Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
-
Class II · 26 days ago
Midmark IQvitals Zone, automatically and noninvasively measures recall: A performance issue may result in inaccurate blood pressure readings
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
-
Class II · 26 days ago
Medline convenience kits containing Healthmark Instrument Channel recall: Kits contain Healthmark Instrument Channel Brushes
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of…
-
Class II · 26 days ago
Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/ recall: Potential for detachment of ceramic tip due to manufacturing without
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
-
Class II · last month
Medline Industries, LP Convenience kits Cataract Pack Dynj59881A recall: Kits may exhibit open seals in sterile pouch packaging. Open seal
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to…
-
Class I · last month
Bard Access Systems, Inc. DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150 recall: this is a downstream recall of class I recall RES 98777
this is a downstream recall of class I recall RES 98777
-
Class II · last month
Maquet Cardiopulmonary Gmbh Percutaneous Insertion Kit , dilator set L recall: The packaging may not consistently maintain sterile barrier integrity
The packaging may not consistently maintain sterile barrier integrity.
-
Class II · last month
Medical Action Industries, Inc. 306 Blood Culture Collection Venipuncture Kit 20/Cs recall: Blood culture convenience kits contain a component subject to a drug recall
Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the…
-
Class II · last month
Nuclein LLC Brand Name: Dash Rapid PCR Instrument Product Name: Dash Rapid PCR recall: Due to a software issue
Due to a software issue
-
Class II · last month
Stryker Sustainability Solutions REF:2B5LT Ethicon Endo-Surgery recall: Reusable access port system may crack or seperate during use
Reusable access port system may crack or seperate during use.
-
Class II · last month
ICU Medical, Inc. CADD Yellow Medication Cassette Reservoir with NRFit connector US recall: Reservoirs may exhibit medication leakage at the joint between luer connector
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy…
-
Class II · last month
embecta Medical II LLC EWO_02513 For Investigational Use Only Nano Un-Cannulated Demo recall: Retrospectively reported: Pen needles labeled 'For Investigational Use Only'
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
-
Class II · last month
Howmedica Osteonics Corp. Axle PIN Assy Large Elbow Cobalt Chrome recall: Affected devices were manufactured with Ultra High Molecular Weight
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the…
-
Class II · last month
Datex-Ohmeda, Inc. Aisys, Datex-Ohmeda anesthesia system recall: Anesthesia Delivery Systems containing certain electronic gas mixer
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2…
-
Class II · last month
restor3d Inc. Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut , REF: 5831-9006 recall: Ankle implantation systems were packaged with incorrect patient-specific
Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use…
-
Class I · last month
AVID Medical, Inc. Haylard Continuous Nerve Block Tray recall: Potential for product quality and sterility issues regarding kits containing
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
-
Class I · last month
Medline Convenience Kits: 1) Port Access KIT Univ OF ALA recall: The kits contain certain lots of sterile applicators which may contain fungal
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions…
-
Class II · last month
Howmedica Osteonics Corp. Triathlon Hinge Insert Size 4 11MM 5612-P-411 Triathlon recall: Affected devices were manufactured with Ultra High Molecular Weight
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the…
-
Class II · last month
Medline Industries, LP Convenience kits Minor Pack Dynj58421A Springhill Minor Pack recall: Kits may exhibit open seals in sterile pouch packaging. Open seal
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to…
-
Class I · last month
Nova Biomedical Corporation StatStrip Glucose Hospital Meter System recall: A software synchronization/timing issue in the barcode scanning and patient
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain…
-
Class II · last month
GE Healthcare Enterprise Archive V8, software product for receiving, archiving recall: Under certain conditions historical imaging data migrated from a legacy
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this…
-
Class II · last month
Philips Patient Information Center iX REF:866389 recall: Due to software malfunction, patient information system may freeze and become
Due to software malfunction, patient information system may freeze and become unresponsive.
-
Class II · last month
Stryker Sustainability Solutions REF:B11LT Ethicon Endo-Surgery recall: Reusable access port system may crack or seperate during use
Reusable access port system may crack or seperate during use.
-
Class II · last month
GE Healthcare Workflow Core Services V8, intended to provide set of services recall: Under certain conditions historical imaging data migrated from a legacy
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this…
-
Class II · last month
Howmedica Osteonics Corp. Scorpio Recessed Metal Backed Patella 3045-0026 3045-0028 recall: Affected devices were manufactured with Ultra High Molecular Weight
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the…