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Mint Medical GmbH Friedrich-Ebert-Str. 2 Dossenheim Germany: mint Lesion, Software Versions: 3.9.0 through 3.9.5.

Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

Moderate

FDANov 15, 2024Nationwide• Mint Medical GmbH Friedrich-Ebert-Str. 2 Dossenheim Germany

CooperSurgical, Inc.: Brand Name: K-Systems Product Name: G73 Dry Bath Incubato...

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

Moderate

FDANov 15, 2024CA, DE, ID +12 more• CooperSurgical, Inc.

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Mint Medical GmbH Friedrich-Ebert-Str. 2 Dossenheim Germany: mint Lesion, Software Versions: 3.9.0 through 3.9.5.

CooperSurgical, Inc.: Brand Name: K-Systems Product Name: G73 Dry Bath Incubato...

L'Oven Fresh Keto Multiseed Tortillas (Rise Baking) – Metal Contamination (2024)

L'Oven Fresh Keto Original Tortillas (Rise Baking) – Metal Contamination (2024)

Duloxetine Capsules 30 mg (Amerisource) – Impurity Concern (2024)

Duloxetine Capsules 60 mg (Amerisource) – Impurity Concern (2024)

Esomeprazole Oral Suspension (Zydus) – Incorrect NDC Number (2024)

Duloxetine Capsules (Amerisource) – Impurity Limit Exceeded (2024)

Gelato Benzocaine Topical Gel (Keystone) – Manufacturing Defect (2024)

Benzo-Jel Topical Anesthetic Gel (Keystone) – Manufacturing Defect (2024)

Quala Dental Topical Anesthetic Gel (Keystone) – Manufacturing Defect (2024)

SensiCaine Ultra Topical Gel (Keystone) – Manufacturing Defect (2024)

Dental City Topical Anesthetic Gel (Keystone) – Manufacturing Defect (2024)

Health-Tec Topical Anesthetic Gel (Keystone) – Manufacturing Defect (2024)

Primo Topical Anesthetic Gel (Keystone) – Manufacturing Defect (2024)

Pearson Quality Topical Gel (Keystone) – Manufacturing Defect (2024)

Topical Anesthetic Gel (Keystone Industries) – CGMP Vessel Defect (2024)

Topical Anesthetic Gel (Keystone Industries) – CGMP Vessel Defect (2024)

Topical Anesthetic Gel (Keystone Industries) – CGMP Vessel Defect (2024)

Kirwan Surgical Products, LLC: Kirwan Surgical Products LLC Disposable 25-gauge bipolar ...