Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
PREGNANCY TEST 24CT
Potential exposure of rodents and rodent activity in the distribution center.
Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL P...
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. M...
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KI...
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Ele...
Due to a manufacturing issue and electrical grounding of systems.
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: ...
Incorrect expiration date
Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit...
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24...
Potential exposure of rodents and rodent activity in the distribution center.
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR syst...
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW...
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R...
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material N...
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR...
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDO...
Potential exposure of rodents and rodent activity in the distribution center.
AlternatiV+ Max Knotless Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11....
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN D...
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW vers...
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010
Incorrect expiration date
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW...
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit...
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed