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Showing 7181–7200 of 8389 results

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Cardinal Health: SmartGown Breathable Surgical Gowns with raglan sleeves X...

Potential for open packaging seals compromising the sterility of the surgical gowns

FDANov 2, 2021Nationwide• Cardinal Health

Cardinal Health: Cardinal Health Poly-Reinforced Surgical Gowns Large SKU:...

Potential for open packaging seals compromising the sterility of the surgical gowns

FDANov 2, 2021Nationwide• Cardinal Health

Cardinal Health: SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Go...

Potential for open packaging seals compromising the sterility of the surgical gowns

FDANov 2, 2021Nationwide• Cardinal Health

Olympus Corporation of the Americas: EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model...

Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.

FDANov 2, 2021Nationwide• Olympus Corporation of the Americas

Cardinal Health: RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518

Potential for open packaging seals compromising the sterility of the surgical gowns

FDANov 2, 2021Nationwide• Cardinal Health

Smith & Nephew, Inc.: smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, ...

Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.

FDANov 1, 2021Nationwide• Smith & Nephew, Inc.

Human Care USA, Inc.: Hanger-Bar 2P 45cm

The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). As a result of the set screw loosening, there is the potential for a fall hazard.

FDANov 1, 2021Nationwide• Human Care USA, Inc.

Smith & Nephew, Inc.: smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM,...

Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.

FDANov 1, 2021Nationwide• Smith & Nephew, Inc.

Philips North America Llc: Wireless Footswtich used with the following Philips Allur...

Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure

FDAOct 29, 2021Nationwide• Philips North America Llc

NuVasive Specialized Orthopedics, Inc.: NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) a...

The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

FDAOct 29, 2021AL, AK, AZ +44 more• NuVasive Specialized Orthopedics, Inc.

Palodex Group Oy Nahkelantie 160 Tuusula Finland: Orthopantomograph OP300 dental computed tomography x-ray ...

It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not within the set acceptance criteria (repeatability within 4%).

FDAOct 28, 2021Nationwide• Palodex Group Oy Nahkelantie 160 Tuusula Finland

Osteomed, LLC: OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower ...

Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.

FDAOct 28, 2021Nationwide• Osteomed, LLC

MAX LUX CORP 03e 01 01 Yangxi Indust Ry Zone Yangjiangyangjiang China: The product is a handheld ultraviolet-C germicidal wand a...

Excessive ultraviolet-C radiation

FDAOct 26, 2021Nationwide• MAX LUX CORP 03e 01 01 Yangxi Indust Ry Zone Yangjiangyangjiang China

Northgate Technologies, Inc.: Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic...

The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.

FDAOct 25, 2021MA• Northgate Technologies, Inc.

Smith & Nephew, Inc.: Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1...

The labels on the packages of screws were switched.

FDAOct 25, 2021AL, AZ, CA +22 more• Smith & Nephew, Inc.

Atrium Medical Corporation: The Ocean Water Seal Chest Drain is a plastic, three bott...

Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient

FDAOct 22, 2021Nationwide• Atrium Medical Corporation

Thoratec Corp.: Abbott HeartMate Touch Communication System, REF: HMT1100...

If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the Bluetooth connectivity interference may cause the system App to close or fail to open. Once Bluetooth adaptor is connected, barring disconnection, all functionality is unaffected; the device will continue to operate as expected.

FDAOct 22, 2021Nationwide• Thoratec Corp.

Boston Scientific Corporation: HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dila...

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

FDAOct 21, 2021Nationwide• Boston Scientific Corporation

AMO Manufacturing USA, LLC: iDesign, Model - G300: System AWS (International), System...

Laceration Risk

Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights.

FDAOct 21, 2021AL, AK, AZ +44 more• AMO Manufacturing USA, LLC

Philips North America Llc: CombiDiagnost R90 1.0 and 1.1 multi-functional general R/...

If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.

FDAOct 21, 2021Nationwide• Philips North America Llc

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