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-0088-2010 | Medtronic Enterra Therapy, Gastric Electrical Stimulation System, consisting of model... | Medtronic Neuromodulation | LNQ | ||
| Z-2067-2009 | Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 3.5 mm Product Code... | Abbott Medical | BTR | ||
| Z-2066-2009 | Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 3.0 mm Product Code... | Abbott Medical | BTR | ||
| Z-2065-2009 | Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 2.5 mm Product Code... | Abbott Medical | BTR | ||
| Z-2064-2009 | Portex Tracheal Tube, Cut to Length, Oral, Siliconized, 3.5 mm Product Code... | Abbott Medical | BTR | ||
| Z-2063-2009 | Portex Tracheal Tube, Cut to Length, Oral, Siliconized, 3.0 mm Product Code... | Abbott Medical | BTR | ||
| Z-2062-2009 | Portex Tracheal Tube, Cut to Length, Oral, Siliconized, 2.5 mm Product Code... | Abbott Medical | BTR | ||
| Z-2061-2009 | Portex Tracheal Tube, Oral/Nasal, Siliconized, 3.5 mm Product Code... | Abbott Medical | BTR | ||
| Z-2060-2009 | Portex Tracheal Tube, Oral/Nasal, Siliconized, 3.0 mm Product Code... | Abbott Medical | BTR | ||
| Z-2059-2009 | Portex Tracheal Tube, Oral/Nasal, Siliconized, 2.5 mm Product Code... | Abbott Medical | BTR | ||
| Z-2058-2009 | Portex Uncuffed Paediatric Sized Tracheal Tube Oral Nasal, Ivory 3.5 mm, Product Code... | Abbott Medical | BTR | ||
| Z-2057-2009 | Portex Uncuffed Paediatric Sized Tracheal Tube Oral Nasal, Ivory 3.0 mm, Product Code... | Abbott Medical | BTR | ||
| Z-2056-2009 | Portex Uncuffed Paediatric Sized Tracheal Tube, Oral Nasal , Ivory 2.5 mm, Product... | Abbott Medical | BTR | ||
| Z-1150-2010 | Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of... | Sybron Dental Specialties, Inc. | KLE | ||
| Z-0358-2011 | Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model... | Boston Scientific Corporation | KRA | ||
| Z-0357-2011 | Boston Scientific brand Neuro Renegade Hi-Flo Microcatheter, 150cm/20cm; Rx Only; Model... | Boston Scientific Corporation | KRA | ||
| Z-1970-2011 | LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0073-2010 | Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in... | Acumed LLC | HWC | ||
| Z-2248-2009 | AccuSure, U-100, 31Gauge, 1cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC... | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals | FMF | ||
| Z-2247-2009 | AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC... | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals | FMF | ||
| Z-0003-2010 | HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for... | Philips North America LLC | MKJ | ||
| Z-0830-2011 | Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560... | Stryker Corp. | FAT | ||
| Z-0618-2011 | Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060... | Stryker Corp. | HWC | ||
| Z-0554-2010 | Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1... | Zimmer GmbH | NKB | ||
| Z-0637-2010 | Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw. Sterile EO. The... | Gyrus ACMI, Inc. | GEI | ||
| Z-0636-2010 | Gyrus ACMI PKS Seal Open Forceps, model 915005PK, 9-3/4" Straight Jaw. Sterile EO. The... | Gyrus ACMI, Inc. | GEI | ||
| Z-0635-2010 | Gyrus ACMI PKS Seal Open Forceps, model 915000PK, 9-3/4" Curved Jaw. Sterile EO. The... | Gyrus ACMI, Inc. | GEI | ||
| Z-0634-2010 | Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" angled. Sterile EO. The device... | Gyrus ACMI, Inc. | GEI | ||
| Z-0633-2010 | Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" straight. Sterile EO. The device... | Gyrus ACMI, Inc. | GEI | ||
| Z-0632-2010 | Gyrus ACMI PKS Seal Open Forceps, model 3103PK, 9-3/4" curved. Sterile EO. The device... | Gyrus ACMI, Inc. | GEI | ||
| Z-2230-2009 | Maxi Move Scoop Stretcher; Note: The stretcher is an accessory to the Maxi Move Patient... | Arjohuntleigh AB | FSA | ||
| Z-0814-2010 | Abbott i-STAT ACT Kaolin Cartridges. In vitro diagnostic test which uses fresh whole... | Abbott Medical | JBP | ||
| Z-0813-2010 | Abbott i-STAT ACT Celite Cartridges. In vitro diagnostic test used to monitor moderate... | Abbott Medical | JBP | ||
| Z-1069-2010 | CLAY ADAMS Dynac III Centrifuge, 120V, Model Number 420104 DYNAC III is a... | Becton Dickinson & Co | JQC | ||
| Z-2109-2009 | Boston Scientific, Contour SE Microspheres, for tumor treatment. UPN... | Boston Scientific Corporation | NAJ | ||
| Z-2229-2009 | St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM, Lot 4219... | Abbott Medical | DQX | ||
| Z-2228-2009 | St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372... | Abbott Medical | DQX | ||
| Z-0159-2010 | Bausch & Lomb ReNu Multi-Purpose Solution, 12 fl.oz. (355 ml), Bausch & Lomb... | Bausch & Lomb Incorporated | LPN | ||
| Z-2047-2009 | Pedi-Cap CO2 Detector, 1 kg - 15 kg, Tyco Healthcare Group LP, Nellcor Puritan Bennett... | Medtronic, Inc. | CCK | ||
| Z-2316-2009 | Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software; GE Healthcare... | GE Healthcare | LMB | ||
| Z-0083-2010 | Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills, burrs... | The Anspach Effort, Inc. | HBE | ||
| Z-0528-2010 | GE Healthcare Definium 8000.Model # 5131070. GE Healthcare, 3000 North Grandview... | GE Healthcare | KPR | ||
| Z-0527-2010 | GE Healthcare Revolution XR/d. Model #'s 2259988-2 & 2351505. GE Healthcare, 3000 North... | GE Healthcare | KPR | ||
| Z-0526-2010 | GE Healthcare Proteus XR/a. Model # 2259988. GE Healthcare, 3000 North Grandview... | GE Healthcare | KPR | ||
| Z-3277-2011 | CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software... | Picis Clinical Solutions, Inc. | NSX | ||
| Z-0005-2010 | GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human... | GE Healthcare | JAA | ||
| Z-0004-2010 | GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy. | GE Healthcare | JAA | ||
| Z-2110-2009 | Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated... | Physio Control, Inc. | DXN | ||
| Z-0819-2010 | CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC, a... | Veridex, LLC | NQI | ||
| Z-2251-2009 | BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610... | Brainlab, Inc. | MUJ |