2,756 recalls tagged with “immediate action”.
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.
Medtronic recalled 453,144 MiniMed 780G insulin pumps worldwide after reports of unintended insulin delivery when the pump height changes relative to the infusion site. The defect stems from gravity-driven pressure changes affecting hydrostatic delivery. Patients and caregivers should stop using the devices immediately and follow the recall notice, contacting Medtronic MiniMed or their clinician’s
Medtronic recalled 13,429 MiniMed insulin pumps worldwide after identifying unintended insulin delivery errors. The issue occurs when the pump height relative to the infusion site changes, causing over-delivery or under-delivery of insulin. Patients should stop using the device and contact Medtronic 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 131 units of the ProGuide chronic dialysis catheter introducer worldwide after a design defect could prevent the device from splitting as intended. The defect may cause hemorrhage, retained foreign bodies, and delays to procedures. Healthcare providers should stop using the device and follow the manufacturer’s recall instructions.
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 116,645 MiniMed 640G insulin pumps worldwide, including the United States. The devices can deliver too much or too little insulin when the pump height changes relative to the infusion site due to gravity-driven pressure shifts. Stop using the pump immediately and contact Medtronic MiniMed or your healthcare provider for guidance.
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.
Medtronic MiniMed recalled 73,656 Paradigm insulin pumps sold worldwide, including broad U.S. distribution, after a risk of unintended insulin delivery. The issue affects Paradigm, 600-series and BLE 700-series pumps. It can cause life-threatening highs or lows in insulin delivery. Stop using the device and follow recall instructions immediately.
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.