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Showing 5341–5360 of 68218 results

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Potatoes Creamy Deluxe (Reser's) – temperature abuse (2024)

Product may become spoiled due to temperature abuse. The temperature abuse was the result of a malfunctioning refrigeration unit on trailer #184.

Class IIModerate

FDAJul 29, 2024CA, IL, IN +3 more• Reser's Fine Foods, Inc.

Ground Cinnamon (El Chilar) – high lead levels (2024)

Due to elevated levels of lead. Sample collected by Maryland Department Of Health (MDDH) tested positive for high levels of lead in ground cinnamon.

Class IIModerate

FDAJul 29, 2024IN, MD• EL Chilar-HF, LLC

Pan De Rancho (La Superior) – undeclared sesame (2024)

Undeclared Allergen

Undeclared Allergen - Sesame seeds

Class IIModerate

FDAJul 29, 2024AL• La Superior Bakery

Van Leeuwen Vegan Oat Dessert – undeclared peanuts (2024)

Undeclared Allergen

Undeclared peanuts (allergen)

FDAJul 29, 2024NY• Van Leeuwen Ice Cream LLC

CustomEyes Procedure Packs (Beaver Visitec) – Syringe Recall (2024)

Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.

FDAJul 26, 2024Nationwide• Beaver Visitec International, Inc.

Arrow Arterial Kits and Trays as follows: (1) Arrow Arte... (ARROW INTERNATIONAL Inc.) – reports have been received regarding ... (2024)

Reports have been received regarding open seals on the packaging.

FDAJul 26, 2024Nationwide• ARROW INTERNATIONAL Inc.

Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use i... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

BiomarC EX Fiducial Marker System, Catalog Number 040165 (Carbon Medical Technologies, Inc.) – this recall has been initiated due to... (2024)

This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.

FDAJul 26, 2024Nationwide• Carbon Medical Technologies, Inc.

ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use ... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Progesterone Injection (Eugia US LLC) – Glass Particle Risk (2024)

Presence of Particulate Matter: Complaint received of a glass particle in the vial.

Class IIModerate

FDAJul 26, 2024Nationwide• Eugia US LLC

CustomEyes Procedure Packs (Beaver Visitec) – Syringe Recall (2024)

Data in RES.

FDAJul 26, 2024Nationwide• Beaver Visitec International, Inc.

Atellica IM CA 19-9 (Siemens) – Test Result Bias (2024)

Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic ... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use i... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/... (Intrinsic Therapeutics, Inc.) – at least two units have been found to... (2024)

At least two units have been found to be missing a weld.

FDAJul 25, 2024Nationwide• Intrinsic Therapeutics, Inc.

Vivo 45 LS, pressure and volume ventilator capable of del... (Breas Medical, Inc.) – there is a potential for short term (... (2024)

There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.

FDAJul 25, 2024Nationwide• Breas Medical, Inc.

Cinnamon Powder (Alb-USA) – High Lead Levels (2024)

Product contains elevated levels of lead (3.294ppm)

Class IIModerate

FDAJul 25, 2024CT, MA, MI +1 more• Alb-USA Enterprises Inc

NEUROSIGN Disposable Stimulating Dissector, REF 5888-00 (Technomed Europe Amerikalaan 71 Maastricht-Airport Netherlands) – product has have presence of brown di... (2024)

Product has have presence of brown discoloration or substance on the hinge area of the device

FDAJul 25, 2024CA, FL, IL +4 more• Technomed Europe Amerikalaan 71 Maastricht-Airport Netherlands

Stryker iBur 3.0mm Diamond Match Head, Distal Bend - inte... (Stryker Corporation) – potential for the product to exhibit ... (2024)

Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.

FDAJul 24, 2024Nationwide• Stryker Corporation

Stryker TMJ Unilateral Implant, REF: GHG010, consisting ... (TMJ Solutions Inc) – patient-fitted temporomandibular (tmj... (2024)

Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO

FDAJul 24, 2024Nationwide• TMJ Solutions Inc

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