These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

3,615 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
HIGH
FDA DEVICE

See complete list in RES, exceeds character limit. Medline Surgical Gowns

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Medline Industries, LP
Medline has
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HIGH
FDA DEVICE

Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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

Medline Convenience Kits Recalled Over Sterility Issues

Medline recalled 5,346 convenience kits on January 7, 2026, due to sterilization calibration issues. The recall affects multiple model numbers, potentially compromising their sterility assurance. Healthcare providers and patients must stop using the products immediately.

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

Medline Recalls Neuro Shunt Kits Over Sterility Concerns

Medline Industries recalled 7,494 neuro shunt kits on January 7, 2026, due to sterilization calibration issues. These problems could compromise the sterility assurance level of the products. Patients and healthcare providers should stop using the affected devices immediately.

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

Medline Recalls Surgical Convenience Kits Over Sterility Issues

Medline Industries recalled 39,315 surgical convenience kits on January 7, 2026. Calibration issues in sterilization equipment may compromise the sterility of these devices. Healthcare providers and patients should stop using these products immediately.

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

Medline Recalls Surgical Gowns Due to Sterility Risk

Medline Industries, LP recalled over 70 million surgical gowns on January 7, 2026, due to sterilization calibration issues. These issues may compromise the sterility assurance level of the gowns, posing a potential health risk. Healthcare providers and patients should stop using these gowns immediately and follow the recall instructions.

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

Medline Recalls Burn Care Kits Due to Sterility Issues

Medline Industries recalled 291 units of burn care kits on January 7, 2026. Calibration issues with sterilization equipment may compromise product sterility. Users should stop using the affected products immediately.

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

Medline Recalls Lithotomy Packs Over Sterility Concerns

Medline Industries recalled 808 lithotomy packs on January 7, 2026, due to calibration issues in sterilization equipment. These problems may compromise the sterility assurance level of the products. Healthcare providers and patients must stop using these devices immediately.

Medline Industries, LP
Medline has
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HIGH
FDA DEVICE

Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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

Philips Recalls IQon Spectral CT Over Potential Rotor Hazards

Philips North America recalled 52 units of the IQon Spectral CT on January 7, 2026, due to fasteners that may not be torqued to specification. This defect may lead to unsecured rotor parts during operation. No injuries have been reported, but the potential for parts to be expelled during gantry rotation poses a safety risk.

Philips North America
As part
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HIGH
FDA DEVICE

Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;

If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.

Mint Medical GmbH
If the
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Health & Personal Care
HIGH
FDA DEVICE

Medline PPE Kits Recalled Due to Sterilization Issues

Medline Industries recalled 7,575 PPE kits on January 7, 2026, due to calibration problems affecting sterilization. The recall involves model number DYK1011945P, distributed worldwide. Users should stop using the affected kits immediately and follow manufacturer instructions.

Medline Industries, LP
Medline has
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HIGH
FDA DEVICE

Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST-LF, Model Number: DYNJ83950; 3) HERNIA REPAIR TOTE, Model Number: DYNJ908337A; 4) HERNIA...

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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

Medline Surgical Kits Recalled Over Sterility Concerns

Medline Industries recalled 82,597 surgical kits on January 7, 2026, due to issues with sterilization calibration. The defect may compromise sterility assurance levels of the products. Healthcare providers and patients should stop using these kits immediately.

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

Medline Recalls Admission Kits Over Sterility Concerns

Medline Industries recalled 1,070 ADMIT KITS due to calibration issues affecting sterilization. The recall, effective January 7, 2026, has been classified as Class II. Healthcare providers must stop using these kits immediately to ensure patient safety.

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

Medline Drape Pack Recalled Over Sterility Concerns

Medline Industries recalled 72 units of Drape Pack-Choice, Model DYNJ63118A, on January 7, 2026. Calibration issues in sterilization equipment may compromise product sterility. Patients and healthcare providers should stop using the device immediately.

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

Medline Recalls Convenience Kits Over Sterility Concerns

Medline recalled 553 units of its Convenience Kits on January 7, 2026. Calibration issues with sterilization equipment may compromise product sterility. Healthcare providers and patients must stop using the affected devices immediately.

Medline Industries, LP
Medline has
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HIGH
FDA DEVICE

Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK,...

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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

Olympus Recalls Sphincterotome Due to Deformation Risk

Olympus Corporation of the Americas recalled 1,025 units of its Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform due to inadequate thermoforming, posing a high hazard level. Patients and healthcare providers must stop using the devices immediately and follow recall instructions.

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

Medline Recalls Tracheostomy Kits Over Sterility Concerns

Medline Industries recalled 753 tracheostomy kits on January 7, 2026, due to calibration issues in sterilization equipment. The defect may compromise the sterility assurance level of the devices. Users should stop using these products immediately and follow the recall instructions.

Medline Industries, LP
Medline has
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