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-0678-2007 | OEC 8800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. | GE Healthcare | JAA | ||
| Z-0677-2007 | OEC 9800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. | GE Healthcare | JAA | ||
| Z-0676-2007 | OEC 9900 Elite image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake... | GE Healthcare | JAA | ||
| Z-0243-2008 | OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union... | Mizuho Orthopedic Systems Inc | LHN | ||
| Z-0242-2008 | OSI ProFx Operating Room Table 6850 , Pelvic Reconstruction Orthopedic Surgery Table... | Mizuho Orthopedic Systems Inc | JEA | ||
| Z-0241-2008 | OSI, Allegro 6800 Imaging Table (Operating), single pedestal AC or battery operated... | Mizuho Orthopedic Systems Inc | LHN | ||
| Z-0779-2007 | American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic | Sekisui Diagnostics, LLC | GIR | ||
| Z-0737-2007 | CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional... | Roche Diagnostics GmbH | GJS | ||
| Z-0665-2007 | Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm... | Cook Incorporated | DQY | ||
| Z-0641-2007 | Philips HeartStart FR2+ Defibrillator Automated External Defibrillator (AED) Catalog... | Philips North America LLC | MKJ | ||
| Z-0285-2008 | Si emans Evansi, with patient table, Part No: 44 81 586, and without patient table Part... | Siemens Medical Solutions USA, Inc. | KPQ | ||
| Z-0284-2008 | Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with... | Siemens Medical Solutions USA, Inc. | KPQ | ||
| Z-0283-2008 | Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with CT... | Siemens Medical Solutions USA, Inc. | KPQ | ||
| Z-0282-2008 | Si emans Simiae NT Cassette Holder Electronic Imaging Device (Image Identifier) Part No... | Siemens Medical Solutions USA, Inc. | KPQ | ||
| Z-0281-2008 | Si emans Simiae 3000 Cassette Holder Electronic Imaging device (Image Identifier), with... | Siemens Medical Solutions USA, Inc. | KPQ | ||
| Z-0761-2007 | Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company... | Bio-Logic Systems Corp. | GWQ | ||
| Z-0967-2007 | Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes... | STERIS Corporation | MED | ||
| Z-0002-2008 | FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in... | Siemens Healthcare Diagnostics Inc. | LXG | ||
| Z-0727-2007 | Sunrise Medical-Hoyer Advance Patient Lifts (Portable and Folding Patient Lift) Sunrise... | Joerns Healthcare | FSA | ||
| Z-0854-2007 | LADAR6000 Excimer Laser System | Alcon Laboratories | LZS | ||
| Z-0621-2007 | Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The... | Remel Inc | JSI | ||
| Z-0703-2007 | AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical... | American Medical Systems, Inc. | FAE | ||
| Z-0702-2007 | AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical... | American Medical Systems, Inc. | FAE | ||
| Z-0701-2007 | SCANLAN International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use, catalog... | Scanlan International Inc | KDC | ||
| Z-0728-2007 | ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and... | Abbott Medical | CHP | ||
| Z-0669-2007 | BD Sensi-Disc Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10... | Becton Dickinson & Co | JTN | ||
| Z-0615-2007 | Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number... | Gyrus ACMI, Inc. | KNS | ||
| Z-0614-2007 | Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm-Reference Number: 006689-901 | Gyrus ACMI, Inc. | KNS | ||
| Z-0613-2007 | Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32 | Gyrus ACMI, Inc. | KNS | ||
| Z-0581-2007 | Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR AED' brand... | Defibtech LLC | MKJ | ||
| Z-0580-2007 | Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand... | Defibtech LLC | MKJ | ||
| Z-1189-2007 | BacT/ALERT FN Culture Bottles, Product Number 259793 | bioMerieux, Inc. | MBD | ||
| Z-1134-2007 | GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System, Software Version... | GE Medical Systems Information Technologies, Inc. | DQK | ||
| Z-1133-2007 | GE Medical Systems CardioLab System, electrophysiological data system, Software Version... | GE Medical Systems Information Technologies, Inc. | DQK | ||
| Z-1132-2007 | GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version... | GE Medical Systems Information Technologies, Inc. | DQK | ||
| Z-0620-2007 | Baxter Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing... | Baxter Healthcare Corporation | FPA | ||
| Z-0619-2007 | Baxter Interlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene... | Baxter Healthcare Corporation | FPA | ||
| Z-0618-2007 | Baxter Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene... | Baxter Healthcare Corporation | FPA | ||
| Z-1307-2008 | Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with... | AGFA Healthcare Corp. | LLZ | ||
| Z-0748-2007 | DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the... | Diasorin Inc. | JNO | ||
| Z-0719-2007 | BD 30ml Syringe Luer-Lok tip Sterile BD, Franklin Lakes, NJ Made in USA | Becton Dickinson & Co | FMF | ||
| Z-0629-2007 | EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain. | Merit Medical Systems, Inc. | KMK | ||
| Z-0628-2007 | StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit... | Merit Medical Systems, Inc. | KMK | ||
| Z-0627-2007 | StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit... | Merit Medical Systems, Inc. | KMK | ||
| Z-0594-2007 | Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in... | Abbott Diagnostics Scarborough, Inc. | GHH | ||
| Z-0710-2007 | Sea-Clens Wound Cleanser, 6 fl. oz., Manufactured by Coloplast Corp., Marietta, GA... | MEDLINE INDUSTRIES, LP - Northfield | KMF | ||
| Z-0780-2007 | Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s... | Mizuho Orthopedic Systems Inc | FWZ | ||
| Z-0616-2007 | The iSight PACS (picture archiving and communications system) a software package used... | Philips North America LLC | LLZ | ||
| Z-1101-2007 | Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers... | Sunnex, Inc. | FTA | ||
| Z-1100-2007 | Sunnex Celestial Star MR-16 (lamp holder) Medical Examination Lighting used in Model... | Sunnex, Inc. | FTA |