EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45... | Intuitive Surgical, Inc. | NAY | |
| Z-2049-2014 | Class II | SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation... | Smith & Nephew, Inc. | MBI | |
| Z-2048-2014 | Class II | SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code... | Smith & Nephew, Inc. | MBI | |
| Z-2047-2014 | Class II | SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation... | Smith & Nephew, Inc. | MBI | |
| Z-2046-2014 | Class II | SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code... | Smith & Nephew, Inc. | MBI | |
| Z-2045-2014 | Class II | SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code... | Smith & Nephew, Inc. | MBI | |
| Z-1927-2014 | Class II | Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-1825-2014 | Class II | RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use | Proteor USA | ISW | |
| Z-1990-2014 | Class II | MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access... | Siemens Healthcare Diagnostics Inc. | LRG | |
| Z-2730-2014 | Class II | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization... | Instrumed International Inc dba Avalign German Specialty Instruments | GEI | |
| Z-2729-2014 | Class II | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization... | Instrumed International Inc dba Avalign German Specialty Instruments | GEI | |
| Z-2728-2014 | Class II | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization... | Instrumed International Inc dba Avalign German Specialty Instruments | GEI | |
| Z-2727-2014 | Class II | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization... | Instrumed International Inc dba Avalign German Specialty Instruments | GEI | |
| Z-2726-2014 | Class II | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization... | Instrumed International Inc dba Avalign German Specialty Instruments | GEI | |
| Z-2725-2014 | Class II | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization... | Instrumed International Inc dba Avalign German Specialty Instruments | GEI | |
| Z-2724-2014 | Class II | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization... | Instrumed International Inc dba Avalign German Specialty Instruments | GEI | |
| Z-2723-2014 | Class II | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization... | Instrumed International Inc dba Avalign German Specialty Instruments | GEI | |
| Z-2722-2014 | Class II | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization... | Instrumed International Inc dba Avalign German Specialty Instruments | GEI | |
| Z-2721-2014 | Class II | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization... | Instrumed International Inc dba Avalign German Specialty Instruments | GEI | |
| Z-1991-2014 | Class II | ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708... | Siemens Healthcare Diagnostics Inc. | MMI | |
| Z-1928-2014 | Class III | Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay... | Alere San Diego, Inc. | NBC | |
| Z-2137-2014 | Class II | KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937... | Eastman Kodak Company | KPR | |
| Z-2022-2014 | Class II | STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and... | B Braun Medical Inc | FPA | |
| Z-2087-2014 | Class II | Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate... | Synthes GmbH | LXH | |
| Z-1728-2014 | Class II | Horizon Medical Imaging Horizon Medical Imaging is a medical image and information... | Change Healthcare Canada Company | LLZ | |
| Z-1807-2014 | Class II | iGUIDE System Product Usage: The intended use of the device is the control of accurate... | Elekta Limited | IYE | |
| Z-1788-2014 | Class II | Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The... | Kerr Corporation | EJJ | |
| Z-1869-2014 | Class II | MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment... | Elekta Limited | IYE | |
| Z-2051-2014 | Class II | Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and... | Shape Medical Systems, Inc | BTY | |
| Z-2001-2014 | Class II | VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is... | Vascular Technology Incorporated | DPW | |
| Z-2000-2014 | Class II | 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is... | Vascular Technology Incorporated | DPW | |
| Z-1999-2014 | Class II | 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended... | Vascular Technology Incorporated | DPW | |
| Z-1998-2014 | Class II | 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended... | Vascular Technology Incorporated | DPW | |
| Z-2174-2014 | Class II | Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-2192-2014 | Class I | Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support... | Childrens Medical Ventures, LLC | FMP | |
| Z-1823-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... | Confluent Medical Technologies, Inc | DQX | |
| Z-1822-2014 | Class I | HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM... | Confluent Medical Technologies, Inc | DQX | |
| Z-1821-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... | Confluent Medical Technologies, Inc | DQX | |
| Z-1820-2014 | Class I | HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating... | Confluent Medical Technologies, Inc | DQX | |
| Z-1819-2014 | Class I | HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating... | Confluent Medical Technologies, Inc | DQX | |
| Z-1818-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... | Confluent Medical Technologies, Inc | DQX | |
| Z-1817-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... | Confluent Medical Technologies, Inc | DQX | |
| Z-1816-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating... | Confluent Medical Technologies, Inc | DQX |