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Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 1553 of 1581

Evidence Product Join Root cause
device-recall:cfres:131357 Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names. Official recall number · Z-0557-2015 No Marketing Application
device-recall:cfres:131262 Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand Official recall number · Z-0509-2015 Software Design Change
device-recall:cfres:131363 Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Ambler Surgical brand name. Official recall number · Z-0559-2015 No Marketing Application
device-recall:cfres:131333 Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names Official recall number · Z-0552-2015 No Marketing Application
device-recall:cfres:131328 Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments brand names. Official recall number · Z-0550-2015 No Marketing Application
device-recall:cfres:131304 ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen. Official recall number · Z-0565-2015 Process control
device-recall:cfres:131288 A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names. Official recall number · Z-0535-2015 No Marketing Application
device-recall:cfres:131727 Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability. Official recall number · Z-0581-2015 Labeling mix-ups
device-recall:cfres:130631 Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy. Official recall number · Z-0147-2015 Error in labeling
device-recall:cfres:130754 Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory. Official recall number · Z-0216-2015 Device Design
device-recall:cfres:130415 Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece. Official recall number · Z-0172-2015 Process control
device-recall:cfres:130986 Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria. Official recall number · Z-0233-2015 Labeling Change Control
device-recall:cfres:130886 Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases. Official recall number · Z-0224-2015 Device Design
device-recall:cfres:130985 Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria. Official recall number · Z-0232-2015 Labeling Change Control
device-recall:cfres:130122 Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated Official recall number · Z-0090-2015 Device Design
device-recall:cfres:130123 Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated Official recall number · Z-0091-2015 Device Design
device-recall:cfres:130186 Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. Official recall number · Z-0137-2015 Device Design
device-recall:cfres:130724 Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4), Temperature, Functional arterial oxygen saturation (SpO2), End-tidal & inspired CO2, ECG monitoring with arrhythmia and ST-segment analysis, 12-Lead resting ECG, Cardiac output (C)). The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility. Official recall number · Z-0110-2015 Device Design
device-recall:cfres:130468 ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. Official recall number · Z-0055-2015 Material/Component Contamination
device-recall:cfres:130088 Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE Official recall number · Z-0023-2015 Process control
device-recall:cfres:130170 Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. Official recall number · Z-0015-2015 Mixed-up of materials/components
device-recall:cfres:130172 Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. Official recall number · Z-0017-2015 Mixed-up of materials/components
device-recall:cfres:130450 ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. Official recall number · Z-0052-2015 Material/Component Contamination
device-recall:cfres:130173 Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. Official recall number · Z-0018-2015 Mixed-up of materials/components
device-recall:cfres:131710 TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3) Official recall number · Z-0507-2015 Software design

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