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-0166-2016 | Class II | Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test... | Wallac Oy | JQP | |
| Z-2786-2015 | Class II | Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular... | Terumo Cardiovascular Systems Corporation | N/A | |
| Z-0121-2016 | Class II | Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect... | DJO, LLC | IMJ | |
| Z-0025-2016 | Class II | Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact... | Integra LifeSciences Corporation | HAW | |
| Z-2818-2015 | Class II | EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time... | OLYMPUS Corporation of the Americas | ODG | |
| Z-2772-2015 | Class II | Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures... | DSM Biomedical, Inc. | KIH | |
| Z-0116-2016 | Class II | Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF... | Concentric Medical, Inc. | DQY | |
| Z-2783-2015 | Class II | ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-2547-2015 | Class II | Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak Preconnect... | Medtronic, Inc. | MKJ | |
| Z-2799-2015 | Class II | Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in... | Resource Optimization & Innovation, LLC | LRO | |
| Z-2798-2015 | Class II | Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in... | Resource Optimization & Innovation, LLC | LRO | |
| Z-2546-2015 | Class II | MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item... | Medtronic, Inc. | DRO | |
| Z-2545-2015 | Class II | MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC | Medtronic, Inc. | DRO | |
| Z-2763-2015 | Class II | CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per... | Medtec LLC | FMQ | |
| Z-1922-2016 | Class II | Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic... | Apatech Ltd. | MQV | |
| Z-0107-2016 | Class II | SOMATOM Force; computed tomography x-ray system. Intended to generate and process... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2800-2015 | Class II | PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim... | Zien Medical Technologies LLC | GDX | |
| Z-2736-2015 | Class II | MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model #... | Medtronic Perfusion Systems | DWE | |
| Z-2735-2015 | Class II | MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the... | Medtronic Perfusion Systems | KDI | |
| Z-2795-2015 | Class II | Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in... | Brainlab, Inc. | HAW | |
| Z-2784-2015 | Class II | Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote... | Abbott Medical | NVZ | |
| Z-2793-2015 | Class II | Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110... | Microtek Medical LLC | LHC | |
| Z-0118-2016 | Class II | CIOS ALPHA; image intensified fluoroscopic x-ray system | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-2734-2015 | Class II | da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General... | Intuitive Surgical, Inc. | NAY | |
| Z-0248-2016 | Class II | Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer... | Maquet Cardiovascular Us Sales, LLC | FWZ | |
| Z-0247-2016 | Class II | Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet... | Maquet Cardiovascular Us Sales, LLC | FWZ | |
| Z-0752-2016 | Class II | INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems | Canon Medical Systems USA, Inc. | OWB | |
| Z-0021-2016 | Class II | SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0020-2016 | Class II | SOMATOM Definition Flash; intended to produce cross-sectional images of the body by... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0019-2016 | Class II | SOMATOM Definition Edge; intended to produce cross-sectional images of the body by... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2540-2015 | Class II | SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla... | Limacorporate S.p.A. | HSD | |
| Z-2539-2015 | Class II | SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR... | Limacorporate S.p.A. | KWT | |
| Z-0161-2016 | Class II | Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access... | Nipro Medical Corporation | LLB | |
| Z-2762-2015 | Class II | XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded... | Revmedx Inc | NAB | |
| Z-2478-2015 | Class III | FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F... | Abbott Electrophysiology | MTD | |
| Z-2438-2015 | Class II | Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock... | Otto Bock Healthcare Products GmbH | ISW | |
| Z-1694-2016 | Class II | Custom Paks containing 23G and 25G valved trocar cannula provide access into the... | Alcon Laboratories | NGY | |
| Z-1693-2016 | Class II | 23G and 25G Constellation Totalplus Paks provides access into the posterior segment of... | Alcon Laboratories | NGY | |
| Z-1692-2016 | Class II | Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the... | Alcon Laboratories | NGY | |
| Z-0027-2016 | Class II | Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are... | Zimmer GmbH | FSM | |
| Z-0106-2016 | Class II | Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-2794-2015 | Class II | Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended... | Synthes (USA) Products LLC | HWC | |
| Z-2470-2015 | Class II | Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0... | GE Healthcare | LLZ | |
| Z-2469-2015 | Class II | Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with... | GE Healthcare | LLZ | |
| Z-2448-2015 | Class II | LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product... | Alcon Laboratories | HRM | |
| Z-0267-2016 | Class II | Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to a surgical... | ZimVie US Corp LLC | NDP | |
| Z-0266-2016 | Class II | Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a... | ZimVie US Corp LLC | NDP | |
| Z-2774-2015 | Class II | CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat... | Advanced Sterilization Products | MED | |
| Z-2758-2015 | Class II | Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model... | Intuitive Surgical, Inc. | NAY | |
| Z-2757-2015 | Class II | Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers... | Intuitive Surgical, Inc. | NAY |