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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 1518 of 1581

Evidence Product Join Root cause
device-recall:cfres:156572 PALLAS M/MAXIMIS 45mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine. Official recall number · Z-2949-2017 Device Design
device-recall:cfres:156380 PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine. Official recall number · Z-2895-2017 Device Design
device-recall:cfres:157712 PALLAS M/MAXIMIS Inside Bender (L) and (R). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine. Official recall number · Z-2974-2017 Device Design
device-recall:cfres:156568 PALLAS M/MAXIMIS 70mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine. Official recall number · Z-2945-2017 Device Design
device-recall:cfres:157760 PALLAS M/MAXIMIS I Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine. Official recall number · Z-3004-2017 Device Design
device-recall:cfres:157734 PALLAS M/MAXIMIS Extension Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine. Official recall number · Z-2988-2017 Device Design
device-recall:cfres:156573 PALLAS M/MAXIMIS 50mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine. Official recall number · Z-2950-2017 Device Design
device-recall:cfres:156181 Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs. Official recall number · Z-2695-2017 Device Design
device-recall:cfres:156177 Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs. Official recall number · Z-2691-2017 Device Design
device-recall:cfres:157190 Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body. Official recall number · Z-2804-2017 Under Investigation by firm
device-recall:cfres:157251 Piston Syringe, 60 CC L/S, 50 per box, 8 boxes/case, 400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body. Official recall number · Z-2862-2017 Under Investigation by firm
device-recall:cfres:157243 Piston Syringe, 5 CC L/S, 100 per box, 20 boxes/case, 2,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body. Official recall number · Z-2854-2017 Under Investigation by firm
device-recall:cfres:157835 Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence Official recall number · Z-2760-2017 Radiation Control for Health and Safety Act
device-recall:cfres:157452 SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, Official recall number · Z-2865-2017 Use error
device-recall:cfres:157247 Piston Syringe, 20 CC L/S, 100 per box, 9 boxes/case, 900/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body. Official recall number · Z-2858-2017 Under Investigation by firm
device-recall:cfres:157032 InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites. Official recall number · Z-2803-2017 Process design
device-recall:cfres:157235 Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body. Official recall number · Z-2847-2017 Under Investigation by firm
device-recall:cfres:156508 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein). Official recall number · Z-2716-2017 Nonconforming Material/Component
device-recall:cfres:156955 IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats Official recall number · Z-2652-2017 Software design
device-recall:cfres:156760 Arrow Glide Thru Peel-Away Sheath/Dilator Introducer Official recall number · Z-2699-2017 Device Design
device-recall:cfres:156069 Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum. Official recall number · Z-2650-2017 Labeling Change Control
device-recall:cfres:154740 SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Official recall number · Z-2640-2017 Component change control
device-recall:cfres:156514 PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).. Official recall number · Z-2720-2017 Nonconforming Material/Component
device-recall:cfres:155645 High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications. Official recall number · Z-2629-2017 Under Investigation by firm
device-recall:cfres:155545 Access Thyroglobulin, A34085G, Catalog No. 33860 Official recall number · Z-2636-2017 Device Design

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