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FlexLab System (Inpeco) – Sample Integrity Issue (2025)

The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.

FDASep 3, 2025CA, NY• Inpeco S.A. Via San Gottardo 10 Lugano Switzerland

Peanut Butter Crush Bar (Zingerman's) – Undeclared Cashew (2025)

Undeclared Allergen

Undeclared cashew

FDASep 3, 2025IN, MI, NY• Zingerman's Coffee Company

Ultra Whey Protein Powder (New Spirit) – Undeclared Milk (2025)

Undeclared Allergen

undeclared allergen ingredient Milk.

Class IIModerate

FDASep 3, 2025Nationwide• New Spirit Naturals Inc.

Artegraft Collagen Vascular Grafts (LeMaitre) – Raw Material Issue (2025)

The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.

FDASep 2, 2025Nationwide• LeMaitre Vascular, Inc.

Digital Radiography System (Canon Medical) – ROI Default Issue (2025)

It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used.

FDASep 2, 2025Nationwide• Canon Medical System, USA, INC.

Tribio Implant (Berkeley Advanced Biomaterials) – Incorrect Label (2025)

Due to incorrect product label (Incorrect product name identified on outer packaging).

FDASep 2, 2025Nationwide• Berkeley Advanced Biomaterials, LLC

Norgestimate and Ethinyl Estradiol (AvKARE) – Content uniformity issue (2025)

Failed Content Uniformity Specifications

Class IIModerate

FDASep 2, 2025Nationwide• AvKARE

Sulfamethoxazole and Trimethoprim (Major) – Foreign substance packaging (2025)

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDASep 2, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

NES 0.9mm RX Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

CLEARLINK CONTINU-FLO Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

NES Turbo Elite 0.9mm Catheter (Northeast Scientific) – Sterility Breach (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

NES Turbo Elite 1.4mm Catheter (Northeast Scientific) – Sterility Breach (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

ClariTEE TEE Probe (ImaCor) – Articulation Error (2025)

Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.

FDAAug 29, 2025Nationwide• ImaCor Inc.

NES 1.4mm Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

Optiflux Dialyzer (Fresenius) – Cap Configuration (2025)

To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.

FDAAug 29, 2025Nationwide• Fresenius Medical Care Holdings, Inc.

CONTINU-FLO Solution Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

CLEARLINK Paclitaxel Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

NES 1.7mm RX Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

NES Turbo Elite 2.0mm Catheter (Northeast Scientific) – Sterility Breach (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

CLEARLINK Extension Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

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