Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114...
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR1...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS C...
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultr...
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)1080...
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119...
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DY...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHET...
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
The product is a handheld ultraviolet-C germicidal wand and contains a combinati...
In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-05...
Potential for detachment of a distal tip component of the device during use.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18...
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117...
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.