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-1102-2007 | Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC, a Johnson & Johnson... | Veridex, LLC | NQI | ||
| Z-0847-2007 | Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc... | Merit Medical Systems, Inc. | FMG | ||
| Z-0846-2007 | Custom Kit, Cardiac Cath Kit, Rx only, REF/CAT No.: K09-90240HP, Merit Medical Systems... | Merit Medical Systems, Inc. | FMG | ||
| Z-0845-2007 | Custom 72inch Spike LG Bore Sub, REF/CAT 520016, for use with fluid administration sets... | Merit Medical Systems, Inc. | FMG | ||
| Z-0844-2007 | Luer Male Large Bore, REF/CAT No.: 102100001, for use in fluid administration sets, 40000. | Merit Medical Systems, Inc. | FMG | ||
| Z-0843-2007 | Custom Fluid Administration Set, Rx only, REF/CAT No.: K09-09209CP, Merit Medical... | Merit Medical Systems, Inc. | FMG | ||
| Z-0842-2007 | Aortic Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-0841-2007 | CryoValve, Pulmonary Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-0904-2007 | Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula... | Surge Medical Solutions, LLC | DWF | ||
| Z-0903-2007 | Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula... | Surge Medical Solutions, LLC | DWF | ||
| Z-0902-2007 | Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula... | Surge Medical Solutions, LLC | DWF | ||
| Z-0901-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating... | Surge Medical Solutions, LLC | DWF | ||
| Z-0900-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18mm... | Surge Medical Solutions, LLC | DWF | ||
| Z-0899-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating... | Surge Medical Solutions, LLC | DWF | ||
| Z-0898-2007 | Surge Medical Solutions brand 15 Fr. (5.0mm) Surge Medical Solutions 15 Fr. (5.0mm)... | Surge Medical Solutions, LLC | DWF | ||
| Z-0897-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm... | Surge Medical Solutions, LLC | DWF | ||
| Z-0896-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating... | Surge Medical Solutions, LLC | DWF | ||
| Z-0895-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating... | Surge Medical Solutions, LLC | DWF | ||
| Z-0894-2007 | Surge Medical Solutions Retrograde Cardio. Cannula, 18mm self-inflating textured balloon... | Surge Medical Solutions, LLC | DWF | ||
| Z-0893-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating... | Surge Medical Solutions, LLC | DWF | ||
| Z-0892-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating... | Surge Medical Solutions, LLC | DWF | ||
| Z-1062-2007 | Gebauer''s Pain Ease Sample Spray -Topical Anesthtic Skin Refrigerant is a vapocoolant... | Gebauer Co | MLY | ||
| Z-1061-2007 | Gebauer''s Pain Ease Medium Stream -Topical Anesthetic Skin Refrigerant is a vapocoolant... | Gebauer Co | MLY | ||
| Z-1060-2007 | Gebauer''s Instant Ice Medium Stream - temporary relief and reduction of minor pain and... | Gebauer Co | MLY | ||
| Z-1059-2007 | Gebauer''s Instant Ice Mist- is used like ice for the temporary relief and reduction of... | Gebauer Co | MLY | ||
| Z-1058-2007 | Gebauer''s Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is... | Gebauer Co | MLY | ||
| Z-1057-2007 | Gebauer''s Pain Ease Mist Spray- Topical Anesthetic Skin Refrigerant -is a vapocoolant... | Gebauer Co | MLY | ||
| Z-0949-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 20mm (60... | Conmed Endoscopic Technologies, Inc. | KNQ | ||
| Z-0948-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 18mm (54... | Conmed Endoscopic Technologies, Inc. | KNQ | ||
| Z-0947-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 15mm (45... | Conmed Endoscopic Technologies, Inc. | KNQ | ||
| Z-0946-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 12mm (36... | Conmed Endoscopic Technologies, Inc. | KNQ | ||
| Z-0945-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 10mm (30... | Conmed Endoscopic Technologies, Inc. | KNQ | ||
| Z-0944-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 8mm (24... | Conmed Endoscopic Technologies, Inc. | KNQ | ||
| Z-0943-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 6mm (18... | Conmed Endoscopic Technologies, Inc. | KNQ | ||
| Z-0942-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr)... | Conmed Endoscopic Technologies, Inc. | KNQ | ||
| Z-0941-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr)... | Conmed Endoscopic Technologies, Inc. | KNQ | ||
| Z-0940-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr)... | Conmed Endoscopic Technologies, Inc. | KNQ | ||
| Z-0939-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr)... | Conmed Endoscopic Technologies, Inc. | KNQ | ||
| Z-0938-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr)... | Conmed Endoscopic Technologies, Inc. | KNQ | ||
| Z-0937-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr)... | Conmed Endoscopic Technologies, Inc. | KNQ | ||
| Z-0934-2007 | Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Medtronic, Inc. Minneapolis... | Medtronic Neuromodulation | MHY | ||
| Z-0258-2008 | Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and... | Intuitive Surgical, Inc. | NAY | ||
| Z-2446-2010 | Disposable Detachable Monopolar Needle Electrode for electromyograph model number... | Chalgren Enterprises, Inc. | IKT | ||
| Z-1525-2009 | Stryker Xia Dual Anterior Staple; Non Sterile; Catalog number 03820115; Manufactured... | Howmedica Osteonics Corp | NKB | ||
| Z-1066-2007 | ALFA II Modular Femoral Right Modular Stem Porous Coated (Bowed); Size 6 Right; Length... | Encore Medical, LP | JDI | ||
| Z-1065-2007 | ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length... | Encore Medical, LP | JDI | ||
| Z-1064-2007 | ALFA II Modular Femoral Stem Pourous Coated; Size 7; Length 200mm; Distal Diameter... | Encore Medical, LP | JDI | ||
| Z-1063-2007 | ALFA II Modular Femoral Revision Stem Porous Coated; Size 6; Length: 200mm... | Encore Medical, LP | JDI | ||
| Z-0958-2007 | IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. This reagent system is... | Abbott Diagnostic International, Ltd. | LER | ||
| Z-0889-2007 | Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number... | Boston Scientific Corporation | LJE |