689 recalls tagged with “fda regulated”.
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.
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 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 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 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.
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.
Harbin Jixianglong Biotech Co. recalled Semaglutide for Rx compounding use nationwide in the United States. The recall cites CGMP deviations and failure to complete endotoxin validation before distribution. Healthcare providers and patients should stop using the product immediately and contact the company or a healthcare provider for guidance via email.
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 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,
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.
Harbin Jixianglong Biotech Co. recalled semaglutide for Rx compounding use distributed nationwide to healthcare providers in the United States. The recall cites CGMP deviations and failure to complete process validation and bacterial endotoxin method validation before distribution. Healthcare providers and patients should stop using this product immediately and contact the manufacturer or their CL
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 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.
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.
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.
Olympus Corporation of the Americas recalled 3,354 units of the OER-Pro endoscope reprocessor on February 12, 2026. MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Hospitals and clinics should stop using the device immediately and follow the manufacturer’s recall instructions.
Erbe USA recalled 33,390 Flexible Cryoprobes with oversheath used in surgery. The devices were distributed nationwide, including Puerto Rico. Probes may rupture during activation. Clinicians should stop using the device immediately and follow recall instructions.
Olympus Corporation of the Americas recalls 47,383 MAJ-1443 and MAJ-1444 endoscope suction valves distributed nationwide in the United States. The valves are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Hospitals and clinics should stop using the valves immediately and follow the manufacturer’s recall instructions.
Erbe USA recalled 2,408 Flexible Cryoprobes (REF 20402-411) used in surgery nationwide, including Puerto Rico. Probes may rupture or burst during activation. Hospitals and healthcare providers should stop using the device and follow recall instructions. Manufacturer contact will provide remediation.
Erbe USA recalled 5,154 Flexible Cryoprobes used in surgery after probes may rupture during activation. The defect can cause rupture or burst during activation. Stop using the device and follow recall instructions from the manufacturer.