Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class I · last month
Medical Action Industries, Inc. 306 Kit: Epidural/Pain TQC 20/Cs recall: Kits containing Sodium Chloride ampules subject to another recall
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
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Class II · last month
AVID Medical, Inc. Halyard IV Start Kit Non-Sterile REF: KRIV26-02 recall: Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the…
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Class I · last month
Medical Action Industries, Inc. 306 Kit: Single Shot Epidural 20/Cs, REF: 59553 recall: Kits containing Sodium Chloride ampules subject to another recall
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
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Class II · last month
Windstone Medical Packaging, Inc. AMS Convenience Kit: DSAEK Pack - RX recall: The convenience kits contain .0.9% Sodium Chloride Injection
The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts…
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Class II · last month
Nipro Renal Soultions USA, Corporation MedicaLyte Bicarbonate Powder REF: DB+201-2.1 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" Foley Tray System 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 II · last month
Nipro Renal Soultions USA, Corporation Citric Complete Liquid Citric Acid Concentrate recall: Hemodialysis concentrates contain high endotoxin levels
Hemodialysis concentrates contain high endotoxin levels
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Class II · last month
Atrium Medical Corporation Getinge PVC Thoracic Catheter, Firm PVC Straight 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 Lubricath Foley 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 II · last month
HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes recall: Due to a damaged (over stretched) membrane tail that causes an intermittent
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
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Class II · last month
C.R. Bard Inc Products that contain the Pericare Wipes: Bard¿ Foley Tray 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 II · last month
Atrium Medical Corporation Getinge PVC Thoracic Catheter, Soft PVC Straight 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: SureStep" Foley Tray System 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 II · last month
Lutronic Corporation Product Name: DermaV Laser System Model/ recall: Utilizing higher fluences at 1064nm wavelength with current cryogen
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially…
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Class II · last month
Nipro Renal Soultions USA, Corporation MedicaLyte Liquid Bicarbonate Concentrate REF recall: Hemodialysis concentrates contain high endotoxin levels
Hemodialysis concentrates contain high endotoxin levels
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Class II · last month
Medline Convenience Kits: 1) Blood Draw KIT recall: The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to…
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Class II · last month
Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within recall: The Urinary Catheter Trays contain CliniClean Pericare Wipes
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing…
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Class II · last month
Medline recall: Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an…
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Class II · last month
Medline Convenience Kits: 1) Ortho Aspiration KIT recall: The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to…
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Class II · last month
AVID Medical, Inc. 1) Neuro, Acne73-01 recall: The recall notice was initiated due to a Medicom Urgent Medical Device
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges…
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Class II · last month
Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within recall: The Urinary Catheter Trays contain CliniClean Pericare Wipes
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing…
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Class II · last month
Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within recall: The Urinary Catheter Trays contain CliniClean Pericare Wipes
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing…
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Class II · last month
Boston Scientific Corporation Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac recall: There is potential for a delay in AF Burden Alert notification affecting
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs)…
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Class II · last month
Medline recall: Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an…