Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
-
Class II · 1+ years ago
Maquet Cardiovascular, LLC Heartstring III Proximal Seal System. Intravascular recall: Three failure modes have been identified: failure of the Heartstring Seal
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and…
-
Class II · 1+ years ago
Folsom Metal Products, Inc. Frontier Devices, REF: 301.912S1 recall: Labeling includes shelf life that has not been validated
Labeling includes shelf life that has not been validated.
-
Class I · 1+ years ago
3M Company 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370 recall: Field action to clarify the flow rates and inlet fluid temperatures
Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming…
-
Class II · 1+ years ago
Abbott Point Of Care Inc. i-STAT EG6+ cartridge. List Number: 03P77-25 recall: Lack of a 510(k) premarket clearance for the i-STAT CG8+
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium…
-
Class II · 1+ years ago
Agilent Technologies Denmark ApS Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy recall: Their is the potential for weak staining which may result in false negative
Their is the potential for weak staining which may result in false negative CD20 identification.
-
Elevated risk · 1+ years ago
Olympus ViziShot 2 Flex Ebus -Tbna needles recall: Device & Drug Safety - Defect
Device & Drug Safety - Defect
-
Class II · 1+ years ago
Boston Scientific Encore Advantage Kit, Material Numbers : 1 recall: The Encore 26 Inflation Device is used with balloon dilation catheters
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An…
-
Class II · 1+ years ago
Siemens Healthcare Diagnostics, Inc. Atellica CH Urinary/Cerebrospinal Fluid Protein recall: Potential for falsely depressed patient, quality control (QC)
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
-
Class II · 1+ years ago
B.Braun Medical S.A.S. Brand Name: Celsite Product Name: Celsite Babyport SET PUR 4 recall: The potential for minor injury such as damage to the vessel and/or tearing
The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
-
Class II · 1+ years ago
Contract Medical International GmbH Brand Name: Fortress Introducer Sheath System recall: Units may have been packaged with an incorrect pouch label
Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the…
-
Class II · 1+ years ago
NOxBOXi Nitric Oxide Delivery System recall: Replacement of the internal Sample Pump due to high failure rates
Replacement of the internal Sample Pump due to high failure rates.
-
Class II · 1+ years ago
Omnia Medical TiBrid Stand Alone Intervertebral Body Fusion Device recall: Failure of fusion system instruments in the field
Failure of fusion system instruments in the field.
-
Class II · 1+ years ago
AVID Medical, Inc. Halyard, CPT Basic IR Pack recall: Potential for open header bag seals, compromising sterility
Potential for open header bag seals, compromising sterility.
-
Class II · 1+ years ago
Waldemar Link GmbH & Co. KG LinkSymphoKnee System, Tibial Component recall: Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
-
Class II · 1+ years ago
Boston Scientific Encore 26 Inflation Device recall: The Encore 26 Inflation Device is used with balloon dilation catheters
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An…
-
Class II · 1+ years ago
Encore Medical, LP Brand Name: DJO Surgical Product Name: Altivate Reverse Wedge recall: Their is a potential that the reamer may kick or bind up during
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
-
Class II · 1+ years ago
Merit Medical Systems, Inc. 10Fore Hemostasis Valve recall: Due to a manufacturing issue involving the silicone quad ring where the ring
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the…
-
Class II · 1+ years ago
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical recall: Retroactive; Due to complaints, labeling correction for permanent
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would…
-
Class II · 1+ years ago
Encore Medical, LP Brand Name: DJO Surgical Product Name: Altivate Reverse Wedge recall: Their is a potential that the reamer may kick or bind up during
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
-
Class II · 1+ years ago
Omnia Medical TiBrid Stand Alone Intervertebral Body Fusion Device recall: Failure of fusion system instruments in the field
Failure of fusion system instruments in the field.
-
Class II · 1+ years ago
Boston Scientific UroMax Ultra Kit, Material Numbers : 1. M0062251200 recall: The Encore 26 Inflation Device is used with balloon dilation catheters
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An…
-
Class II · 1+ years ago
Boston Scientific Corporation Preventive Maintenance Kit Icefx recall: Certain desiccant tube subassemblies were built with end caps
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
-
Class II · 1+ years ago
Encore Medical, LP Brand Name: DJO Surgical Product Name: FA S Altivate Reverse recall: Their is a potential that the reamer may kick or bind up during
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
-
Class II · 1+ years ago
Seaspine Orthopedics Corporation Reef TA Inserter recall: Inserter, used as part of a system with an intervertebral body fusion device
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper…