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-0723-04 | TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics... | Abbott Medical | JFT | ||
| Z-1027-04 | DL 2000 Data Manager, Software Version 6.2 | Siemens Healthcare Diagnostics Inc. | |||
| Z-0729-04 | Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011 | Boston Scientific Corporation | DQO | ||
| Z-0637-04 | Cytomics RXP Software, Version 1.0, Part Numbers: 175488 6418489 175260 175261 175262 1752... | Siemens Healthcare Diagnostics Inc. | GKL | ||
| Z-0636-04 | Cytomics MXP Software, Version 1.0, Part No. 623688. | Siemens Healthcare Diagnostics Inc. | GKL | ||
| Z-0635-04 | CXP software, Part No. 623560, version 1.0 | Siemens Healthcare Diagnostics Inc. | GKL | ||
| Z-0712-04 | DCTM Digital Ceiling Tube Mount, model DCTM; a fully counter-balanced radiographic x-ray... | Del Medical, Inc. | IYB | ||
| Z-0719-04 | Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105... | Howmedica Osteonics Corp | LXH | ||
| Z-0734-04 | Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD PS port, Implantable Port... | Boston Scientific Corporation | LJT | ||
| Z-0733-04 | Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Low Profile PS port... | Boston Scientific Corporation | LJT | ||
| Z-0732-04 | Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD Titanium Port, Implantable... | Boston Scientific Corporation | LJT | ||
| Z-0731-04 | Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Mini Titanium port, Implantable... | Boston Scientific Corporation | LJT | ||
| Z-0710-04 | Biolox Ceramic Head XL | Plus Orthopedics | LZO | ||
| Z-0562-04 | BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only... | C.R. Bard Inc | KOD | ||
| Z-0539-04 | Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF | Staar Surgical AG | HQL | ||
| Z-0287-04 | Seneographe 600 Mammography X-Ray Systems (all versions) | GE Healthcare | IZH | ||
| Z-0286-04 | Seneographe 500 Mammography X-Ray Systems (all versions) | GE Healthcare | IZH | ||
| Z-0285-04 | Seneographe 800T Mammography X-Ray Systems | GE Healthcare | IZH | ||
| Z-0284-04 | Seneographe 700T Mammography X-Ray Systems | GE Healthcare | IZH | ||
| Z-0283-04 | Seneographe DMR Mammography X-Ray System (all versions) | GE Healthcare | IZH | ||
| Z-0582-04 | EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader... | Varian Medical Systems, Inc. | JAQ | ||
| Z-0633-04 | Bravo pH Monitoring System Receiver | Medtronic Gastroenterology / Urology | FGM | ||
| Z-0282-04 | Seneographe 2000D Digital Mammography X-Ray System | GE Healthcare | IZH | ||
| Z-0587-04 | BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile. | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0586-04 | BD First PICC Introsyte-N, 1.9Fr. x 50cm Single Lumen Procedure Kit. | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0581-04 | One Way Valve/Female to Male Flow, 22 mm I.D./22 mm O.D., Ref 396798, Lot ***, SINGLE USE... | Teleflex Medical | CBP | ||
| Z-0580-04 | One Way Valve/Male to Female Flow, 22 mm I.D./22 mm O.D., Ref 396799, Lot ***, SINGLE USE... | Teleflex Medical | CBP | ||
| Z-0579-04 | RFMD T-Piece With 2 one-way valves & tubing, Ref 395940, Lot***, SINGLE USE ONLY, Qty 1... | Teleflex Medical | CBP | ||
| Z-0578-04 | 4-Way Tee with 2 one-way valves, Ref 395945 Lot***, SINGLE USE ONLY, Qty 1 ea, RUSCH 2450... | Teleflex Medical | CBP | ||
| Z-0545-04 | Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later version... | GE Healthcare | BSZ | ||
| Z-0744-04 | Acuson Cypress Echocardiography System | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-0537-04 | Pump Tube, REF 8170,121; Suction Pump Drain Tube; An accessory to the suction pump... | Richard Wolf Medical Instruments Corp. | JOL | ||
| Z-0709-04 | Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact... | Action Products, Inc. | KNO | ||
| Z-0814-04 | CryoValve, Pulmonary Valve and Conduit | Artivion, Inc. | MIE | ||
| Z-0596-04 | MediSense Precision QID Blood Glucose Test Strips. The product is sold in box of 50 and... | AmeriSource Bergen | CGA | ||
| Z-0955-04 | Product is a device used in adenoid surgery and is labeled as Lusk Disposable Adenoid... | Medtronic Xomed, Inc. | KBJ | ||
| Z-0954-04 | The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub... | Medtronic Xomed, Inc. | FED | ||
| Z-0953-04 | Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur... | Medtronic Xomed, Inc. | GFF | ||
| Z-0764-04 | The BD Blood Glucose Monitoring Systems identified as the BD Latitude, and BD Logic... | Becton Dickinson & Co | NBW | ||
| Z-0763-04 | BD Test Strips. The US market BD Test Strips are identified by Catalog Numbers 322027... | Becton Dickinson & Co | NBW | ||
| Z-0632-04 | ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery... | Medtronic, Inc. | FGE | ||
| Z-0631-04 | ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery... | Medtronic, Inc. | FGE | ||
| Z-0630-04 | ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery... | Medtronic, Inc. | FGE | ||
| Z-0629-04 | ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery... | Medtronic, Inc. | FGE | ||
| Z-0628-04 | ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery... | Medtronic, Inc. | FGE | ||
| Z-0627-04 | ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery... | Medtronic, Inc. | FGE | ||
| Z-0626-04 | ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery... | Medtronic, Inc. | FGE | ||
| Z-0625-04 | ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery... | Medtronic, Inc. | FGE | ||
| Z-0624-04 | ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery... | Medtronic, Inc. | FGE | ||
| Z-0623-04 | ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery... | Medtronic, Inc. | FGE |