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-2021-2011 | MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging. | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-0409-2016 | Class II | Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version... | Philips North America LLC | JAK | |
| Z-1205-2012 | Brand Name: TempSpan CMT Temporary Cement, a temporary cement. Part Number: N69CA. The... | Sybron Dental Specialties, Inc. | EMA | ||
| Z-0990-2012 | Flow Tec Nano-Hybrid Flowable Affected Product Syringe Part No. Value Pack Part... | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0989-2012 | Artiste Nano-Hybrid Affected Product. Syringe Part No. Value Pack Part. No... | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0455-2012 | Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product... | Sybron Dental Specialties, Inc. | EMA | ||
| Z-3280-2011 | Dual Blue-Release Adult Walkers - Wheeled, and Blue Release Junior Walkers with 5 inch... | Invacare GmbH | ITJ | ||
| Z-2044-2011 | COULTER HmX Hematology Analyzer with Autoloader Part number: 6605525, 6605526... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2043-2011 | COULTER HmX Hematology Analyzer Part number: 6605522, 6605523, 6605524 The COULTER HmX... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2042-2011 | COULTER LH 500 Series Analyzer Part number: 178832, 178833, 178834 The COULTER LH 500... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2557-2011 | Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog... | Howmedica Osteonics Corp | ISL | ||
| Z-2192-2011 | BD Nokor Admix Needle 16 G x 1 TW (1.6mm x 25mm) REF 305216 Sterile BD, Franklin Lakes... | Becton Dickinson & Co | FMI | ||
| Z-0159-2015 | Class II | Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a... | Terumo Cardiovascular Systems Corporation | OEZ | |
| Z-0158-2015 | Class II | Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The... | Terumo Cardiovascular Systems Corporation | DTR | |
| Z-0157-2015 | Class II | Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item... | Terumo Cardiovascular Systems Corporation | KRI | |
| Z-0156-2015 | Class II | Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item... | Terumo Cardiovascular Systems Corporation | DTR | |
| Z-2170-2011 | Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number... | Siemens Healthcare Diagnostics Inc. | LCP | ||
| Z-1958-2011 | Dental chairs distributed under several brand names such as DCI Equipment; Marus MaxStar... | DCI International, LLC | NRU | ||
| Z-0161-2015 | Class II | Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a... | Terumo Cardiovascular Systems Corporation | DTR | |
| Z-0160-2015 | Class II | Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number... | Terumo Cardiovascular Systems Corporation | DWF | |
| Z-0593-2012 | IV Start Kits Convenience kit for starting IVs. Triad wipes are packaged within the... | Abbott Medical | FPA | ||
| Z-0592-2012 | Orbit and Orbit Micro Subcutaneous infusion set Triad alcohol wipes are co-packaged with... | Abbott Medical | FPA | ||
| Z-2119-2011 | The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and... | Varian Medical Systems, Inc. | IYE | ||
| Z-1894-2011 | BD Beaver XStar Safety 2.5mm Crescent Knife; REF 378234 Crescent blades are used in a... | Becton Dickinson & Co | H--NN | ||
| Z-1847-2011 | BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled... | Becton Dickinson & Co | LON | ||
| Z-1968-2011 | Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource... | Medtronic, Inc. | KMJ | ||
| Z-1870-2011 | Curlin PainSmart IOD Ambulatory Infusion Pump Provides a means for the volumetric... | Zevex, Inc. | FRN | ||
| Z-1869-2011 | Curlin PainSmart Ambulatory Infusion Pump Provides a means for the volumetric delivery... | Zevex, Inc. | FRN | ||
| Z-1868-2011 | Curlin 6000 IOD Ambulatory Infusion Pump Provides a means for the volumetric delivery of... | Zevex, Inc. | FRN | ||
| Z-1867-2011 | Curlin 6000 CMS Ambulatory Infusion Pump Provides a means for the volumetric delivery of... | Zevex, Inc. | FRN | ||
| Z-0336-2012 | 10mm x 2.7mm RibLoc Screw, a component of the RibLoc Rib Fracture Plating System, Model... | Acute Innovations, LLC | HRS | ||
| Z-2661-2011 | 0200086, Triad Alcohol Prep Pads, 100 box 0200432, Alcohol Prep Pads, packaged in the... | Alere San Diego, Inc. | GJS | ||
| Z-2012-2011 | Sarns Flexible Weighted Sucker in X-COATED PUMP & TABLE PACK, catalog number 73067-01... | Terumo Cardiovascular Systems Corporation | GCY | ||
| Z-2011-2011 | Sarns Flexible Weighted Sucker in CUSTOM X-COATED PERFUSION PACK, catalog number... | Terumo Cardiovascular Systems Corporation | GCY | ||
| Z-2010-2011 | Sarns Flexible Weighted Sucker in CUSTOM X-COATED PERFUSION PACK, catalog number... | Terumo Cardiovascular Systems Corporation | GCY | ||
| Z-2009-2011 | Sarns Flexible Weighted Sucker in X-COATED CUSTOM TUBING PACK, catalog number 70932-01... | Terumo Cardiovascular Systems Corporation | GCY | ||
| Z-2008-2011 | Sarns Flexible Weighted Sucker in PUMP & TABLE PACK with PALL (custom pack), catalog... | Terumo Cardiovascular Systems Corporation | GCY | ||
| Z-2007-2011 | Sarns Flexible Weighted Sucker in PUMP & TABLE PACK with PALL (custom pack), catalog... | Terumo Cardiovascular Systems Corporation | GCY | ||
| Z-2006-2011 | Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number... | Terumo Cardiovascular Systems Corporation | GCY | ||
| Z-2005-2011 | Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number... | Terumo Cardiovascular Systems Corporation | GCY | ||
| Z-2004-2011 | Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number... | Terumo Cardiovascular Systems Corporation | GCY | ||
| Z-2003-2011 | Sarns Flexible Weighted Sucker in WI CARDIOVASCULAR PUMP & TABLE PACK (custom pack)... | Terumo Cardiovascular Systems Corporation | GCY | ||
| Z-2002-2011 | Sarns Flexible Weighted Sucker in K9 Pack (custom pack), catalog number 63635-01, Sterile... | Terumo Cardiovascular Systems Corporation | GCY | ||
| Z-2001-2011 | Sarns Flexible Weighted Sucker, Sterile, catalog 804113, Terumo Cardiovascular Systems... | Terumo Cardiovascular Systems Corporation | GCY | ||
| Z-1910-2011 | SPIDER ADVANCED Surgical Platform The SPIDER is a single port, single incision device to... | Asensus Surgical, Inc. | GCJ | ||
| Z-1909-2011 | SPIDER Surgical Platform The SPIDER is a single port, single incision device to... | Asensus Surgical, Inc. | GCJ | ||
| Z-1678-2011 | 2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion | Animas Corp. | LZG | ||
| Z-3262-2011 | ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801105, BALLOON... | Angiodynamics Worldwide Headquarters | DQY | ||
| Z-3261-2011 | ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801101, BALLOON... | Angiodynamics Worldwide Headquarters | DQY | ||
| Z-2046-2011 | Clinac High Energy Medical Linear Accelerator, a Trilogy Radiotherapy Delivery System... | Varian Medical Systems, Inc. | IYE |