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-2385-2012 | Class II | Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI... | Tedan Surgical Innovations, Inc. | LXH | |
| Z-1209-2013 | Class II | GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE... | GE Healthcare | LNH | |
| Z-1208-2013 | Class II | GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging... | GE Healthcare | LNH | |
| Z-1207-2013 | Class II | GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa... | GE Healthcare | LNH | |
| Z-0464-2013 | Class II | Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee... | Merit Medical Systems, Inc. | LRO | |
| Z-2083-2012 | Class II | NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a... | Neusoft Medical Systems Co., Ltd. | JAK | |
| Z-1944-2012 | Class II | MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image... | Elekta Limited | IYE | |
| Z-2064-2012 | Class I | Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical... | Stryker Corp. | FYD | |
| Z-2063-2012 | Class I | Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management... | Stryker Corp. | FYD | |
| Z-2062-2012 | Class I | Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000... | Stryker Corp. | FYD | |
| Z-2061-2012 | Class I | Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part... | Stryker Corp. | FYD | |
| Z-2283-2012 | Class III | Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and... | Siemens Healthcare Diagnostics Inc. | DAP | |
| Z-2172-2012 | Class II | EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System... | Siemens Healthcare Diagnostics Inc. | NSX | |
| Z-2173-2012 | Class II | Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data... | Siemens Healthcare Diagnostics Inc. | NSX | |
| Z-1823-2012 | Class II | Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1943-2012 | Class III | Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah... | Integra Pain Management | CAZ | |
| Z-1967-2012 | Class II | Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and... | Edwards Lifesciences LLC | DWF | |
| Z-0048-2013 | Class II | Siemens syngo.plaza radiological image processing system. | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-2380-2012 | Class II | Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is... | Zoe Medical, Inc. | MHX | |
| Z-2304-2012 | Class II | ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas... | Sendx Medical, Inc. | CHL | |
| Z-1927-2012 | Class II | AirLife MiniSpacer MDI Dispenser Adapter. Dual-Spray MiniSpacer Metered Dose Inhaler... | Thayer Medical Corportation | CAF | |
| Z-1991-2012 | Class II | Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device... | Olsen Medical | GEI | |
| Z-1990-2012 | Class II | Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use... | Olsen Medical | GEI | |
| Z-1981-2012 | Class II | Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle)... | Zimmer GmbH | NKB | |
| Z-1980-2012 | Class II | Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle)... | Zimmer GmbH | NKB | |
| Z-1933-2012 | Class II | PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during... | Zimmer GmbH | NKB | |
| Z-0805-2013 | Class II | Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and... | Aesculap Inc | JXG | |
| Z-2053-2012 | Class II | Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz)... | Leica Microsystems, Inc. | FSO | |
| Z-1445-2013 | Class II | I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended... | Halyard Health | BSO | |
| Z-1444-2013 | Class II | I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The... | Halyard Health | BSO | |
| Z-0256-2013 | Class II | Sysmex XE-2100C Automated Hematology System; an automated differential cell counter... | Sysmex America, Inc. | GKZ | |
| Z-0255-2013 | Class II | Sysmex XE-5000 Automated Hematology System; an automated differential cell counter... | Sysmex America, Inc. | GKZ | |
| Z-2276-2012 | Class II | CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55%... | Advanced Sterilization Products | MED | |
| Z-0254-2013 | Class II | Sysmex XE-2100 Automated Hematology System; an automated differential cell counter... | Sysmex America, Inc. | GKZ | |
| Z-1999-2012 | Class II | Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating... | Olsen Medical | GEI | |
| Z-1998-2012 | Class II | Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use... | Olsen Medical | GEI | |
| Z-1997-2012 | Class II | Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps... | Olsen Medical | GEI | |
| Z-1996-2012 | Class II | Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use... | Olsen Medical | GEI | |
| Z-1995-2012 | Class II | Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar... | Olsen Medical | GEI | |
| Z-1994-2012 | Class II | Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar... | Olsen Medical | GEI | |
| Z-1810-2012 | Class II | T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a barrier... | Stryker Corp. | FYA | |
| Z-1809-2012 | Class II | T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier... | Stryker Corp. | FYA | |
| Z-2271-2012 | Class II | Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in... | ZimVie US Corp LLC | NHA | |
| Z-2054-2012 | Class II | Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non... | Synthes (USA) Products LLC | MNI | |
| Z-1898-2012 | Class II | Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen... | Salter Labs | CCK | |
| Z-1904-2012 | Class II | ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100... | Abbott Medical | NIG | |
| Z-2273-2012 | Class II | TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The... | Alphatec Spine, Inc. | KWQ | |
| Z-1550-2013 | Class II | IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic... | Idev Technologies, Inc. | FGE | |
| Z-2305-2012 | Class II | syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is... | Siemens Healthcare Diagnostics Inc. | JQP | |
| Z-2311-2012 | Class II | Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF... | Hill-Rom Inc. | FSY |