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-0583-2008 | Hill-Rom Affinity Three Birthing Bed, Model P3700A. | Hill-Rom Inc. | KNC | ||
| Z-0582-2008 | Hill-Rom Affinity Two Birthing Bed, Model P3600. | Hill-Rom Inc. | KNC | ||
| Z-0581-2008 | Hill-Rom Affinity Birthing Bed, Model P3600. | Hill-Rom Inc. | KNC | ||
| Z-0674-2009 | Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump, Terumo Cardiovascular... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0945-2008 | Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen... | Boston Scientific Corporation | DQO | ||
| Z-0944-2008 | Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen... | Boston Scientific Corporation | DQO | ||
| Z-0943-2008 | Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen... | Boston Scientific Corporation | DQO | ||
| Z-0942-2008 | Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen... | Boston Scientific Corporation | DQO | ||
| Z-0941-2008 | Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen... | Boston Scientific Corporation | DQO | ||
| Z-0940-2008 | Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen... | Boston Scientific Corporation | DQO | ||
| Z-0939-2008 | Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen... | Boston Scientific Corporation | DQO | ||
| Z-0938-2008 | Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen... | Boston Scientific Corporation | DQO | ||
| Z-0937-2008 | Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen... | Boston Scientific Corporation | DQO | ||
| Z-0936-2008 | Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen... | Boston Scientific Corporation | DQO | ||
| Z-0590-2008 | BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog... | Becton Dickinson & Co | JKA | ||
| Z-0589-2008 | BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder;Catalog Number... | Becton Dickinson & Co | JKA | ||
| Z-0935-2008 | Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen... | Boston Scientific Corporation | DQO | ||
| Z-0454-2008 | BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27 G x 7/8 in), Catalog #/REF #: 585793... | Becton Dickinson & Co | HNM | ||
| Z-0453-2008 | BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in) , Sterile, Catalog #/REF... | Becton Dickinson & Co | HNM | ||
| Z-0947-2008 | HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R... | Baxter Healthcare Renal Div | FKX | ||
| Z-0946-2008 | Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471... | Baxter Healthcare Renal Div | FKX | ||
| Z-0673-2009 | Terumo Advanced Perfusion System 1 Pressure Venous Occluder, Terumo Cardiovascular... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0672-2009 | Terumo Advanced Perfusion System 1 Temperature Monitoring Systems, Terumo Cardiovascular... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0671-2009 | Terumo Advanced Perfusion System 1 Pressure Monitoring Unit, Terumo Cardiovascular... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0670-2009 | Terumo Advanced Perfusion System 1 Air Bubble Detection Module, Terumo Cardiovascular... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0891-2008 | Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number... | Argon Medical Devices, Inc | DQX | ||
| Z-0890-2008 | Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number... | Argon Medical Devices, Inc | DQX | ||
| Z-0889-2008 | Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number... | Argon Medical Devices, Inc | DQX | ||
| Z-0888-2008 | Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number... | Argon Medical Devices, Inc | DQX | ||
| Z-0887-2008 | Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number... | Argon Medical Devices, Inc | DQX | ||
| Z-0886-2008 | Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number... | Argon Medical Devices, Inc | DQX | ||
| Z-0885-2008 | Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number... | Argon Medical Devices, Inc | DQX | ||
| Z-0884-2008 | Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number... | Argon Medical Devices, Inc | DQX | ||
| Z-0883-2008 | Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number... | Argon Medical Devices, Inc | DQX | ||
| Z-0669-2008 | Intuitive brand da Vinci S, 5 mm Instrument Cannula Model/Part Number: 420011-02, Product... | Intuitive Surgical, Inc. | NAY | ||
| Z-0567-2008 | Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon... | Datascope Corp. | DSP | ||
| Z-0882-2008 | Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number... | Argon Medical Devices, Inc | DQX | ||
| Z-0548-2008 | ProTime Microcoagulation System Instrument:Catalogue Number: PROTIMEINT, International... | Accriva Diagnostics, Inc. | GJS | ||
| Z-0547-2008 | ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPST, International... | Accriva Diagnostics, Inc. | GJS | ||
| Z-0546-2008 | ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, International... | Accriva Diagnostics, Inc. | GJS | ||
| Z-2027-2012 | Class II | OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient... | GE Healthcare | OXO | |
| Z-2026-2012 | Class II | OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System... | GE Healthcare | JAA | |
| Z-2025-2012 | Class II | OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an... | GE Healthcare | JAA | |
| Z-0574-2008 | Stryker Disposable StrykeProbe 32cm Spatula Tip, Ref: 250-070-551, Electrosurgical... | Stryker Corp. | GEI | ||
| Z-0699-2008 | Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number... | Arkray Factory USA, Inc. | CGA | ||
| Z-0573-2008 | Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction... | Stryker Corp. | GEI | ||
| Z-0170-2009 | Alpha-Omega Services, Inc. Product No:NFW0001-010 Description: FLEXIGUIDE NEEDLE... | Alpha Omega Services Inc | IWJ | ||
| Z-0169-2009 | Alpha-Omega Services, Inc. Product No:NFW0001-009 Description: FLEXIGUIDE NEEDLE... | Alpha Omega Services Inc | IWJ | ||
| Z-0168-2009 | Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE... | Alpha Omega Services Inc | IWJ | ||
| Z-0167-2009 | Alpha-Omega Services, Inc. Product No: NFV0003-003 Description: NEEDLE, FLEXIGUIDE... | Alpha Omega Services Inc | IWJ |