infant product Recalls

228 recalls tagged with “infant product”.

Health & Personal Care
HIGH
FDA DEVICE

Mentor Texas CPX 4 US Breast Tissue Expanders Recall 2026

Mentor Texas, LP recalled CPX 4 US Breast Tissue Expanders with Suture Tabs worldwide on February 18, 2026. The recall covers models SCPX-107MH, SCPX-117MH, SCPX-127MH, SCPX-135MH, SCPX-146MH and SCPX-156MH. Infusion sets may include a dull needle tip that is difficult to advance and may break. Stop using the device and follow recall instructions from the manufacturer, with recall notification by-

Mentor Texas
Infusion sets
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Food & Beverages
HIGH
FDA FOOD

Sunflour Bakery Recalls 1 Bag Hamburger Bun Over Undeclared Sesame Seed (2026)

Sunflour Bakery recalled 1 bag of Hamburger Bun, 18oz with six buns sold to a single Orange County retailer. The recall involves sesame seeds not declared on the label. Consumers should not eat the product and should contact Sunflour Bakery by email for refund or replacement.

NRS Enterprises, Inc. dba Sunflour Bakery
Undeclared sesame
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls 14,379 Olympus Biopsy Valve Kits in 2026

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
Kits contain
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Health & Personal Care
HIGH
FDA DEVICE

Medline Airway Exam Kit Recalled for 14,379 Units Over Olympus Valve Detachment (2026)

Medline Industries, LP recalled 14,379 Airway Exam Kits containing Olympus biopsy valves nationwide. The recall cites rubber fragments detaching from the slit of single-use biopsy valves. Potential harm includes a foreign body in the patient’s tracheobronchial tree, inflammatory response, hypoxia, and longer procedures. Providers and patients should stop using the kit and follow recall directions.

Medline Industries, LP
Kits contain
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Health & Personal Care
HIGH
FDA DEVICE

Abiomed Impella Automated Controller Recall 62 Units in 2026

Abiomed recalled 62 Automated Impella Controller units sold to hospitals internationally. The recall warns of a delayed Purge System Blocked alarm display when used with first generation Impella 5.5 pumps. Hospitals should stop using the device immediately and contact Abiomed for instructions.

Abiomed
Potential that
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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

Medtronic MiniMed 530G Insulin Pumps Recalled for Delivery Errors in 2026 (13,429 Units)

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.

Medtronic MiniMed
All Medtronic
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Health & Personal Care
HIGH
FDA DEVICE

Medline ENFIT G-Tube Connector ENFIT1010GC Recalled for Leakage Risk (651,789 Units, 2026)

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

Medline Industries
Connectors were
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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

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 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 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 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

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

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

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

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 MAJ-1444 Endoscope Air/Water Valve Recall 2026 for 89,579 Units

Olympus Corporation of the Americas is recalling 89,579 MAJ-1444 endoscope air/water valves distributed nationwide in the United States. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Healthcare facilities should stop using the devices 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

Waldemar Link Embrace Drill Tower Recall 74 Units in 2026

Waldemar Link GmbH & Co. KG recalls 74 Embrace Drill Tower devices distributed in 15 U.S. states. The recall notes mixed-up article numbers in the overview of the instruments. The surgical steps are correct. Stop using the device immediately and follow manufacturer instructions.

Waldemar Link GmbH & Co. KG
The surgical
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Tag Statistics

Total Recalls
228

Related Tags

laceration riskfda regulatedcpsc regulatedimmediate actionreturn for refundadult productglassplasticmetalsuffocation riskelectrical hazardchemical hazard