Product label does not list ingredients including major food allergens: wheat and soy (vegetable oil). Additional undeclared ingredients include: niacin, reduced iron, vitamin B1, vitamin B2, invert sugar

Class IIModerate

FDAAug 12, 2025CA, CT, GA +14 more• Bakers Authority LLC

Assorted Cheese Flight (Wegmans) – Listeria contamination (2025)

Listeria

Products may be contaminated with Listeria monocytogenes

Class IHigh

FDAAug 12, 2025CT, DE, MD +7 more• Wegmans Food Markets, Inc.

FLEX Monoclonal Mouse Antibody (Agilent) – weak staining (2025)

Their is the potential for weak staining which may result in false negative CD20 identification.

Moderate

FDAAug 11, 2025Nationwide• Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark

Atellica CH Protein Test (Siemens) – false result risk (2025)

Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.

Low

FDAAug 11, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Lisdexamfetamine Capsules (Lannett) - Label Mix-up (2025)

Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.

Class IIModerate

FDAAug 11, 2025Nationwide• Lannett Company Inc.

Merge Hemo Software (Merge Healthcare) – patient data issue (2025)

Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client (Pressure Sensor Defective) during non-invasive blood pressure (NIBP) measurements, specifically when the initial inflation pressure is set in the high-pressure range (>240 mmHg). The ARGUS PB-3000 is a vital signs monitoring instrument intended to be integrated into the Merge Hemo System. No other components of the Merge Hemo System are affected.

Moderate

FDAAug 11, 2025Nationwide• Merge Healthcare, Inc.

Brie Royal Faucon (Fromi Usa) – Listeria contamination (2025)

Listeria

Product may be contaminated with Listeria monocytogenes

Class IHigh

FDAAug 11, 2025NY• Fromi Usa

Biscuit Mix (Griffith Foods) – Undeclared eggs (2025)

Undeclared Egg

Undeclared eggs

Class IIModerate

FDAAug 10, 2025IN, LA, NC• Griffith Foods Inc.

VACUETTE Coagulation Tube (Greiner) – label misplacement (2025)

Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.

Low

FDAAug 8, 2025Nationwide• Greiner Bio-One North America, Inc.

Sterile Medline Convenience Kits (Unknown) – sterilization failure (2025)

Convenience kits labeled as sterile have not gone through the sterilization process.

High

FDAAug 8, 2025FL, MD, NJ +1 more

RayStation Software (RaySearch) – UID uniqueness (2025)

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

Low

FDAAug 8, 2025Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

Argus PB-3000 Monitor (Schiller) – measurement error (2025)

Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.

Moderate

FDAAug 8, 2025Nationwide• Schiller, Ag Altgasse 68 Baar Switzerland

UDK Half Plum (Sungal) – Cyclamate adulteration (2025)

Cyclamate adulteration

Class IIILow

FDAAug 8, 2025CA, MD, NY +1 more• SUNGAL INC

Continu-Flo Solution Set (Baxter) – customer reports (2025)

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.

High

FDAAug 8, 2025Nationwide• Baxter Healthcare Corporation

IntelliSpace Cardiovascular (Philips) – outdated info (2025)

Software issue that results in the display of outdated information.

Low

FDAAug 8, 2025Nationwide• Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands

Duloxetine Capsules (Breckenridge) - CGMP Impurity (2025)

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

Class IIModerate

FDAAug 8, 2025AZ, IN, NJ• Breckenridge Pharmaceutical, Inc.

Theophylline Tablets (Glenmark) - Failed Dissolution (2025)

Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.

Class IIModerate

FDAAug 8, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

FloPatch FP120 (Flosonics) – expiry date error (2025)

Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.

Low

FDAAug 7, 2025Nationwide• Flosonics Medical (R/A 1929803 ONTARIO CORP.) Fourth Floor, Oneeleven 325 Front St W Toronto Canada

1...63 646566 67...3411

Page 65 of 3411Next