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-1715-2015 | Class II | EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP... | Advanced Sterilization Products | FEB | |
| Z-1714-2015 | Class II | EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR... | Advanced Sterilization Products | FEB | |
| Z-0018-2016 | Class II | Toshiba Aquilion CT System TSX-303A | Canon Medical Systems USA, Inc. | JAK | |
| Z-0017-2016 | Class II | Toshiba Aquilion CT System TSX-302A | Canon Medical Systems USA, Inc. | JAK | |
| Z-0016-2016 | Class II | Toshiba Aquilion CT System TSX-301C | Canon Medical Systems USA, Inc. | JAK | |
| Z-0015-2016 | Class II | Toshiba Aquilion CT System TSX-301B | Canon Medical Systems USA, Inc. | JAK | |
| Z-0014-2016 | Class II | Toshiba Aquilion CT System TSX-301A | Canon Medical Systems USA, Inc. | JAK | |
| Z-0013-2016 | Class II | Toshiba Aquilion CT System TSX-101A | Canon Medical Systems USA, Inc. | JAK | |
| Z-0005-2016 | Class II | Celesteion PCA-9000A/2 PET/CT System | Canon Medical Systems USA, Inc. | KPS | |
| Z-1839-2015 | Class II | Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical... | Ethicon, Inc | GAL | |
| Z-1679-2015 | Class II | RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-2062-2015 | Class II | 0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement... | Stryker Corp. | FQH | |
| Z-0282-2016 | Class II | BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software... | Brainlab, Inc. | HAW | |
| Z-1753-2015 | Class II | Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding... | Gyrus ACMI, Inc. | GEI | |
| Z-1752-2015 | Class II | Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding... | Gyrus ACMI, Inc. | GEI | |
| Z-1608-2015 | Class II | Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either... | GE Healthcare | MHX | |
| Z-1951-2015 | Class I | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard... | Medtronic, Inc. | JOH | |
| Z-1950-2015 | Class I | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model... | Medtronic, Inc. | JOH | |
| Z-1954-2015 | Class II | Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for... | Viewray Systems, Inc. | IYE | |
| Z-1931-2015 | Class II | Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in... | Roche Diagnostics GmbH | KNK | |
| Z-1930-2015 | Class II | Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of... | Roche Diagnostics GmbH | CDT | |
| Z-1929-2015 | Class II | Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in... | Roche Diagnostics GmbH | JJE | |
| Z-1928-2015 | Class II | LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in... | Roche Diagnostics GmbH | LBR | |
| Z-1927-2015 | Class II | LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended... | Roche Diagnostics GmbH | MRR | |
| Z-1926-2015 | Class II | Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111... | Roche Diagnostics GmbH | CFJ | |
| Z-1925-2015 | Class II | HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800... | Roche Diagnostics GmbH | LBS | |
| Z-1924-2015 | Class II | HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein... | Roche Diagnostics GmbH | LBS | |
| Z-1923-2015 | Class II | Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and... | Roche Diagnostics GmbH | JFY | |
| Z-1922-2015 | Class II | Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative... | Roche Diagnostics GmbH | JJE | |
| Z-1921-2015 | Class II | Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in... | Roche Diagnostics GmbH | CHH | |
| Z-1920-2015 | Class II | Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi... | Roche Diagnostics GmbH | CHH | |
| Z-1938-2015 | Class II | EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N | Atrium Medical Corporation | PAD | |
| Z-1937-2015 | Class II | Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100 | Atrium Medical Corporation | PAD | |
| Z-1936-2015 | Class II | Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100 | Atrium Medical Corporation | PAD | |
| Z-1935-2015 | Class II | Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000 | Atrium Medical Corporation | PAD | |
| Z-1843-2015 | Class II | IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test)... | Siemens Healthcare Diagnostics Inc. | DHB | |
| Z-1739-2015 | Class II | R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STERILE... | Smith & Nephew, Inc. | KWZ | |
| Z-1738-2015 | Class II | R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO... | Smith & Nephew, Inc. | KWZ | |
| Z-1737-2015 | Class II | R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE... | Smith & Nephew, Inc. | KWZ | |
| Z-1736-2015 | Class II | R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE... | Smith & Nephew, Inc. | KWZ | |
| Z-1735-2015 | Class II | R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE... | Smith & Nephew, Inc. | KWZ | |
| Z-1676-2015 | Class III | D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product... | Biocare Medical LLC | NJT | |
| Z-1704-2015 | Class II | syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology... | Siemens Medical Solutions USA, Inc. | LMD | |
| Z-1828-2015 | Class II | Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the... | Terumo Cardiovascular Systems Corporation | DTL | |
| Z-1707-2015 | Class III | VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device... | Ortho-Clinical Diagnostics, Inc. | CDP | |
| Z-1724-2015 | Class II | enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1962-2015 | Class II | The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood... | Siemens Healthcare Diagnostics Inc. | CGA | |
| Z-1961-2015 | Class II | The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood... | Siemens Healthcare Diagnostics Inc. | CGA | |
| Z-1794-2015 | Class II | Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number... | Medtronic Navigation, Inc | HAW | |
| Z-1958-2015 | Class II | Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of... | Siemens Medical Solutions USA, Inc. | OWB |