Gracie&#x27;s Kitchens Inc. Recalls

Product may be contaminated with Listeria monocytogenes.

Fajita Mix (King Kullen) – Listeria Contamination (2024)

Product may be contaminated with Listeria monocytogenes.

Squash Noodles (Wild by Nature) – Listeria risk (2024)

FDANov 27, 2024IN, PA• Trokamed GmbH Kleine Breite 17 Geisingen Germany

Product may be contaminated with Listeria monocytogenes.

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Class II

Moderate

FDANov 27, 2024CT, NY• Gracie's Kitchens Inc.

Surgical Sheath 18 Fr (Trokamed) – Inflow Speed Risk (2024)

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

High

Stuffed Artichokes (King Kullen) – Listeria Risk (2024)

Product may be contaminated with Listeria monocytogenes.

Diced White Onion (King Kullen) – Listeria risk (2024)

Product may be contaminated with Listeria monocytogenes.

Watermelon Slices (King Kullen) – Listeria Contamination (2024)

Product may be contaminated with Listeria monocytogenes.

Sliced Mixed Peppers (Wild by Nature) – Listeria risk (2024)

Product may be contaminated with Listeria monocytogenes.

Watermelon Halo (King Kullen) – Listeria Risk (2024)

Product may be contaminated with Listeria monocytogenes.

Broccoli & Cauliflower Florets (Gracie's Kitchen) – Listeria risk (2024)

Product may be contaminated with Listeria monocytogenes.

Broccoli Florets (Gracie's Kitchens) – Listeria Contamination (2024)

Product may be contaminated with Listeria monocytogenes.

FDANov 26, 2024Nationwide• 3M Unitek Corporation

Transbond Plus Primer (3M Unitek) – Bracket Bond Failure (2024)

Due to an increase of complaints for bracket bond failures and skin irritation or blistering.

High

Access Intact PTH Assay (Beckman Coulter) – Reagent Dispense Issue (2024)

Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination, instrument errors, delays, or inaccurate results with a negative bias and increase in imprecision. The issue was confirmed on 10 April 2024 by Beckman Coulter through an internal non-conformance (NC-INT-66585). The well 0 scale on the filling line began malfunctioning on the fill immediately before PTH. The malfunction was not noticed until the majority of PTH was filled.

Moderate

FDANov 26, 2024Nationwide• Beckman Coulter, Inc.

Eclipse PRO Holter Recorder (Spacelabs) – Serial Number Error (2024)

Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.

FDANov 25, 2024AR, CA, CO +19 more• Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom

Eclipse Mini Holter Recorder (Spacelabs) – Serial Number Error (2024)

FDANov 25, 2024AR, CA, CO +19 more• Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom

Otological Ventilation Tube (Adept Medical) – Clearance Issue (2024)

Lack of 510(k) clearance.

FDANov 24, 2024Nationwide• Adept Medical Ltd 2-6 Mc Donald Street Morningside, Po Box 10075 Dominion Rd Auckland New Zealand

Biodesign Hiatal Hernia Graft (Cook) – IFU and Expiration (2024)

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

FDANov 22, 2024IN, MI• Cook Biotech, Inc.

Viking Travel Trailer (Viking) – Water Tank Support (2024)

Forest River, Inc. (Forest River) is recalling certain 2024-2025 Viking and Clipper travel trailers. The fresh water holding tank support bracket may be the incorrect gauge and may break.

High

NHTSANov 22, 2024Nationwide• VIKING TRAVEL TRAILERS

Biodesign Dural Graft (Cook) – IFU and Expiration (2024)

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

FDANov 22, 2024IN, MI• Cook Biotech, Inc.

Biodesign Otologic Butterfly Graft (Cook) – IFU and Expiration (2024)

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.