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Showing 4421–4440 of 68218 results

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Morphine Sulfate Tablets 15mg (Dr. Reddy's) – Impurity Spec Failure (2024)

Failed Impurities/Degradation Specification

Class IIModerate

FDAOct 22, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Kirkland Signature Smoked Salmon (Acme Smoked Fish) - Listeria Risk (2024)

The firm was notified after laboratory analysis that the product test positive for Listeria monocytogenes.

FDAOct 22, 2024FL, IN• Acme Smoked Fish Corp.

Ivalon Surgical Spear (Carwild) – Package Seal Issue (2024)

Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.

Moderate

FDAOct 22, 2024AL, FL, IL +2 more• Carwild Corporation

Repacked Yellow Onions (Taylor Farms) – E. Coli Risk (2024)

Potential contamination of E. coli O157:H7

FDAOct 22, 2024CO, IN, KS +4 more• Taylor Farms Colorado, Inc.

MICRO-X Rover Mobile X-ray System (Micro-X) – Operation Requirements (2024)

Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.

FDAOct 22, 2024CA, MD, TX +1 more• Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia

Imperial Fresh Produce (FreshPoint) – E. Coli Risk (2024)

Potentially contaminated with E. coli O157:H7.

FDAOct 22, 2024CO• FreshPoint Denver, Incorporated

Yellow Onions (Taylor Farms) – E. Coli Risk (2024)

Potential contamination of E. coli O157:H7

FDAOct 22, 2024CO, IN, KS +4 more• Taylor Farms Colorado, Inc.

Medline Iris Scissors (Medline) – Tip Protector Failure (2024)

Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.

FDAOct 21, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Karl Storz Irrigation Tubing (Karl Storz) – Labeling Error (2024)

Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.

FDAOct 21, 2024Nationwide• Karl Storz Endoscopy

JuggerLoc Drill Guide (Biomet) – Packaging Deformation (2024)

Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.

FDAOct 21, 2024Nationwide• Biomet, Inc.

Baxter MiniCap PD Transfer Set (Baxter) – Chemical Risk (2024)

Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

FDAOct 21, 2024Nationwide• Baxter Healthcare Corporation

Atwater's Spider Web Tarts (One Roof) - Undeclared Almonds (2024)

Undeclared Nuts

Undeclared tree nuts (almonds)

FDAOct 21, 2024MD, VA, DC• One Roof LLC

Siemens Atellica Cuvette Segment (Siemens) – Manufacturing Defect (2024)

A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate.

FDAOct 21, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica B2M Test (Siemens) – Result Accuracy Issue (2024)

Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH 2-Microglobulin (B2M) reagent.

FDAOct 21, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Chlorpheniramine Tablets (BLI) – Stability Assay Issue (2024)

Superpotent Drug: Stability failure for assay at 6 months test time-point.

Class IIModerate

FDAOct 21, 2024MO, OH• BLI International, Inc.

Z-800 Infusion System (Zyno Medical) – Battery Discharge (2024)

Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.

FDAOct 18, 2024Nationwide• Zyno Medical LLC

Biofill Infiltration Cannula (Human Med) – Water Jet Deviation (2024)

The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.

FDAOct 18, 2024Nationwide• HUMAN MED AG Wilhelm-Hennemann-Str. 9 Schwerin Germany

Essenz HLM (LivaNova) – Touchscreen Interruption (2024)

Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.

FDAOct 18, 2024Nationwide• LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany

Fresh Express Chicken Caesar Salad (Fresh Express) - Listeria Contamination (2024)

Potential Listeria Monocytogenes Contamination. The pre-packaged condiment trays contains chicken linked to the Bruce Pac recall.

FDAOct 18, 2024CA, IL, IN +9 more• Fresh Express Incorpated

Fresh Express Santa Fe Greek Salad (Fresh Express) - Listeria Contamination (2024)

Potential Listeria Monocytogenes Contamination. The pre-packaged condiment trays contains chicken linked to the Bruce Pac recall.

FDAOct 18, 2024CA, IL, IN +9 more• Fresh Express Incorpated

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