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Showing 2661–2680 of 3039 results

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Monterey AL Implant Inserter (Stryker) – Unlock Button Separation (2025)

Potential for the gold unlock button to separate from the inserter.

FDAFeb 28, 2025CA, CO, FL +10 more• Stryker Spine

Duloxetine Capsules 20mg (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Class IIModerate

FDAFeb 28, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Carvedilol Tablets 25mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 12.5mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Spectral CT on Rails (Philips) – Software Scanning Problems (2025)

Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.

FDAFeb 28, 2025MN• Philips Medical Systems Nederland B.V. Veenpluis

Monterey AL Implant Inserter (Stryker) – Unlock Button Separation (2025)

Potential for the gold unlock button to separate from the inserter.

FDAFeb 28, 2025CA, CO, FL +10 more• Stryker Spine

Walgreens Acne Control Cleanser (Sigan) – Benzene Contamination (2025)

Chemical Contamination: Presence of benzene

Class IIModerate

FDAFeb 28, 2025Nationwide• Sigan Industries Group Inc.

Carvedilol Tablets 3.125mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Phoroptor VRx Digital Refraction System (Reichert) – Head Detachment Risk (2025)

The head of the phoropter head could come loose and potentially detach due to a default in the assembly.

FDAFeb 28, 2025Nationwide• Reichert, Inc.

Tandem Mobi Insulin Pump (Tandem Diabetes) – Software Defect (2025)

A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.

FDAFeb 27, 2025AZ, CA, CO +26 more• Tandem Diabetes Care, Inc.

NexGen LPS Flex Knee Joint (Zimmer) – Labeling Compatibility Error (2025)

The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.

FDAFeb 27, 2025Nationwide• Zimmer, Inc.

MyDay Toric Contact Lenses (CooperVision) – Incorrect Cylinder Power (2025)

a limited number of lots were manufactured with an incorrect cylinder power.

FDAFeb 27, 2025CA, CO, FL +12 more• CooperVision, Inc.

Neupogen 480mcg (Amgen) – Stability Expiration Issue (2025)

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

Class IIModerate

FDAFeb 27, 2025Nationwide• Amgen, Inc.

t:slim X2 Insulin Pump (Tandem Diabetes) – Software Defect (2025)

A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.

FDAFeb 27, 2025AZ, CA, CO +26 more• Tandem Diabetes Care, Inc.

Access Vitamin B12 Reagent (Beckman Coulter) – Result Accuracy (2025)

Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.

FDAFeb 27, 2025Nationwide• Beckman Coulter, Inc.

Solo Diamond Cone (Premier Dental) – Material Hardness Issue (2025)

The hardness not meeting the material specification and may cause the diamond bur to bend.

FDAFeb 27, 2025Nationwide• Premier Dental Products Co

Neupogen 300mcg (Amgen) – Stability Expiration Issue (2025)

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

Class IIModerate

FDAFeb 27, 2025Nationwide• Amgen, Inc.

FilmArra Pneumonia Panel (BioFire) – Test Result Reliability (2025)

Increased risk of control failures and false negative test results with multiplexed nucleic acid test.

FDAFeb 27, 2025Nationwide• BioFire Diagnostics, LLC

Hippo 072 Aspiration System (Qapel) – Catheter Tip Defect (2025)

Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.

FDAFeb 26, 2025AL, AZ, CA +26 more• Qapel Medical Inc.

DxC 500 AU Clinical Chemistry Analyzer (Beckman Coulter) – Software Defect (2025)

Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.

FDAFeb 26, 2025Nationwide• Beckman Coulter Inc.

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