Delaware Recalls

2,567 recalls on record affecting Delaware

medical Class II
2017-01-18

GE OEC Medical Systems, Inc recalls The OEC 9900 Elite mobile fluoroscopy system is designed to

GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.

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medical Class II
2017-01-18

Stryker Sustainability Solutions recalls Reprocessed Electrophysiology Catheter Cables Catalog Numbe

A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.

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medical Class II
2017-01-18

Stryker Sustainability Solutions recalls Reprocessed Ablation Catheter Cable Catalog Number: CR3425C

A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.

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medical Class II
2017-01-18

GE OEC Medical Systems, Inc recalls OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 680

GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.

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medical Class II
2017-01-18

GE OEC Medical Systems, Inc recalls OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is des

GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.

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medical Class II
2017-02-01

Sekisui Diagnostics P.E.I. Inc. recalls Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-

Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.

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medical Class II
2017-02-01

On-X Life Technologies, Inc. recalls Chord-X Chordal Sizer is designed to assist in determining t

Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Left Housing, Right Housing and Barrel components, 2) Loose plastic particulate was found within sealed primary packages, 3) Loose hair was discovered within four sealed primary packages and 4) Assembly error, wherein Left and Right Housing components were acceptably press-fit together, was discovered within one sealed primary package. One of the Left Housing press-fit pins was not pressed into the associated hole of the Right Housing, resulting in a small gap in the housing assembly.

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medical Class II
2017-02-22

Philips Medical Systems (Cleveland) Inc recalls BrightView XCT

The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.

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medical Class II
2017-02-22

Philips Medical Systems (Cleveland) Inc recalls BrightView X upgraded to XCT 882454

The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.

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medical Class II
2017-03-01

Tosoh Bioscience, Inc. recalls Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.

The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of HbA1c, e.g. 9%, but not at the diagnostic medical decision point of 6.5%.

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medical Class II
2017-03-01

BioMerieux SA recalls ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-4

Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.

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medical Class II
2017-03-08

Cook Inc. recalls Flexor Radial Access Set, Individual product is packaged in

Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.

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medical Class II
2017-03-08

Cook Inc. recalls Check-Flo Introducer Hausdorf-Lock Atrial, Individual produc

Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.

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medical Class II
2017-03-08

Cook Inc. recalls Check-Flo Performer Introducer Set, Individual product is pa

Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.

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medical Class II
2017-03-08

Cook Inc. recalls Check-Flo Performer Introducer, Individual product is packag

Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.

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medical Class II
2017-03-08

Cook Inc. recalls Check-Flo Hemostasis Assembly, Individual product is package

Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.

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medical Class II
2017-03-08

Cook Inc. recalls TriForce Peripheral Crossing Set, Individual product is pack

Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.

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medical Class II
2017-03-08

Cook Inc. recalls Micropuncture Check-Flo Performer Introducer Set, Individual

Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.

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medical Class II
2017-03-22

Medtronic recalls BNX Fine Need Aspiration System (22GA); Material/Part#: DSN

Handle may break during use.

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medical Class II
2017-03-22

Medtronic recalls SharkCore LG Fine Needle Biopsy System (19GA); Material/Part

Handle may break during use.

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Showing 20 of 2,567 recalls. Use search to filter further.