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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844.

Mar 3, 2017 Surgical Instruments View Details →

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

Mar 15, 2017 Surgical Instruments Nationwide View Details →

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

Mar 15, 2017 Surgical Instruments Nationwide View Details →

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

Mar 15, 2017 Surgical Instruments Nationwide View Details →

Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process.

Mar 7, 2017 Diagnostic Equipment View Details →

The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.

Feb 24, 2017 Diagnostic Equipment Nationwide View Details →

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

Mar 15, 2017 Surgical Instruments Nationwide View Details →

BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection.

Mar 16, 2017 Infusion Pumps Nationwide View Details →

Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.

Feb 13, 2017 Diagnostic Equipment View Details →

Product sterility is compromised due to breach of sterile barrier

Mar 3, 2017 Other Medical Devices Nationwide View Details →

Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process.

Mar 7, 2017 Diagnostic Equipment View Details →

The product was marketed without 510(k) clearance.

Jun 17, 2015 Other Medical Devices View Details →

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

Mar 15, 2017 Surgical Instruments Nationwide View Details →

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

Mar 15, 2017 Surgical Instruments Nationwide View Details →

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

Mar 15, 2017 Surgical Instruments Nationwide View Details →

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

Mar 15, 2017 Surgical Instruments Nationwide View Details →