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Showing 3121–3140 of 68218 results

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Dinstuhl's Pecan Brittle (Dinstuhl's) – undeclared milk (2025)

Undeclared Allergen

Undeclared allergen (milk)

Class IIModerate

FDAMar 4, 2025IN, MS, MO• Dinstuhl's Fine Candy Company, Inc.

BaiWei ShanZhuang Plum Candy (Tristar Food) – contains cyclamates (2025)

Product contains cyclamates

FDAMar 4, 2025CO, FL, IL +8 more• Tristar Food Wholesale Co Inc

Latitude EV Humeral Revision Stem (Stryker) – Incorrect Part Marking (2025)

A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)

Moderate

FDAMar 3, 2025Nationwide• Tornier, Inc

NovumIQ Syringe Infusion System (Baxter) – Incorrect Installation (2025)

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.

FDAMar 3, 2025Nationwide• Baxter Healthcare Corporation

Comprehensive Shoulder Stem (Zimmer) – Surgical Insertion Problem (2025)

Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.

FDAMar 3, 2025Nationwide• ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY Deerpark Industrial Estate Oranmore Ireland

Medline Kits (Medline) – Packaging Seal Weakness (2025)

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

FDAMar 3, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

CDI OneView Monitoring System (Terumo) – Display Value Issue (2025)

During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.

FDAMar 3, 2025FL, IL, MI +3 more• Terumo Cardiovascular Systems Corporation

Dried Lily Flowers (U.S. Tov) – undeclared sulfites (2025)

Undeclared Allergen

Undeclared sulfites

FDAMar 3, 2025AL, AK, AR +27 more• U.S. Tov, Inc. dba U.S. Trading Company

Medline Convenience Kits (Medline) – Packaging Seal Weakness (2025)

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

FDAMar 3, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

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.

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

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

Domna's Baklava Tray (Optima Foods) – undeclared milk (2025)

Undeclared Milk

Contains undeclared milk

Class IIModerate

FDAFeb 28, 2025NY• Optima Foods, Inc.

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.

Little Leaf Southwest Salad Kit (Little Leaf) – incorrect dressing (2025)

Undeclared Allergen

Product may contain incorrect salad dressing, resulting in fish and wheat being undeclared.

FDAFeb 28, 2025CT, MA, NH• LITTLE LEAF FARMS LLC

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

Duloxetine Capsules 60mg (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 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

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

Chemical Contamination: Presence of benzene

Class IIModerate

FDAFeb 28, 2025Nationwide• Sigan Industries Group Inc.

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