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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2111) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Medline Industries is recalling Medline Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance.
Windstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kits (Part Number AMS14994A) due to a potential for backflow of medication from secondary IV containers into primary IV containers. The recall affects 520 units distributed nationwide.
FDA has rescinded the 510(k) clearances for certain Medline medical device kits including control syringes, guidewires, and high-pressure tubing. Medline is recalling approximately 58,836 units distributed nationwide.
SurgiSmoke Solutions is recalling certain lots of Flamingo Funnel Medium (Model SQ20012-02) because a non-gamma sterilization compatible drape was used during manufacturing, which could affect device safety.
Medline Industries has issued a recall of Medline Namic Guidewires because their FDA 510(k) regulatory clearances have been rescinded. The affected units were distributed nationwide.
B. Braun is correcting gravity and pump administration sets used with specific infusion pumps due to risk of medication backflow from secondary containers into primary containers and occlusion during priming.
The FDA has rescinded regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing included in Medline's Arthroscopy Pack (Model DYNJ82440). Affected units should not be used.
Medline Industries is recalling certain surgical and medical kits because their 510(k) regulatory clearances for Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. About 2,609 units were distributed nationwide.
Medline Industries is recalling three ENT and vascular kits (513 units nationwide) because their regulatory clearances for certain components—Control Syringes, Guidewires, and/or High-Pressure Tubing—have been rescinded.
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2117) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Medline Industries is recalling Heart Transplant Biopsy Kit (Model DYNJ37543A) after the FDA rescinded regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing used in the kit.
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2110) because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The tubes are used to reprocess endoscopes.
Arrow International is recalling 395 pressure injectable central venous catheters across nine U.S. states due to incorrect manufacturing of the liquid adhesive by a supplier.
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects syringes distributed worldwide, including the US, Canada, Panama, and Barbados.
Olympus Corporation recalls OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2115) due to a defect. The recall affects approximately 2,089 units distributed nationwide and internationally.
Micro-X Ltd. is recalling certain Rover Mobile X-ray Systems (models MXU-RV35 and MXU-RV71) because the X-ray generator may malfunction, rendering the device inoperable.
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2112) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance.
Arrow International is recalling the Arrowgard Blue MAC Two-Lumen Central Venous Access Kit due to incorrect manufacturing of the liquid adhesive by a supplier. The recall affects 95 units distributed in nine U.S. states.
Arrow International is recalling 85 units of the Arrow Echogenic Introducer Needle due to incorrect manufacturing of the liquid adhesive used in the device.
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Large (Model SQ20012-03) surgical device due to a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Medline Industries is recalling certain Angio Cath Pack kits (Model DYNJ24517D, Lot 25CBA224) because their regulatory 510(k) clearances have been rescinded by the FDA.
Medline Industries has recalled multiple control syringes, guidewires, and high-pressure tubing models because their FDA 510(k) regulatory clearances have been rescinded. The recall affects 38,230 units distributed nationwide.
Medline Industries has recalled the GYN Laparoscopy Pack (Model DYNJ41257F, Lot 25GBL423) because its regulatory clearances for certain components—including Control Syringes, Guidewires, and High-Pressure Tubing—have been rescinded.
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