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-2619-2016 | Class II | Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture... | Cook Incorporated | KGZ | |
| Z-2618-2016 | Class II | Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver... | Cook Incorporated | FCG | |
| Z-2617-2016 | Class II | Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination... | Cook Incorporated | GBL | |
| Z-2616-2016 | Class II | Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for... | Cook Incorporated | DYB | |
| Z-2615-2016 | Class II | FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used... | Cook Incorporated | LFK | |
| Z-2614-2016 | Class II | Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are... | Cook Incorporated | DQO | |
| Z-2613-2016 | Class II | Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended... | Cook Incorporated | DQO | |
| Z-2612-2016 | Class II | Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip... | Cook Incorporated | DQO | |
| Z-2611-2016 | Class II | Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The... | Cook Incorporated | DQO | |
| Z-2610-2016 | Class II | Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic | Cook Incorporated | DQO | |
| Z-1952-2016 | Class II | TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS... | Zimmer Trabecular Metal Technology, Inc. | MBH | |
| Z-2841-2016 | Class II | IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like... | Siemens Healthcare Diagnostics Inc. | CFL | |
| Z-2779-2016 | Class III | VIDAS NT-pro-BNP Product Usage: VIDAS NTproBNP (PBNP) is an automated quantitative test... | bioMerieux, Inc. | NBC | |
| Z-1707-2016 | Class II | GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and... | GE Healthcare | OWB | |
| Z-1706-2016 | Class II | GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and... | GE Healthcare | OWB | |
| Z-1951-2016 | Class II | TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR... | Zimmer Trabecular Metal Technology, Inc. | MBH | |
| Z-1620-2016 | Class II | Given Imaging Bravo pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH... | Medtronic, Inc. | FFT | |
| Z-1619-2016 | Class II | Given Imaging Bravo pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH... | Medtronic, Inc. | FFT | |
| Z-1594-2016 | Class II | CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191... | Eastman Kodak Company | LLZ | |
| Z-1593-2016 | Class II | CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490... | Eastman Kodak Company | LLZ | |
| Z-1950-2016 | Class II | Porous Patella 32Mm X 10Mm - 00587806532 Porous Patella 35Mm X 10Mm... | Zimmer Trabecular Metal Technology, Inc. | MBH | |
| Z-0725-2017 | Class II | Magnesium on RX Imola analyser IVD | Randox Laboratories, Limited | JGJ | |
| Z-2135-2016 | Class II | MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage... | Canon Medical Systems USA, Inc. | LNH | |
| Z-1907-2016 | Class II | Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for... | B Braun Medical Inc | LHI | |
| Z-1906-2016 | Class II | Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product... | B Braun Medical Inc | LHI | |
| Z-1909-2016 | Class III | CytoScan Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers... | Affymetrix Inc | PFX | |
| Z-1601-2016 | Class II | Syngo Dynamics; Kinetdx Picture Archiving and Communications System | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-1688-2016 | Class II | LenSx Laser System. Indicated for use in patients undergoing cataract surgery and... | Alcon Laboratories | OOE | |
| Z-1591-2016 | Class II | Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209... | Biosense Webster Inc | MTD | |
| Z-1590-2016 | Class II | Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203... | Biosense Webster Inc | MTD | |
| Z-1612-2016 | Class II | HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of... | Philips North America LLC | MKJ | |
| Z-2123-2017 | Class II | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI... | Merge Healthcare Incorporated | LLZ | |
| Z-1598-2016 | Class II | MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers... | Siemens Medical Solutions USA, Inc. | LNH | |
| Z-1934-2016 | Class II | Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an... | Siemens Healthcare Diagnostics Inc. | CDT | |
| Z-1933-2016 | Class II | Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a... | Siemens Healthcare Diagnostics Inc. | CHH | |
| Z-1932-2016 | Class II | Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System... | Siemens Healthcare Diagnostics Inc. | KNK | |
| Z-1931-2016 | Class II | Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System... | Siemens Healthcare Diagnostics Inc. | KHP | |
| Z-1930-2016 | Class II | Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System... | Siemens Healthcare Diagnostics Inc. | CDT | |
| Z-1577-2016 | Class I | Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery... | Medtronic, Inc. | CCK | |
| Z-1905-2016 | Class II | Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral... | Exactech, Inc. | MRA | |
| Z-1904-2016 | Class II | Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem... | Exactech, Inc. | MRA | |
| Z-1903-2016 | Class II | Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog... | Exactech, Inc. | MRA | |
| Z-1902-2016 | Class II | Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog... | Exactech, Inc. | MRA | |
| Z-1901-2016 | Class II | Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup)... | Exactech, Inc. | MRA | |
| Z-1900-2016 | Class II | Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup)... | Exactech, Inc. | MRA | |
| Z-1560-2016 | Class II | Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code... | Canon Medical Systems USA, Inc. | JAK | |
| Z-1623-2016 | Class II | Distal Femoral Replacement (patient specific, custom made orthopedic implant device)... | Stanmore Implants Worldwide, Ltd. | JWH | |
| Z-1635-2016 | Class II | CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The... | Stryker Corp. | MBI | |
| Z-1634-2016 | Class II | CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The... | Stryker Corp. | MBI | |
| Z-1807-2025 | Class II | TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and... | Echopixel, Inc. | LLZ |