fda regulated Recalls

689 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Medtronic MiniMed Paradigm Revel Insulin Pumps Recalled: 26,647 Units Worldwide (2026)

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
All Medtronic
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Health & Personal Care
HIGH
FDA DEVICE

Medtronic MiniMed 720G Insulin Pump Recall 2026 Affects 37,458 Units Worldwide

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
All Medtronic
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Health & Personal Care
HIGH
FDA DEVICE

Medtronic MiniMed Paradigm Veo Insulin Pump Recalled for 55,724 Units (2026)

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
All Medtronic
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Health & Personal Care
HIGH
FDA DEVICE

Merit Medical ProGuide 16F Dialysis Sheath Introducer Recalled Worldwide in 2026 (131 Units)

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
16F dual-valved
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Health & Personal Care
HIGH
FDA DEVICE

Merit Medical BioFlo DuraMax Catheter Recall 2026: 47,153 Units Worldwide

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

Merit Medical Systems
16F dual-valved
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Health & Personal Care
HIGH
FDA DEVICE

Medtronic MiniMed Recalled 116,645 Insulin Pumps Over Delivery Risk (2026)

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
All Medtronic
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Health & Personal Care
HIGH
FDA DEVICE

Medtronic MiniMed 620G Insulin Pump Recall Impacts 799 Units Worldwide (2026)

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
All Medtronic
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Health & Personal Care
HIGH
FDA DEVICE

Medtronic MiniMed 700G Insulin Pump Recalled for Insulin Delivery Errors (13,811 Units, 2026)

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
All Medtronic
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Health & Personal Care
HIGH
FDA DEVICE

Medtronic MiniMed Paradigm Real-Time Insulin Pump Recalled for 29,074 Units Worldwide (2026)

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
All Medtronic
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Health & Personal Care
HIGH
FDA DEVICE

Medline ENFIT G-Tube Connector Kits Recalled for Leakage Risk in 2026

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.

Medline
Connectors were
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Health & Personal Care
HIGH
FDA DEVICE

Medtronic MiniMed 630G Insulin Pumps Recalled in 2026 for Insulin Delivery Errors (60,880 Units)

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
All Medtronic
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Health & Personal Care
HIGH
FDA DEVICE

Medtronic MiniMed 770G Insulin Pump Recall Affects 95,704 Units Worldwide (2026)

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 MiniMed
All Medtronic
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Health & Personal Care
HIGH
FDA DRUG

Harbin Jixianglong Biotech Semaglutide Rx Compounding Recall (2026)

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

Harbin Jixianglong Biotech Co.
CGMP Deviations
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Health & Personal Care
HIGH
FDA DRUG

Harbin Jixianglong Biotech Semaglutide Rx Compounding Recall 2026 — 6 Packaging Sizes

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.

Harbin Jixianglong Biotech Co.
CGMP Deviations
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Health & Personal Care
HIGH
FDA DRUG

AvKARE Recalls Amantadine HCl Capsules Over Dissolution Issues

AvKARE recalled Amantadine HCl capsules on February 13, 2026, due to failed dissolution specifications. The recall affects the 100 mg capsules, which may not dissolve properly. Consumers should stop using this product and contact their healthcare provider immediately.

AMANTADINE HCL
Failed Dissolution
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Health & Personal Care
HIGH
FDA DEVICE

Erbe USA Recalls 2,408 Flexible Cryoprobes for Surgery Over Rupture Risk (2026)

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
Probes
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Health & Personal Care
HIGH
FDA DEVICE

Olympus OER-Pro Endoscope Reprocessor Recall for 3,354 Units Over MAJ-1443/1444 Compatibility (2026)

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.

Olympus Corporation of the Americas
The MAJ-1443
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Health & Personal Care
HIGH
FDA DEVICE

Olympus MAJ-1443/MAJ-1444 Endoscope Suction Valves Recalled in 2026

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.

Olympus Corporation of the Americas
The MAJ-1443
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Health & Personal Care
HIGH
FDA DEVICE

Erbe USA Recall 33,390 Flexible Cryoprobes Over Rupture Risk (2026)

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.

Erbe USA
Probes
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Tag Statistics

Total Recalls
689

Related Tags

electronicbattery poweredlithium batteryimmediate actionstop use immediatelyreturn for refundreplacement availablecpsc regulatedglassinfant productadult productpet related