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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 381–400 of 400 recalls

Class IICompleted

Breast Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

April 20, 2015 · DeviceView details →

Class IICompleted

Basic Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

April 20, 2015 · DeviceView details →

Class IICompleted

Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

April 20, 2015 · DeviceView details →

Class IICompleted

ACL Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

April 20, 2015 · DeviceView details →

Class IICompleted

Face Lift Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

April 20, 2015 · DeviceView details →

Class IICompleted

Stradi 4500 - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

April 20, 2015 · DeviceView details →

Class IICompleted

Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

April 20, 2015 · DeviceView details →

Class IICompleted

Gyn Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

April 20, 2015 · DeviceView details →

Class IICompleted

Set Up Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

April 20, 2015 · DeviceView details →

Class IICompleted

Bariatric Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

April 20, 2015 · DeviceView details →

Class IICompleted

Neurosurgery Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

April 20, 2015 · DeviceView details →

Class IICompleted

Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

April 20, 2015 · DeviceView details →

Class IICompleted

Eye Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

April 20, 2015 · DeviceView details →

Class IICompleted

Abdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare, LLC.

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

April 20, 2015 · DeviceView details →

Class IICompleted

MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.

Baxter Healthcare Corp.

Product may have separating or protruding sponges

January 22, 2015 · DeviceView details →

Class IICompleted

Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.

Smiths Medical ASD, Inc.

Needle is not captured in the needle safety sheath in specific lots.

November 21, 2014 · DeviceView details →

Class IICompleted

Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.

Smiths Medical ASD, Inc.

Needle is not captured in the needle safety sheath in specific lots.

November 21, 2014 · DeviceView details →

Class IICompleted

Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.

Smiths Medical ASD, Inc.

Needle is not captured in the needle safety sheath in specific lots.

November 21, 2014 · DeviceView details →

Class IICompleted

Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100 filters/box, for single patient use, latex free, box of 100 Reorder Numbers: 5553100 (single filter reorder no. 5553000), 5554100 (single filter reorder no. 5554000), 5555100 (single filter reorder no. 5555000), 5559100 (single filter reorder no. 5559000), 7773100 (single filter reorder no. 7773000), and 7774100 (single filter reorder no. 7774000). The firm name on the label is Alliance Tech Medical, Inc., Granbury, TX, manufactured in Taiwan.

Alliance Tech Medical, Inc

Patients have experienced a bad taste associated with the filters.

October 6, 2014 · DeviceView details →

Class IICompleted

Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Teleflex Medical

The knife handles slot depth is out of specification, so blades may not fit on the handles properly.

September 26, 2014 · DeviceView details →

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