Cut Fruit Express, Inc. Recalls

Cantaloupe containing products may be contaminated with Salmonella.

Cut Cantaloupe (Cut Fruit Express) – Salmonella Risk (2023)

Cantaloupe containing products may be contaminated with Salmonella.

Mixed Fruit (Cut Fruit Express) – Salmonella in Cantaloupe (2023)

Cantaloupe containing products may be contaminated with Salmonella.

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Class IHigh

FDANov 24, 2023IL, MN, WI• Cut Fruit Express, Inc.

Mixed Fruit (Cut Fruit Express) – Salmonella in Cantaloupe (2023)

Cantaloupe containing products may be contaminated with Salmonella.

Mixed Fruit (Cut Fruit Express) – Salmonella in Cantaloupe (2023)

Cantaloupe containing products may be contaminated with Salmonella.

Mixed Fruit (Cut Fruit Express) – Salmonella in Cantaloupe (2023)

Cantaloupe containing products may be contaminated with Salmonella.

Mixed Fruit Products (Cut Fruit Express) – Salmonella Contamination (2023)

Cantaloupe containing products may be contaminated with Salmonella.

Actim PROM Dipstick – Lubricant Interference (2023)

Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result.

FDANov 23, 2023Nationwide• ACTIM OY Klovinpellontie 3 Espoo Finland

Fujifilm Mobile X-Ray System – Incorrect Default Settings (2023)

When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.

FDANov 23, 2023Nationwide• FUJIFILM Healthcare Americas Corporation

DeRoyal Cardiac Cath Kit – Recalled Transducer (2023)

Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.

FDANov 22, 2023VA• DeRoyal Industries Inc

Threshold Warning Kit – Wheelchair Lift Issue (2023)

Ricon Corporation (Ricon) is recalling certain Threshold Warning System Kits (TWS) with part number RI32885, designed for use with Ricon Baylift and Mirage Series wheelchair lifts. The red beacon lighting on the TWS may not be bright enough. As such, these kits fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 403, "Platform Lift Systems."

NHTSANov 22, 2023Nationwide• THRESHOLD WARNING KIT

SANDIMMUNE Oral Solution (Novartis) – Crystallization Risk (2023)

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals

FDANov 22, 2023Nationwide• Novartis Pharmaceuticals Corporation

buPROPion Tablets (Sun Pharmaceutical) – Failed Dissolution (2023)

Failed Dissolution Specifications

Class IIILow

FDANov 22, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

TING Athlete's Foot Spray (Insight Pharmaceuticals) – Benzene Contamination (2023)

Chemical Contamination; presence of benzene.

FDANov 22, 2023Nationwide• Insight Pharmaceuticals Corporation

Exactech Equinoxe Reverse Shoulder System – Vacuum Bag Loss (2023)

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

Exactech Novation Hip System – Vacuum Bag Loss (2023)

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

Exactech Optetrak Logic Knee System – Vacuum Bag Loss (2023)

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

Exactech Vantage Ankle System – Vacuum Bag Loss (2023)

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

FDANov 21, 2023Nationwide• Beckman Coulter, Inc.

DxI 9000 Access Immunoassay Analyzer – Performance Issues (2023)

There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2) System provides numerical results that are below the lowest reportable result if laboratory chooses to report assay results in units of measurement other than the defined default units; 3) A result of 0 incorrectly reported when the system utilizes an expression that utilizes non-numerical symbols (e.g., > or <) to derive a calculated test as part of result reporting; 4) Reserve volume is enabled and the assay LIS code is not the same as the assay Test ID. These issues could potentially lead to erroneous results or delay reporting results for multiple analytes.

Low

Exactech Alteon Hip XLE Liner – Vacuum Bag Loss (2023)

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.