Klinika Mdical Gmb Achtzehnmorgenweg 6 Usingen Germany Recalls

FDAApr 4, 2025Nationwide• Klinika Mdical Gmb Achtzehnmorgenweg 6 Usingen Germany

SOLTIVE Pro SuperPul Laser Instrument (Olympus) – Treatment Parameter Deviation (2025)

Preset treatment parameters are not consistently being used in accordance with the IFU.

Moderate

FDAApr 4, 2025Nationwide• Olympus Corporation of the Americas

INSPIRA AIR Balloon Dilation System (Integra LifeSciences) – Incorrect Product Packaging (2025)

Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.

FDAApr 4, 2025

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Nationwide

• Integra LifeSciences Corp. (NeuroSciences)

Moroccan Lentil Soup (Request Foods) – wood contamination (2025)

Potential contamination with foreign material (wood)

Cuban-Style Black Bean Soup (Request Foods) – wood contamination (2025)

Potential contamination with foreign material (wood)

FDAApr 4, 2025Nationwide• Supplement Manufacturing Partner Inc.

Spermidine Supplement (Supplement Manufacturing) – undeclared wheat (2025)

Undeclared Allergen

Undeclared allergen: Wheat

Class IHigh

Blueberry Lemon Scones (Hot Chocolatier) – undeclared soy (2025)

Undeclared Allergen

Undeclared allergen (soy)

FDAApr 4, 2025IN, TN• The Hot Chocolatier - St. Elmo, LLC

Mexican Street Corn Soup (Request Foods) – wood contamination (2025)

Potential contamination with foreign material (wood)

Beecher's Street Corn (Request Foods) – wood contamination (2025)

Potential contamination with foreign material (wood)

CPSCApr 3, 2025Nationwide• Amesbury Industries Inc., d/b/a AmesburyTruth, of Houston, Texas

Casement Window Hinge Tracks (AmesburyTruth) – Impact Injury (2025)

This recall involves Ashland 10-inch and 14-inch two-bar right-hand and left-hand casement window hinge tracks installed in windows to allow the windows to be cranked opened and closed. The casement window hinge tracks include part numbers 2003558, 2003559, 2004271 and 2004272. These products can be identified by locating "R10," "L10," "R14" or "L14" located on the face of the casement window hinge track. These hinge tracks were manufactured and sold to residential and commercial window manufacturers in boxes dated April 2024 through December 2024.

High

Distal Femoral Augment (Waldemar Link) – Missing Thread Screw (2025)

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

FDAApr 3, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Tibial Augment (Waldemar Link) – Missing Thread Screw (2025)

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

FDAApr 3, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Enhanced Verify Handset (Medtronic) – Communication Malfunction (2025)

Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.

Moderate

FDAApr 3, 2025Nationwide• Medtronic Neuromodulation

L-Shaped Femoral Augment (Waldemar Link) – Missing Thread Screw (2025)

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

FDAApr 3, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Posterior Femoral Augment (Waldemar Link) – Missing Thread Screw (2025)

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

FDAApr 3, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

HistoCore PELORIS 3 (Leica Biosystems) – Tubing Leakage Issue (2025)

There is a leakage issue associated with the tubing in the manifold of the instrument.

FDAApr 2, 2025AZ, CA, FL +11 more• Leica Biosystems Melbourne Pty Ltd

Entegra Anthem (Entegra) – Diesel Fuel System Issue (2025)

Fire/Burn Risk

Jayco, Inc. (Jayco) is recalling certain 2024-2025 Entegra Anthem, Aspire, and 2025 Reatta XL motorhomes, equipped with Cummins L9 diesel engines. The remote fuel filter hose may separate from the fitting, causing a fuel leak and an engine stall.

High

NHTSAApr 2, 2025Nationwide• ENTEGRA

Aquadis 56 Washer Disinfector (Getinge) – Circulation Pump Timing Error (2025)

The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.

FDAApr 2, 2025Nationwide• Getinge Disinfection Ab Ljungadalsgatan

Haloperidol Decanoate Injection (Amerisource) – Sterility Risk (2025)

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

FDAApr 2, 2025Nationwide• Amerisource Health Services LLC

Haloperidol Decanoate Injection (Amerisource) – Sterility Risk (2025)

Lack of assurance of sterility. Bacterial contamination detected in some media fill units