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Showing 3141–3160 of 68218 results

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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

Duloxetine Capsules 30mg (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 6.25mg (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

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

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.

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.

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.

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.

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.

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.

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.

Coyote Valley Sour Cream & Onion Chips (Uncle Rays) – high sodium (2025)

Product contains higher sodium amount than stated on label

Class IIModerate

FDAFeb 27, 2025IN, NV, OH +1 more• Uncle Rays, LLC

Da Vinci 5 (Intuitive Surgical) – Foot Tray Pedal Failure (2025)

Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

FDAFeb 26, 2025Nationwide• Intuitive Surgical, Inc.

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.

Shiley Adult Tracheostomy Tube (Covidien) – Flange Disconnect Risk (2025)

Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.

FDAFeb 26, 2025Nationwide• Covidien

Blue Hawaiian Beverage Concentrate (Paletas) – undeclared color (2025)

Undeclared Allergen

Undeclared Red #3

FDAFeb 26, 2025AZ, NM, TX +1 more• Paletas Ice Cream, LLC

TS7500 MOBIUS Operating Table (Baxter) – Software Control Fault (2025)

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

FDAFeb 25, 2025Nationwide• Baxter Healthcare Corporation

Nasopore Nasal Dressing (Stryker) – Packaging Seal Issue (2025)

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

FDAFeb 25, 2025Nationwide• Stryker Corporation

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