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-0588-2018 | Class I | Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following... | Medtronic, Inc. | LWS | |
| Z-0587-2018 | Class I | Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a... | Medtronic, Inc. | LWS | |
| Z-0664-2018 | Class III | Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx... | LivaNova USA, Inc. | DWE | |
| Z-0740-2018 | Class I | NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI... | Ventana Medical Systems Inc | NJT | |
| Z-0739-2018 | Class I | ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in... | Ventana Medical Systems Inc | PPM | |
| Z-0738-2018 | Class I | Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic | Ventana Medical Systems Inc | HYJ | |
| Z-0737-2018 | Class I | OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI... | Ventana Medical Systems Inc | NJT | |
| Z-0736-2018 | Class I | OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro... | Ventana Medical Systems Inc | NJT | |
| Z-0735-2018 | Class I | CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI... | Ventana Medical Systems Inc | NJT | |
| Z-0734-2018 | Class I | CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001... | Ventana Medical Systems Inc | NJT | |
| Z-0733-2018 | Class I | ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001... | Ventana Medical Systems Inc | PPM | |
| Z-0732-2018 | Class I | ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in... | Ventana Medical Systems Inc | PPM | |
| Z-0731-2018 | Class I | iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro... | Ventana Medical Systems Inc | NJT | |
| Z-0730-2018 | Class I | ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI... | Ventana Medical Systems Inc | NJT | |
| Z-0729-2018 | Class I | OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in... | Ventana Medical Systems Inc | NJT | |
| Z-0586-2018 | Class I | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the... | Medtronic, Inc. | NIK | |
| Z-0585-2018 | Class I | Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following... | Medtronic, Inc. | LWS | |
| Z-0584-2018 | Class I | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the... | Medtronic, Inc. | NIK | |
| Z-0583-2018 | Class I | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the... | Medtronic, Inc. | NIK | |
| Z-0582-2018 | Class I | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the... | Medtronic, Inc. | NIK | |
| Z-0334-2018 | Class II | DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston... | DeRoyal Industries, Inc. | LRO | |
| Z-1744-2020 | Class II | ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6... | Johnson & Johnson Vision Care, Inc. | MVN | |
| Z-1314-2018 | Class II | Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard Leukocyte Reduction... | Terumo Cardiovascular Systems Corporation | OEZ | |
| Z-2054-2018 | Class II | ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072... | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-2053-2018 | Class II | ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests)... | Siemens Healthcare Diagnostics Inc. | NBC | |
| Z-1206-2018 | Class II | Johnson & Johnson BAND-AID Brand First Aid Products HURT-FREE Wrap (size: 2in) | Kenvue Brands LLC | FQM | |
| Z-1205-2018 | Class II | Johnson & Johnson BAND-AID Brand First Aid Products HURT-FREE Wrap (size: 1in) | Kenvue Brands LLC | FQM | |
| Z-1204-2018 | Class II | Johnson & Johnson BAND-AID Brand First Aid Products SECURE-FLEX Wrap (size: 3in) | Kenvue Brands LLC | FQM | |
| Z-1203-2018 | Class II | Johnson & Johnson BAND-AID Brand First Aid Products SECURE-FLEX Wrap (size: 2in) | Kenvue Brands LLC | FQM | |
| Z-1202-2018 | Class II | COACH Self-Adhering Sports Wrap (size: 3in) | Kenvue Brands LLC | FQM | |
| Z-1201-2018 | Class II | COACH Self-Adhering Sports Wrap (size: 2in) | Kenvue Brands LLC | FQM | |
| Z-1313-2018 | Class II | ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific... | Phadia AB | DHB | |
| Z-1312-2018 | Class II | ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE... | Phadia AB | DHB | |
| Z-1270-2018 | Class II | cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use)... | Roche Diagnostics GmbH | JJE | |
| Z-1269-2018 | Class II | Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete)... | Roche Diagnostics GmbH | JJE | |
| Z-1268-2018 | Class II | c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module... | Roche Diagnostics GmbH | JJE | |
| Z-1542-2018 | Class III | Alere iScreen Dx Urine Drug Screen Card | Ameditech, Inc. | LFH | |
| Z-1300-2018 | Class II | Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN... | DePuy Spine, Inc. | NDN | |
| Z-1194-2018 | Class II | ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 &... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1293-2018 | Class II | Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The... | GE Healthcare | OSP | |
| Z-1292-2018 | Class II | Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product... | GE Healthcare | OSP | |
| Z-0824-2018 | Class II | Camera System, Television, Surgical without audio Intended for transmission and... | Hill-Rom Inc. | FWB | |
| Z-1183-2018 | Class II | Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be... | Ortho-Clinical Diagnostics, Inc. | PSZ | |
| Z-0514-2018 | Class II | Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an... | Philips North America LLC | KPS | |
| Z-0513-2018 | Class II | Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging... | Philips North America LLC | KPS | |
| Z-0512-2018 | Class II | BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras... | Philips North America LLC | KPS | |
| Z-0511-2018 | Class II | BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single... | Philips North America LLC | KPS | |
| Z-0510-2018 | Class II | BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma... | Philips North America LLC | KPS | |
| Z-2229-2018 | Class II | DermaPro Waterproof Silicone Tape, SNS57232 | Safe N Simple, LLC | KGX | |
| Z-1629-2018 | Class II | ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle... | Abbott Medical | JKC |