Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 9 months ago
Medline medical procedure convenience kits labeled as: Head Shave-Latex recall: Medline kits were manufactured and distributed containing MASTISOL liquid
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing…
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Class II · 9 months ago
Medline medical procedure convenience kits labeled as: 1) Inpatient recall: Medline kits were manufactured and distributed containing MASTISOL liquid
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing…
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Class II · 9 months ago
Aju Pharm Co., Ltd. Fixone Hybrid Anchor recall: Reports of device failure, including anchor breakage, anchor bending
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
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Class II · 9 months ago
Aju Pharm Co., Ltd. Fixone Biocomposite Anchor recall: Reports of device failure, including anchor breakage, anchor bending
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
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Class II · 9 months ago
Miach Orthopaedics BEAR Implant recall: Incorrect expiration date on label that extends beyond the product's
Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will…
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Class II · 9 months ago
Philips North America Evolution Upgrade 1.5T. Product Codes : 782148 recall: The potential for stiffness value errors when viewing exported MR
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication…
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Class II · 9 months ago
Medline medical procedure convenience kits labeled as: 1) SMJ LAP Chole recall: Medline kits were manufactured and distributed containing MASTISOL liquid
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing…
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Class II · 9 months ago
Medline medical procedure convenience kits labeled as: 1) recall: Medline kits were manufactured and distributed containing MASTISOL liquid
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing…
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Class I · 9 months ago
SunMed Holdings, LLC Brand Name: Broselow Product Name: Broselow Pediatric Emergency recall: Product contains potentially harmful dosing errors for Vecuronium
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
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Class II · 9 months ago
Siemens Medical Solutions USA, Inc Interventional Fluoroscopic X-Ray System: Luminos recall: Ortho images acquired with preset automatic horizontal flip are not flipped
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image…
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Class II · 9 months ago
Philips North America Ingenia Ambition S. Product Code : 782108. MR systems with SW recall: The potential for stiffness value errors when viewing exported MR
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication…
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Class II · 9 months ago
Aju Pharm Co., Ltd. Genesis Push-In Suture Anchor recall: Reports of device failure, including anchor breakage, anchor bending
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
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Class II · 9 months ago
Philips North America SmartPath to dStream for 3.0T. Product Code : 782145. MR systems recall: The potential for stiffness value errors when viewing exported MR
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication…
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Class II · 9 months ago
Medline medical procedure convenience kits labeled as: Nerve Block Tray recall: Medline kits were manufactured and distributed containing MASTISOL liquid
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing…
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Class II · 9 months ago
Aju Pharm Co., Ltd. AlternatiV+ Screw-In Anchor recall: Reports of device failure, including anchor breakage, anchor bending
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
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Class II · 9 months ago
Medline medical procedure convenience kits labeled as: 1) Watkins Spine recall: Medline kits were manufactured and distributed containing MASTISOL liquid
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing…
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Class II · 9 months ago
LSL Healthcare, Central Line Dressing Kit, Model/ recall: BD ChloraPrep Triple Swabsticks, a component within the kits
BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.
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Class II · 9 months ago
GVS TM, Inc SQ40S Blood Transfusion Filter recall: Due to products being released for distribution prior to completion
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be…
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Class II · 9 months ago
Brand Name: EDAN Product Name: Patient Monitor Model/ recall: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm…
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Class I · 9 months ago
Medline beds labeled as: 1) Semi Electric Basic Homecare Bed recall: Medline Industries has identified a potential hazard involving the hand
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as…
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Class II · 9 months ago
Brand Name: EDAN Product Name: Patient Monitor Model/ recall: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm…
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Class II · 9 months ago
Community Products, LLC Rifton Equipment, Low Base TRAM. Model/ recall: Potential for fraying on the body support strap
Potential for fraying on the body support strap.
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Class II · 9 months ago
Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/ recall: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm…
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Class II · 9 months ago
Raysearch Laboratories Ab RayStation/RayPlan. Model/ recall: Potential for the invalidation for calculated radiation dose does not work
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for…