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-1142-03 | Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division... | Abbott Medical | JJE | ||
| Z-0015-04 | Critikon brand Omni-Sat Adult, Semi-Disposable Sensor - P/N 009136 | GE Medical Systems Information Technologies, Inc. | |||
| Z-0014-04 | Critikon brand Omni-Sat Neonatal, Semi-Disposable Sensor, P/N 009130 | GE Medical Systems Information Technologies, Inc. | |||
| Z-0013-04 | Critikon brand Omni-Stat Finger Sensor - P/N 009084 | GE Medical Systems Information Technologies, Inc. | |||
| Z-1236-03 | Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association... | GE Medical Systems Information Technologies, Inc. | |||
| Z-0384-05 | Ultrasound Probe Drape Tapered to 1.5' Sterile 8' x 60', Product Number 781-983... | Hydro-Med Products, Inc. | MMP | ||
| Z-1693-2008 | iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston... | Boston Scientific Corporation | IYO | ||
| Z-0752-03 | TransportAir Auxiliary Blower Unit. | KCI USA, Inc. | IOQ | ||
| Z-0751-03 | PediDyne AC-Powered Adjustable Hospital Beds | KCI USA, Inc. | IOQ | ||
| Z-0750-03 | BariAir AC-Powered Adjustable Hospital Beds | KCI USA, Inc. | IOQ | ||
| Z-0749-03 | KinAir IV TheraPulse II AC-Powered Adjustable Hospital Beds | KCI USA, Inc. | IOQ | ||
| Z-0748-03 | TriaDyne I and TriaDyne II Powered Adjustable Hospital Beds | KCI USA, Inc. | IOQ | ||
| Z-1065-03 | Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for... | Zeus Scientific LLC | LFX | ||
| Z-0414-03 | KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed... | KCI USA, Inc. | FNL | ||
| Z-0718-03 | TransportAir, Accessory to an Air Bed, Auxiliary Blower Unit, manufactured by Kinetic... | KCI USA, Inc. | INX | ||
| Z-0911-2011 | Varian Medical Systems, Eclipse Client software versions with build numbers from 7.3.10... | Varian Medical Systems, Inc. | MUJ | ||
| Z-0993-2014 | Class II | Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that... | The Standing Company | IPL | |
| Z-0493-2014 | Class II | G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000 | Zimmer GmbH | JWH | |
| Z-0536-2014 | Class II | MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated... | Roche Diagnostics GmbH | JJH | |
| Z-0709-2014 | Class II | King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King... | King Systems Corporation. | CAE | |
| Z-0139-2014 | Class II | Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive... | Intuitive Surgical, Inc. | NAY | |
| Z-0002-2014 | Class II | King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in... | King Systems Corporation. | CAE | |
| Z-1813-2013 | Class II | Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) | HeartWare, Inc. | DSQ | |
| Z-1423-2013 | Class II | BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic... | Becton Dickinson & Co | JTO | |
| Z-1422-2013 | Class II | BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid... | Becton Dickinson & Co | JTO | |
| Z-1324-2013 | Class II | Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate... | Varian Medical Systems, Inc. | JAQ | |
| Z-1044-2013 | Class II | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1043-2013 | Class II | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1042-2013 | Class II | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1041-2013 | Class II | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1040-2013 | Class II | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1039-2013 | Class II | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1038-2013 | Class II | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1037-2013 | Class II | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1036-2013 | Class II | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-0660-2013 | Class II | PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile... | Zimmer GmbH | KWS |