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-1128-03 | EasyWeb | Philips North America LLC | LLZ | ||
| Z-1223-03 | Easy Access PACS System with software Release 5, 6.2, or 7.2 | Philips North America LLC | LLZ | ||
| Z-0662-03 | Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile... | Medtronic Xomed, Inc. | EQJ | ||
| Z-0462-03 | Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of... | Best Vascular, Inc. | JAJ | ||
| Z-0057-04 | Clinitron At Home Air Fluidized Therapy Unit | Hill-Rom Manufacturing, Inc. | INX | ||
| Z-0779-03 | N/a | 3M Company | FRC | ||
| Z-1181-03 | Zilver Expandable Metal Biliary Stent | Wilson-Cook Medical Inc. | FGE | ||
| Z-1180-03 | Za-Stent Expandable Metal Biliary Stent | Wilson-Cook Medical Inc. | FGE | ||
| Z-1179-03 | Spiral Z Expandable Metal Biliary Stent | Wilson-Cook Medical Inc. | FGE | ||
| Z-0435-05 | B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers... | Abbott Medical | LID | ||
| Z-1133-03 | ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories... | Abbott Medical | JJE | ||
| Z-1031-03 | Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics... | Zeus Scientific LLC | DHR | ||
| Z-0393-05 | Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile... | Teleflex Medical | GDO | ||
| Z-0018-04 | Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal... | Cordis Neurovascular, Inc. | |||
| Z-0843-03 | Aeroset Analyzer, item 9D05-01 | Abbott Medical | JJE | ||
| Z-0739-04 | Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S... | Asahi Kasei Medical MT Corp. Oita Works | KDI | ||
| Z-1147-03 | Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific... | Zeus Scientific LLC | MID | ||
| Z-0951-03 | ESPRIT VENTILATOR, Model V1000 | Respironics, Inc. | CPK | ||
| Z-0903-04 | Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics | Respironics, Inc. | CBK | ||
| Z-1003-03 | ProLong Continuous Nerve Block Set model nubers PL-50 and PL-100 | Life-Tech International, Inc | CAZ | ||
| Z-0961-03 | Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay... | Zeus Scientific LLC | LJB | ||
| Z-1237-03 | Infant reusable blood pressure cuffs, one tube, male slip luer connector, P/N 2930... | GE Medical Systems Information Technologies, Inc. | |||
| Z-0340-05 | Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length 12 Feet (3.7m), Sterile... | Teleflex Medical | FFZ | ||
| Z-1252-06 | SoftPath ASCII Software, used in pathology labs to track and report specimens and... | SCC Soft Computer | JQP | ||
| 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 |