burn risk Recalls

425 recalls tagged with “burn risk”.

Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Over Deformation Risk

Olympus Corporation of the Americas recalled 17,655 sphincterotomes on January 7, 2026. The devices may deform due to improper thermoforming, affecting performance. Patients and healthcare providers must stop using the devices immediately.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Medline Convenience Kits Recalled Due to Sterility Issues

Medline Industries has recalled 779 units of its Convenience Kits due to calibration issues with sterilization equipment. The recall affects multiple model numbers including DYNJ56436A and DYNJ56436B. Consumers should stop using these products immediately and follow recall instructions.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to High Hazard Risk

Olympus Corporation recalled 887 units of the Disposable Triple Lumen Sphincterotome on January 7, 2026. The devices may deform and lose performance if not properly thermoformed. The recall affects both US and international markets.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Over Potential Performance Issues

Olympus Corporation of the Americas recalled 1,980 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall affects devices that did not undergo thermoforming, risking deformation and loss of performance. Healthcare providers must stop using these devices immediately.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to High Risk of Deformation

Olympus Corporation of the Americas recalled 125 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall affects devices that did not undergo proper thermoforming, risking deformation and performance loss. Healthcare providers must stop using these devices immediately.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Sphincterotome Recalled Due to Deformation Risk

Olympus Corporation of the Americas recalled 7,689 Disposable Triple Lumen Sphincterotomes on January 7, 2026. The devices may deform due to inadequate thermoforming, risking performance failure during medical procedures. Healthcare providers must stop using these devices immediately and follow recall instructions.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Over Risk of Deformation

Olympus Corporation of the Americas recalled 1,490 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The devices may deform due to improper thermoforming, risking performance failure. Healthcare providers should immediately stop using these devices and follow recall instructions.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Performance Risks

Olympus Corporation of the Americas recalled 886 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall follows reports that devices not properly thermoformed could deform and lose performance. Patients and healthcare providers should stop using the device immediately.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Performance Risk

Olympus Corporation of the Americas recalled 33,433 units of its Single Use 3-Lumen Sphincterotome V on January 7, 2026. Devices that did not undergo thermoforming may deform and lose performance, posing a high risk to patients. Healthcare providers and patients should stop using the device immediately.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Hazardous Deformation Risk

Olympus Corporation of the Americas recalled 65,117 Single Use 3-Lumen Sphincterotome V devices on January 7, 2026. Improper thermoforming may cause the devices to deform and lose performance. Users should stop using the device immediately and follow the manufacturer’s instructions.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Performance Risk

Olympus Corporation of the Americas recalled 7,046 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall affects devices that did not undergo proper thermoforming, risking deformation and performance loss. Healthcare providers and patients must stop using these devices immediately.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Risk of Deformation

Olympus Corporation of the Americas recalled 2,344 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform due to improper thermoforming, leading to performance issues. This recall affects units distributed worldwide, including all U.S. states.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Surgical Kits Over Sterility Concerns

Medline Industries recalled 12,418 surgical kits on January 7, 2026, after identifying calibration issues in sterilization equipment. The defects could compromise sterility assurance levels of the devices. Healthcare providers and patients must stop using the affected products immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Medline Surgical Kits Recalled Over Sterilization Issues

Medline Industries recalled 4,415 surgical kits on January 7, 2026, due to sterilization calibration issues. These issues could compromise the sterility assurance level of the products. Healthcare providers and patients must stop using the kits immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

VANTIVE US HEALTHCARE Recalls Dialyzer Over Dislodgement Risk

VANTIVE US HEALTHCARE recalled 115,112 units of the PRISMAFLEX HF1000 SET on January 6, 2026. The recall stems from a potential dislodgement of the deaeration chamber from the control unit. Healthcare providers and patients must stop using the device immediately.

VANTIVE US HEALTHCARE
There is
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Health & Personal Care
HIGH
FDA DEVICE

VANTIVE US HEALTHCARE Recalls Dialyzer Due to Dislodgement Hazard

VANTIVE US HEALTHCARE recalled 87,436 Prismaflex ST100 Dialyzers on January 6, 2026. The recall follows reports of potential dislodgement of the deaeration chamber from the control unit. Healthcare providers and patients must stop using the device immediately.

VANTIVE US HEALTHCARE
There is
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Health & Personal Care
HIGH
FDA DEVICE

Straumann USA Recalls Impression Caps Over Mix-Up Hazard

Straumann USA recalled 561 units of its Impression Post Closed Tray on January 6, 2026. The recall occurred due to a mix-up where impression caps were mistakenly packaged in magenta instead of the intended brown. Healthcare providers and patients must stop using the device immediately.

Straumann USA
The mix
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Health & Personal Care
HIGH
FDA DEVICE

Medline Nail Kit Recalled Over Sterility Concerns

Medline Industries recalled 1,640 units of its Nail Kit, Model POD14214, on January 5, 2026. The recall stems from concerns that the sterile saline wound wash may not meet required sterility standards. Patients and healthcare providers must stop using the product immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Miach Orthopaedics Recalls BEAR Implant Over Expiration Date Error

Miach Orthopaedics recalled 284 units of the BEAR Implant, Model Number 1000, on December 31, 2025. The recall stems from an incorrect expiration date on the label that exceeds the product's approved shelf life. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

Miach Orthopaedics
Incorrect expiration
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Health & Personal Care
HIGH
FDA DRUG

GOLD STAR DISTRIBUTION Vaporizing Chest Rub Recall 2026 All Lots Nationwide

Gold Star Distribution is recalling all lots of its Vaporizing Chest Rub, 4 oz, 12-count, UPC 048155903319, distributed nationwide in the United States. The recall, number D-0283-2026, stems from CGMP deviations including insanitary conditions with rodent exposure/activity at the distribution center. Consumers and healthcare providers should stop using the product immediately and contact Gold Star

Gold Star Distribution
CGMP Deviations:
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