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Showing 1441–1460 of 11714 results

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TOPS Inserter (Premia Spine) – Missing Pin Risk (2025)

Potential for missing pins at tip of inserter.

FDAJul 16, 2025Nationwide• PREMIA SPINE LTD Giborey Israel 7 Ramat Poleg Netanya Israel

Sushi Wasabi (Ming Hong) – Undeclared Yellow 5 (2025)

Individual consumer size Wasabi mini pack label does not declare allergen ingredient Yellow 5.

Class IIModerate

FDAJul 16, 2025CA, CO, FL +17 more• MING HONG INTERNATIONAL INC.

Molly's Kitchens Tuna Salad (Reser's) – Listeria Risk (2025)

Listeria

Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.

Class IHigh

FDAJul 16, 2025AR, CO, FL +26 more• Reser's Fine Foods, Inc.

Tuna Salad (Reser's) – Listeria Contamination (2025)

Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.

FDAJul 16, 2025AR, CO, FL +26 more• Reser's Fine Foods, Inc.

Signature Cafe Tuna Salad (Reser's) – Listeria Risk (2025)

Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.

FDAJul 16, 2025AR, CO, FL +26 more• Reser's Fine Foods, Inc.

Sysco Classic Tuna Salad (Reser's) – Listeria Risk (2025)

Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.

FDAJul 16, 2025AR, CO, FL +26 more• Reser's Fine Foods, Inc.

Gourmet Tuna Salad (Reser's) – Listeria Contamination (2025)

Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.

FDAJul 16, 2025AR, CO, FL +26 more• Reser's Fine Foods, Inc.

Tuna Salad (Reser's) – Listeria Contamination (2025)

Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.

FDAJul 16, 2025AR, CO, FL +26 more• Reser's Fine Foods, Inc.

Sysco Imperial Deluxe Tuna Salad (Reser's) – Listeria Risk (2025)

Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.

FDAJul 16, 2025AR, CO, FL +26 more• Reser's Fine Foods, Inc.

Prosthesis Head B (Waldemar Link) – Labeling Inconsistency (2025)

Inconsistent size terminology and color coding used on labeling

FDAJul 15, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Chromophare Surgical Light (Stryker) – Coating Stress Lines (2025)

Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.

FDAJul 15, 2025Nationwide• Stryker Communications

Plastic Trial Head (Waldemar Link) – Labeling Inconsistency (2025)

Inconsistent size terminology and color coding used on labeling

FDAJul 15, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Duloxetine Capsules (Breckenridge Pharmaceutical) – Impurity Concern (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit

Class IIModerate

FDAJul 15, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Medline ReNewal Catheters (Medline) – Particulate Contamination (2025)

Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.

FDAJul 14, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Corin Operating Tables (Maquet) – Device Interference Risk (2025)

Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel.

FDAJul 14, 2025Nationwide• MAQUET GMBH Kehler Str. 31 Rastatt Germany

3mensio Workstation (PIE Medical) – Measurement Error (2025)

When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage

FDAJul 14, 2025Nationwide• PIE Medical Imaging B.V. Demertdwarsstraat 8A01 Maastricht Netherlands

Spectrum IQ Infusion Pump (Baxter) – Grease Breakdown (2025)

Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.

FDAJul 14, 2025AZ, FL• Baxter Healthcare Corporation

American Contract Systems Kits (ACS) – Sterilization Concern (2025)

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

FDAJul 14, 2025IL, LA• American Contract Systems Inc

Pistachio Cacao Cream (World Market) – Salmonella Risk (2025)

Salmonella. The firm was notified by the FDA that the product may be contaminated with Salmonella.

FDAJul 14, 2025AL, AZ, CA +29 more• World Market Management Services, LLC

Baxter Novum IQ Pump (Baxter) – Infusion Transition Risk (2025)

Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.

FDAJul 14, 2025Nationwide• Baxter Healthcare Corporation

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