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-1108-2007 | Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec... | Abbott Medical | DSQ | ||
| Z-1021-2007 | Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton... | Bausch & Lomb Incorporated | HNO | ||
| Z-0998-2007 | Eyemaxx MVR 20g Microsurgical Knife, Item #MX3020 | Oasis Medical, Inc. | HNN | ||
| Z-0997-2007 | Premier Edge MVR 20g Microsurgical Knife, Angled, Item PE-3520-A | Oasis Medical, Inc. | HNN | ||
| Z-0996-2007 | Premier Edge MVR 20g Microsurgical Knife, Item PE-3520 | Oasis Medical, Inc. | HNN | ||
| Z-0995-2007 | Premier Edge MVR 19g Microsurgical Knife, Item PE-3519 | Oasis Medical, Inc. | HNN | ||
| Z-0580-2008 | ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309... | Siemens Healthcare Diagnostics Inc. | MMI | ||
| Z-1019-2007 | Various Sizes of Sterile Polyglycolic Acid Synthetic Surgical Suture-NDR, POLYGLY 2-0... | Teleflex Medical | GAM | ||
| Z-1018-2007 | Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK BL MF 0 TC-43 2N 48, Catalog... | Teleflex Medical | GAM | ||
| Z-1017-2007 | Various Types and Sizes of Polyethylene Synthetic Nonabsorable Sutures-Polyester, TEV GN... | Teleflex Medical | GAM | ||
| Z-1016-2007 | Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical... | Teleflex Medical | GAM | ||
| Z-1015-2007 | Various Types, Sterile/Nonsterile Stainless Steel Nonabsorable Surgical Sutures-SS Wire... | Teleflex Medical | GAM | ||
| Z-1014-2007 | Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Sutures -Bondek, BON+ BG BR... | Teleflex Medical | GAM | ||
| Z-1013-2007 | Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture--Bondek, BON+ VI BR... | Teleflex Medical | GAM | ||
| Z-1012-2007 | Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0... | Teleflex Medical | GAM | ||
| Z-1011-2007 | Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture- Bondek, TOPS ASSY... | Teleflex Medical | GAM | ||
| Z-1001-2007 | Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product... | Medrad, Inc. | LFR | ||
| Z-1046-2007 | Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or... | CooperSurgical, Inc. | GEH | ||
| Z-1045-2007 | Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X... | CooperSurgical, Inc. | GEH | ||
| Z-1078-2007 | Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx... | CareFusion 303, Inc | FRN | ||
| Z-1010-2007 | BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions... | Brainlab, Inc. | IWY | ||
| Z-1089-2007 | BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200) | Abbott Medical | MWI | ||
| Z-1116-2007 | Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is... | B Braun Medical Inc | DYG | ||
| Z-1201-2007 | ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863 | Sendx Medical, Inc. | CHL | ||
| Z-1144-2007 | Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm... | Kimberly-Clark Corporation | BTR | ||
| Z-1143-2007 | Kimberly-Clark Microcuff Endotracheal Tube, Pediatric Oral/Nasal Magill, sizes 3.0mm... | Kimberly-Clark Corporation | BTR | ||
| Z-1090-2007 | Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer... | Medtronic Perfusion Systems | DTQ | ||
| Z-1160-2007 | Boston Scientific Impulse Flextrusion Shaft 5F FL4 16391-22 H74916391222, (5-Pack Carton... | Boston Scientific Corporation | DQO | ||
| Z-1159-2007 | Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391022, (5-Pack Carton... | Boston Scientific Corporation | DQO | ||
| Z-0516-2009 | Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic... | Quantimetrix Corp. | JPK | ||
| Z-0515-2009 | Quantimetrix SpinalScopics Spinal Fluid Cell Count Control. Spinalscopics is a plastic... | Quantimetrix Corp. | JJY | ||
| Z-0514-2009 | Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control. The intended... | Quantimetrix Corp. | JJW | ||
| Z-0513-2009 | Quantimetrix QuanTscopics Urine Microscopics Control. QuanTscopics is a plastic bottle... | Quantimetrix Corp. | JJY | ||
| Z-1233-2007 | MULTIGENT Acetaminophen, List Number 2K99-20 | Abbott Medical | LDP | ||
| Z-1232-2007 | Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30 | Abbott Medical | CHI | ||
| Z-1172-2007 | Non-AC-powererd Patient Lifts for assisting patients when bathing and toileting-sold... | The Sisus Corporation | FSA | ||
| Z-1075-2007 | AirLife nCPAP System Driver; a nasal continuous positive airway pressure device, which is... | Medtronic, Inc. | BZD | ||
| Z-1188-2007 | XSYSTEMS Quinidine Controls are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM... | Abbott Diagnostic International, Ltd. | LGI | ||
| Z-1187-2007 | XSYSTEMS Quinidine Calibrators consists of six bottles of Cal A-F (2.5 mL each).-Product... | Abbott Diagnostic International, Ltd. | LGI | ||
| Z-1186-2007 | AxSYM Quinidine Controls - are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM... | Abbott Diagnostic International, Ltd. | LGI | ||
| Z-1185-2007 | AxSYM Quinidine Standard Calibrators - consist of six bottles of Cal A (6ml) and Cals B-F... | Abbott Diagnostic International, Ltd. | LGI | ||
| Z-1231-2010 | Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc... | Elekta Limited | IWB | ||
| Z-0365-2008 | Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number... | Visx Incorporated, a Subsidiary of AMO Inc | LZS | ||
| Z-1685-2009 | Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated... | Howmedica Osteonics Corp | MEH | ||
| Z-0071-2008 | NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator | Neomedix Corp. | BTA | ||
| Z-0111-2008 | Brilliance CT Systems 64 slice configuration. Computed tomography scanner. | Philips North America LLC | JAK | ||
| Z-0110-2008 | Brilliance CT Systems, 40 slice configuration. Computed tomography scanner. | Philips North America LLC | JAK | ||
| Z-1093-2007 | COMPLETE Amino Moist Multi-Purpose Solution (JAPAN only brand), Formula 9451X, Product... | Advanced Medical Optics, Inc. | LPN | ||
| Z-1092-2007 | COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION, Formula 9451X; (A) Fourteen US Product... | Advanced Medical Optics, Inc. | LPN | ||
| Z-0928-2007 | OEC Miniview 6800 mobile fluoroscopic x-ray system, GE Healthcare, Surgery, Salt Lake... | GE Healthcare | JAA |