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Custom Tubing Kit (Merit Medical) – Air Trapping Risk (2025)

High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

Moderate

FDAJun 5, 2025Nationwide• Merit Medical Systems, Inc.

Crispy Shrimp Roll 10Pc (Hy-Vee) – Listeria Contamination (2025)

Listeria

Potential contamination with Listeria monocytogenes

Class IHigh

FDAJun 5, 2025Nationwide• Hy-Vee

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Custom Tubing Kit (Merit Medical) – Air Trapping Risk (2025)

Crispy Shrimp Roll 10Pc (Hy-Vee) – Listeria Contamination (2025)

Duo Spicy Veg Shrimp 10Pc (Hy-Vee) – Listeria Contamination (2025)

Spicy Shrimp Poke Bowl (Hy-Vee) - Listeria Risk (2025)

Crunchy Shrimp Roll (Hy-Vee) – Listeria Contamination (2025)

ADVIA Calibrator (Siemens Healthcare) – Platelet Value Error (2025)

T4 Total ELISA (DRG International) – Expiration Date Mismatch (2025)

Azurion 7 M20 X-Ray (Philips Medical) – Gearbox Bolt Loosening (2025)

UROSKOP Omnia (Siemens Medical) – Frequency Inverter Fire Risk (2025)

ADVIA 3-in-1 Control (Siemens Healthcare) – Platelet Value Error (2025)

Zvu Anorectal Manometry Kit (Diversatek) – Expiration Date Mislabel (2025)

UROSKOP Omnia Max (Siemens Medical) – Frequency Inverter Fire Risk (2025)

Bornstein Frozen Shrimp Meat (Bornstein) – Listeria Contamination (2025)

SwabCap Disinfecting Cap (ICU Medical) – Seal Integrity Issue (2025)

BD Heyman Follower Straight Tip (C.R. Bard) – Catheter Size Incorrect (2025)

Bard Urologist's Tray (C.R. Bard) – Catheter Size Incorrect (2025)

BD FACS Setup Beads (Becton Dickinson) – Spectral Overlap Error (2025)

Hamilton C6 (Hamilton Medical) – Circuit Board Mechanical Defect (2025)

Bravo CF Capsule Device (Given Imaging) – Adhesive Malfunction (2025)

BD FACS Setup Beads (Becton Dickinson) – Spectral Overlap Error (2025)