Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · last month
ICU Medical, Inc. Plum administration sets recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
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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…
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Class I · last month
Nova Biomedical Corporation StatStrip Glucose and B- Ketone meter 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…
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Class I · last month
AVID Medical, Inc. Haylard Univ Imaging Biopsy Trucustom 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.
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Class I · last month
Abiomed, Inc. Automated Impella Controller with the below product descriptions recall: The potential for purge cassette recognition issues due to the failure
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
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Class II · last month
GE Healthcare Centricity PACS Server V7, intended for managing digital medical images 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…
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Class II · last month
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/ recall: Extra small (ES) and Extra-large (XL) infant sleep sacks have
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
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Class II · last month
ICU Medical, Inc. IV Sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
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Class II · last month
Medline Convenience Kit: Open Heart A Pack, Product Number Dynj43008N recall: The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product…
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Class II · last month
ICU Medical, Inc. Oncology sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
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Class II · last month
Datex-Ohmeda, Inc. Aisys CS2, 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…
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Class II · last month
ICU Medical, Inc. Oncology sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
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Class I · last month
Nova Biomedical Corporation StatStrip Glucose and B- Ketone meter 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…
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Class II · last month
GE Medical Systems Information Technologies Inc Carescape Central Station CSCS V3 recall: Device may not resume patient monitoring for at least 3 minutes following
Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of…
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Class I · last month
Medline Convenience Kits: 1) DYKM1000B 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…
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Class I · last month
AVID Medical, Inc. Haylard 18G Single Shot EPI 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.
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Class II · last month
Datex-Ohmeda, Inc. Et Control, Software option for anesthesia gas machine to achieve 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…
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Class II · last month
Datex-Ohmeda, Inc. Aisys CS2 with Et Control, 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…
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Class II · last month
Stryker Sustainability Solutions REF:2B5ST Ethicon Endo-Surgery recall: Reusable access port system may crack or seperate during use
Reusable access port system may crack or seperate during use.
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Class II · last month
Atrium Medical Corporation Getinge PVC Thoracic Catheter, Soft PVC Right Angle recall: An Out of Specification result (OOS) related to bacterial endotoxin testing
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
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Class II · last month
C.R. Bard Inc Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ recall: Due to complaints received indicating presence of contamination
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent…
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Class I · last month
Given Imaging Ltd. Bravo CF capsule delivery device, 5-pack recall: Capsule may fail to attach to the esophagus or detach from the delivery
Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of…
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Class II · last month
Nipro Renal Soultions USA, Corporation Citric Complete Dry Citric Acid Concentrate recall: Hemodialysis concentrates contain high endotoxin levels
Hemodialysis concentrates contain high endotoxin levels
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Class II · last month
C.R. Bard Inc Products that contain the Pericare Wipes: SureStep Intermittent recall: Due to complaints received indicating presence of contamination
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent…