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-0116-2011 | Medtronic Secura VR, model D224VRC, and model D234VRC not available in the U.S.. Digital... | Medtronic, Inc. | LWS | ||
| Z-0115-2011 | Medtronic Secura DR, model D224DRG, and model D234DRG not available in the U.S.. Digital... | Medtronic, Inc. | LWS | ||
| Z-0114-2011 | Medtronic Maximo II VR, model D284VRC. Digital single chamber implantable cardioverter... | Medtronic, Inc. | LWS | ||
| Z-0113-2011 | Medtronic Maximo II DR, model D284DRG. Digital dual chamber implantable cardioverter... | Medtronic, Inc. | LWS | ||
| Z-0112-2011 | Medtronic Maximo II CRT-D, model D284TRK. Digital implantable cardioverter defibrillator... | Medtronic, Inc. | NIK | ||
| Z-0111-2011 | Medtronic Consulta CRT-D, model D224TRK and Model D234TRK not available in the US... | Medtronic, Inc. | NIK | ||
| Z-0110-2011 | Medtronic Concerto II CRT-D, model D274TRK and Model D294TRK not available in the US... | Medtronic, Inc. | NIK | ||
| Z-1996-2010 | i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ | Abbott Medical | GJS | ||
| Z-2423-2010 | Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1731-2010 | Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa... | Merit Medical Systems, Inc. | DQO | ||
| Z-2398-2010 | Clinical Chemistry Phosphorus assay | Abbott Medical | CEO | ||
| Z-2136-2010 | Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135720 | Bard Peripheral Vascular Inc | DQY | ||
| Z-2135-2010 | Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135717 | Bard Peripheral Vascular Inc | DQY | ||
| Z-2134-2010 | Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135715 | Bard Peripheral Vascular Inc | DQY | ||
| Z-2133-2010 | Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135712 | Bard Peripheral Vascular Inc | DQY | ||
| Z-2132-2010 | Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135620 | Bard Peripheral Vascular Inc | DQY | ||
| Z-2131-2010 | Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135615 | Bard Peripheral Vascular Inc | DQY | ||
| Z-2130-2010 | Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135612 | Bard Peripheral Vascular Inc | DQY | ||
| Z-2129-2010 | Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135520 | Bard Peripheral Vascular Inc | DQY | ||
| Z-2128-2010 | Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135517 | Bard Peripheral Vascular Inc | DQY | ||
| Z-2127-2010 | Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135515 | Bard Peripheral Vascular Inc | DQY | ||
| Z-2126-2010 | Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135512 | Bard Peripheral Vascular Inc | DQY | ||
| Z-2125-2010 | Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135420 | Bard Peripheral Vascular Inc | DQY | ||
| Z-2124-2010 | Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135417 | Bard Peripheral Vascular Inc | DQY | ||
| Z-2123-2010 | Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135415 | Bard Peripheral Vascular Inc | DQY | ||
| Z-2122-2010 | Bard Dorado Pta Balloon Dilatation Catheters, Product Code # Dr135412 | Bard Peripheral Vascular Inc | DQY | ||
| Z-2236-2010 | Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1... | OLYMPUS Corporation of the Americas | FDI | ||
| Z-0286-2011 | BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. For head, whole... | GE Healthcare | JAK | ||
| Z-0820-2011 | Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S... | MEDLINE INDUSTRIES, LP - Northfield | FAF | ||
| Z-1734-2010 | ANGIODYNAMICS BENEPHIT(TM) CV Infusion System, 35 cm, Targeted Renal Therapy Infusion... | Boston Scientific Corporation | KRA | ||
| Z-1733-2010 | ANGIODYNAMICS BENEPHIT(TM) XT Infusion System, 35 cm, Targeted Renal Therapy Infusion... | Boston Scientific Corporation | KRA | ||
| Z-1917-2010 | Automated External Defibrillator (AED) of brand name "Philips HeartStart HS1 Home"... | Philips North America LLC | MKJ | ||
| Z-1916-2010 | Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite"... | Philips North America LLC | MKJ | ||
| Z-1934-2010 | Constellation Vision System, Model: Constellation T, Catalogue Number: 8065751558 The... | Alcon Laboratories | HQC | ||
| Z-1933-2010 | Constellation Vision System, Model: Constellation L, Catalogue Number: 8065751554 The... | Alcon Laboratories | HQC | ||
| Z-1932-2010 | Constellation Vision System, Model: Constellation X, Catalogue Number: 8065751553 The... | Alcon Laboratories | HQC | ||
| Z-1931-2010 | Constellation Vision System, Model: Constellation B, Catalogue Number: 8065751552 The... | Alcon Laboratories | HQC | ||
| Z-1930-2010 | Constellation Vision System, Model: Constellation LX, Catalogue Number: 8065751551 The... | Alcon Laboratories | HQC | ||
| Z-1929-2010 | Constellation Vision System, Model: Constellation LXT, Catalogue Number: 8065751550 The... | Alcon Laboratories | HQC | ||
| Z-1928-2010 | Constellation Vision System, Model: Constellation LT, Catalogue Number: 8065751549 The... | Alcon Laboratories | HQC | ||
| Z-1927-2010 | Constellation Vision System, Model: Constellation XT, Catalogue Number: 8065751548 The... | Alcon Laboratories | HQC | ||
| Z-1926-2010 | Constellation Vision System, Model: Constellation Tabletop, Catalogue Number... | Alcon Laboratories | HQC | ||
| Z-1925-2010 | Constellation Vision System, Model: Constellation Vision System w/o Laser, Catalogue... | Alcon Laboratories | HQC | ||
| Z-1924-2010 | Constellation Vision System, Model: Constellation Vision System w/Laser, Catalogue... | Alcon Laboratories | HQC | ||
| Z-1803-2010 | The SwitchPoint Infinity 2 (SPI2) and SwitchPoint Element (SPE), an integrated voice... | STRYKER Communications, Inc. | GCJ | ||
| Z-1915-2010 | Automated External Defibrillator (AED) of brand name "Philips HeartStart FRx" (Model... | Philips North America LLC | MKJ | ||
| Z-2171-2010 | IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus... | Abbott Medical | NRP | ||
| Z-0864-2011 | Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer... | Medtronic, Inc. | DQY | ||
| Z-0048-2011 | Smith & Nephew Aimer Endofemoral 4mm Offset (Green) Catalog Number: 72201716F... | Smith & Nephew, Inc. | NBH | ||
| Z-0047-2011 | Smith & Nephew Aimer Endofemoral 4mm Offset (Red) Catalog Number: 72201715F... | Smith & Nephew, Inc. | NBH |