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EVIS EXERA III Duodenovideoscope (Olympus) – infection risk (2023)

Recent reports of patient infection.

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

Guider Softip Guide Catheter 8F (Boston Scientific) – tip curve issue (2023)

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Moderate

FDAJul 27, 2023Nationwide• Boston Scientific Corporation

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EVIS EXERA III Duodenovideoscope (Olympus) – infection risk (2023)

Guider Softip Guide Catheter 8F (Boston Scientific) – tip curve issue (2023)

Reusable Distal Attachments (Aomori Olympus) – DEHP risk (2023)

PASCAL Transcatheter Valve System (Edwards) – repair resistance (2023)

Olympus Distal Attachment (Aomori Olympus) – DEHP risk (2023)

Guider Softip Guide Catheter 6F (Boston Scientific) – tip curve issue (2023)

Guider Softip Guide Catheter 5F (Boston Scientific) – tip curve issue (2023)

Airway Mobilescope (Olympus) – endoscope lodging risk (2023)

Badam Pista Sandwich (BAPS Shayona) – undeclared colors (2023)

Anjir Roll (BAPS Shayona) – undeclared color additive (2023)

Plain Penda (BAPS Shayona) – undeclared soy (2023)

Mohanthal Fudge (BAPS Shayona) – undeclared ingredients (2023)

Bundi Ladoo (BAPS Shayona) – Undeclared Colors (2023)

Tobramycin Ophthalmic Solution (Alembic) – Impurity Specifications (2023)

Guider Softip Guide Catheter 7F (Boston Scientific) – tip curve issue (2023)

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

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

Bronchovideoscope (Olympus) – endoscope lodging risk (2023)

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

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