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Showing 10121–10140 of 35905 results

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Tracheal Intubation Fiberscope (Olympus) – endoscope lodging risk (2023)

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

Henke-Ject-2 Syringes (Wolf) – sterile barrier damage (2023)

Sterile barrier might be damaged compromising the sterility of the device.

FDAJul 27, 2023Nationwide• Wolf, Henke Sass, Gmbh Kronenstrasse 16 Tuttlingen Germany

Bronchovideoscope (Olympus) – endoscope lodging risk (2023)

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

Moderate

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

Sky Wheels (Soft Play) – Fall Hazard (2023)

This recall involves Sky Wheels, which are an individual active play component manufactured for and sold to businesses. They can be incorporated into a larger indoor soft-contained play system. The Sky Wheel is comprised of a 14-inch diameter 4-spoke metal wheel attached to a downward facing milled and threaded shaft which is supported from an overhead bar within the play system framing structure.

CPSCJul 27, 2023Nationwide• Soft Play LLC, of Huntersville, North Carolina

Motichur Ladoo (BAPS Shayona) – undeclared colors (2023)

Undeclared Allergen

During an FDA inspection the firm was notified that some of their products contains undeclared Yellow #5 & #6.

Class IIModerate

FDAJul 27, 2023AL, FL, GA +3 more• BAPS Shayona

Kopra Paak Coconut Fudge (BAPS Shayona) – undeclared soy (2023)

During an FDA inspection the firm was notified that some of their products contains undeclared soy.

Class IIModerate

FDAJul 27, 2023AL, FL, GA +3 more• BAPS Shayona

Kaju Katri (BAPS Shayona) – Undeclared Color (2023)

Undeclared Allergen

During an FDA inspection the firm was notified that some of their products contains undeclared Yellow #5.

Class IIModerate

FDAJul 27, 2023AL, FL, GA +3 more• BAPS Shayona

Sangam Katri Rose Fudge (BAPS Shayona) – undeclared soy (2023)

During an FDA inspection the firm was notified that some of their products contains undeclared soy.

Class IIModerate

FDAJul 27, 2023AL, FL, GA +3 more• BAPS Shayona

Kesar Penda (BAPS Shayona) – undeclared ingredients (2023)

During an FDA inspection the firm was notified that some of their products contains undeclared soy and Yellow #5 & #6.

Class IIModerate

FDAJul 27, 2023AL, FL, GA +3 more• BAPS Shayona

Surti Ghari (BAPS Shayona) – undeclared ingredients (2023)

During an FDA inspection the firm was notified that some of their products contains undeclared soy and Yellow #6.

Class IIModerate

FDAJul 27, 2023AL, FL, GA +3 more• BAPS Shayona

Kaju Pista Roll (BAPS Shayona) – undeclared colors (2023)

Undeclared Allergen

During an FDA inspection the firm was notified that some of their products contains undeclared Yellow #5 & #6 and Blue 1.

Class IIModerate

FDAJul 27, 2023AL, FL, GA +3 more• BAPS Shayona

Burfi (BAPS Shayona) – undeclared soy (2023)

During an FDA inspection the firm was notified that some of their products contains undeclared soy.

Class IIModerate

FDAJul 27, 2023AL, FL, GA +3 more• BAPS Shayona

Hamilton-C1 Ventilator (Hamilton) – control board leak (2023)

Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

FDAJul 26, 2023Nationwide• Hamilton Medical, Inc.

Hamilton-T1 Ventilator (Hamilton) – control board leak (2023)

Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

FDAJul 26, 2023Nationwide• Hamilton Medical, Inc.

Hamilton-T1 ESM Shielding Set (Hamilton) – control board leak (2023)

Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

FDAJul 26, 2023Nationwide• Hamilton Medical, Inc.

OptiStem Rasp Handle (Waldemar Link) – weld crack risk (2023)

A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery

FDAJul 26, 2023GA, IN, TX• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Hamilton Control Board (Hamilton) – control board leak (2023)

Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

FDAJul 26, 2023Nationwide• Hamilton Medical, Inc.

TigerTough Seat Covers (TIGERTOUGH) – stitching problem (2023)

Sewn Products DBA TigerTough (TigerTough) is recalling certain TigerTough seat covers, models T62213BLK and T62131BLK. The stitching on the seat cover side flap may not break away as intended, causing the side air bag to incorrectly deploy in the event of a crash.

NHTSAJul 26, 2023Nationwide• TIGERTOUGH SEAT COVERS

ZX400 (KAWASAKI) – alternator connection issue (2023)

Kawasaki Motors Corp., U.S.A. (KMC) is recalling certain 2023 ZX400SPFNL motorcycles. The alternator may fail due to a loose connection between the rotor and crank shaft, causing an engine stall.

NHTSAJul 26, 2023Nationwide• KAWASAKI

Hamilton-T1 Ventilator (Hamilton) – control board leak (2023)

Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

FDAJul 26, 2023Nationwide• Hamilton Medical, Inc.

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