Recalls affecting South Carolina
Notices that name South Carolina in their distribution area, plus every nationwide recall — nationwide recalls reach South Carolina too.
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Class II · last month
Bayer Medical Care, Inc. Medrad¿ Stellant Flex Syringe Kit used with Stellant Flex CT recall: Some devices may not have been properly sterilized due to a manufacturing
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
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Class II · last month
Pi Cardia Ltd Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US recall: Transfemoral catheter, positing arm may detached due to weld issue
Transfemoral catheter, positing arm may detached due to weld issue.
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Class II · last month
GE Healthcare Centricity PACS V2, V3, V4, V6, V7, software product is intended 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
Stryker Sustainability Solutions REF:B5LT 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
Howmedica Osteonics Corp. Acetabular CUP Uhmwpe 61-3258 ALL Poly Constrained Insert 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…
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Class II · last month
Howmedica Osteonics Corp. ABG I Acetabular Insert Hooded 28mm ID X 48mm C-M079-2-801 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…
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Class II · last month
Mirion Technologies , Inc. Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151 recall: Potential for failure of the tension bolt which would allow the spring arm
Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25…
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Class II · last month
Stryker Sustainability Solutions REF:B5ST 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
F & A Foundation Reign Medical Clench Staple System , Description/REF: 9mm x recall: Bone fixation staple requires a new 510(k); the performance characteristics
Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
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Class II · last month
Howmedica Osteonics Corp. Scorpio C-Dome Patella 73-2710 73-2910 Scorpio U-Dome 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…
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Class I · last month
Medline Convenience Kits: 1) KIT Anesthesia L&D A- Line SET 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 II · last month
Philips PIC iX Essentials REF:867093 recall: Due to software malfunction, patient information system may freeze and become
Due to software malfunction, patient information system may freeze and become unresponsive.
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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
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
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…