1,716 recalls tagged with “cpsc regulated”.
Medline Industries is recalling 14,379 kits nationwide that include Olympus biopsy valves. The recall follows reports of rubber fragments detaching from the valves during use. Healthcare providers and patients should stop using the affected kits and follow Medline’s recall instructions.
Medline Industries is recalling 14,379 bronchoscopy kits containing Olympus biopsy valves distributed nationwide in the United States. Olympus reports rubber fragments detaching from the valve slit, which could leave a foreign body in a patient’s tracheobronchial tree and may require removal. Hospitals should stop using the affected kits immediately and follow Medline’s recall instructions.
Olympus biopsy valves in Medline Industries, LP thoracic robotic biopsy valve kits are recalled nationwide. The recall covers 14,379 kits distributed across 13 states. Rubber fragments may detach from single-use biopsy valves, creating a risk of a foreign body in the patient’s tracheobronchial tree and possible inflammation or hypoxia. Healthcare providers and patients should stop using the device
Medline Industries, LP recalled 14,379 kits nationwide that include Olympus biopsy valves. The recall concerns rubber fragments detaching in the slit of single-use biopsy valves. Stop using these kits immediately and follow manufacturer instructions for return or replacement.
Medline Industries, LP recalled 14,379 Olympus biopsy valve kits sold nationwide to hospitals and clinics. Olympus biopsy valves in the kits may detach rubber fragments from the valve slit. Hospitals and clinics should stop using the devices immediately and follow the recall instructions.
Merit Medical Systems has issued an active recall affecting 35,591 CentrosFLO Hemodialysis Catheters sold worldwide. The recall centers on a 16F dual-valved splittable sheath introducer that may fail to split as intended. This failure can cause hemorrhage, foreign-body retention, and procedure delays. Healthcare providers should stop using the device and follow Merit Medical's recall instructions.
Merit Medical Systems recalls 368,264 units of the 16F Dual-Valved Splittable Sheath Introducer bulk non-sterile sold worldwide. A design defect may prevent the sheath from splitting as intended, risking hemorrhage and foreign bodies. Healthcare providers should stop using the device and contact Merit Medical for instructions.
Merit Medical Systems recalled 21,591 DuraMax chronic hemodialysis catheters worldwide. The devices use a 16F dual-valved splittable sheath introducer that may not split as intended, risking hemorrhage and procedure delays. Clinicians should stop using the devices immediately and follow the recall instructions.
Medline Industries recalled 651,789 ENFIT G-TUBE connectors (ENFIT1010GC) sold worldwide, including the United States and Canada. The connectors were not manufactured to required dimensional specifications and may not seal properly with ENFit-style devices, which could lead to leakage. Healthcare facilities and patients should stop using this device immediately and follow recall instructions from
Medtronic MiniMed recalled 24,946 MiniMed 740G insulin pumps worldwide after identifying unintended insulin delivery when the pump height changes relative to the infusion site. The defect can cause over-delivery or under-delivery of insulin due to gravity-driven pressure changes. Patients should stop using the device and contact Medtronic MiniMed for instructions on recall steps, refunds or a swap
Medtronic MiniMed recalled 26,647 Paradigm REAL-Time Revel insulin pumps distributed worldwide, including in the United States. A design flaw can cause insulin to be over- or under-delivered when the pump height changes relative to the infusion site. Patients and health providers should stop using the device immediately and follow the manufacturer’s recall instructions. The recall covers Paradigm,
Medtronic MiniMed recalled 37,458 insulin pumps sold worldwide through healthcare providers, including the MiniMed 720G, after finding that a pump raised above or lowered relative to the infusion site can deliver insulin too much or too little. The defect stems from changes in gravitational force affecting hydrostatic and hydrodynamic pressures at the infusion site. Patients should stop using the
Medtronic MiniMed recalls 55,724 Paradigm REAL-Time Veo insulin pumps distributed worldwide. The pumps can deliver too much insulin when raised or too little when lowered relative to the infusion site due to gravity-driven pressure changes. Patients should stop using the device and contact Medtronic MiniMed or their healthcare provider for instructions and refunds.
Merit Medical Systems recalled 47,153 BioFlo DuraMax Catheters distributed worldwide through medical distributors after a design defect in the 16F dual-valved splittable sheath introducer may fail to split as intended. The defect can cause hemorrhage, foreign bodies, and delays in procedures. Clinicians and patients should stop using the device immediately and follow recall instructions from Merit
Medtronic MiniMed recalled 799 infusion pumps worldwide, including in the United States. The devices in the Paradigm, 600, and BLE 700 series can deliver too much or too little insulin when their height relative to the infusion site changes due to gravity. Stop using the pump immediately and contact Medtronic MiniMed for instructions on replacement or refund.
Medtronic MiniMed recalled 13,811 MiniMed 700G insulin pumps sold worldwide through multiple retailers. The pumps can deliver too much or too little insulin when the pump height relative to the infusion site changes due to gravity. Consumers should stop using the device and follow recall instructions in the letter notice sent to affected users.
Medtronic MiniMed recalled 29,074 Paradigm Real-Time insulin pumps worldwide. The devices may deliver insulin improperly when the pump is elevated or lowered relative to the infusion site due to gravitational effects. Patients should stop using the pumps immediately and follow recall instructions from the manufacturer and their healthcare provider.
Medline recalled 9,040 ENFIT G-Tube Connector kits sold worldwide, including the US and Canada. The connectors were not manufactured to required dimensional specifications and may not seal properly with ENFit devices, potentially causing leakage. Stop using the kits immediately and follow recall instructions from Medline or your healthcare provider.
Medtronic MiniMed recalled 60,880 insulin pumps sold worldwide through healthcare providers and medical distributors, including the MiniMed 630G line. The defect is gravity related and can cause insulin over-delivery or under-delivery when the pump height changes relative to the infusion site. Patients should stop using the pumps immediately and follow recall instructions.
Medtronic MiniMed recalled 95,704 MiniMed 770G insulin pumps worldwide after finding insulin delivery can misbehave when the pump height changes. Over-delivery can cause severe hypoglycemia and death; under-delivery can cause hyperglycemia and death. Stop using the device and follow the manufacturer’s recall instructions immediately.