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Showing 8421–8440 of 35916 results

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OralProCare Lip Treatment (Den-Mat) – Specification Deviation (2024)

CGMP Deviations: products may not conform to the labeled specifications.

Class IIModerate

FDAJan 16, 2024Nationwide• Den-Mat Holdings, LLC

IV Start Kit (Medical Action) – Saline Syringe Recall (2024)

The kits contain saline flush syringes which were recalled by the supplier.

High

FDAJan 15, 2024Nationwide• Medical Action Industries, Inc.

Kenworth T180 (Kenworth) – Mirror Lock Issue (2024)

PACCAR Incorporated (PACCAR) is recalling certain 2022-2024 Peterbilt 535, 536, 537, 548, and Kenworth T180, T280, T380, T480 trucks. The glass lock ring on the cab mirror assembly may not be fully seated, allowing the mirror glass to detach.

Low

NHTSAJan 15, 2024Nationwide• KENWORTH

Directional Laser Probe (D.O.R.C.) – Fiber Extension Problem (2024)

When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.

Moderate

FDAJan 15, 2024Nationwide• D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands

3M Specialty Blade Assembly (3M) – Burn Risk (2024)

Fire/Burn Risk

3M has added the following cautionary statement regarding the use of the product: "Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41C (105.8F). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60C (140F) and the Model 9660 blade maximum temperature may reach 77C (170.6F)."

Low

FDAJan 12, 2024Nationwide• 3M Company Health Care Business 3m Center

E-One Cyclone II (E-One) – Steering Assist Bracket Issue (2024)

E-One Incorporated (E-One) is recalling certain 2022-2023 Cyclone 2, Cyclone N, Typhoon N, and 2023 Cyclone E vehicles. The steering assist bracket may have been machined incorrectly.

High

NHTSAJan 12, 2024Nationwide• E-ONE

Vasopressin Sodium Chloride (IntegraDose) – Subpotent Drug (2024)

Subpotent Drug

Class IIModerate

FDAJan 12, 2024MN• IntegraDose Compounding Services LLC

Neptune's Fix Tianeptine Elixir (Neptune Resources) – Unapproved Drug (2024)

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

Class IHigh

FDAJan 12, 2024Nationwide• Neptune Resources, LLC

Neptune's Fix Tianeptine Elixir (Neptune Resources) – Unapproved Drug (2024)

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

Class IHigh

FDAJan 12, 2024Nationwide• Neptune Resources, LLC

Neptune's Fix Tianeptine Tablets (Neptune Resources) – Unapproved Drug (2024)

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

Class IHigh

FDAJan 12, 2024Nationwide• Neptune Resources, LLC

Colonoscope PCF-H180AL (Olympus) – Adhesive Deficiency (2024)

Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

Moderate

FDAJan 11, 2024Nationwide• Olympus Corporation of the Americas

Apollo Onyx Delivery Microcatheter (Micro Therapeutics) – Indications Mismatch (2024)

European version of microcatheter were distributed within US which contain a different "Indications for Use".

Low

FDAJan 11, 2024Nationwide• Micro Therapeutics, Inc.

Command Light Towers (Command Light) – Wiring Issue (2024)

Fire/Burn Risk

SVI Trucks is recalling certain Command Light Towers & Traffic Flowboards that contain Weldon 8X16 Input-Output nodes. In the event of a short circuit or wiring failure, the firmware in the node may fail to shut off the output pin, resulting in overloaded electrical circuits.

High

NHTSAJan 11, 2024Nationwide• COMMAND LIGHT

Brasseler Dental Bur (Brasseler) – Grip Detail Defect (2024)

The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.

Low

FDAJan 11, 2024Nationwide• Brasseler USA I Lp

Justin Boots Keaven Work Boots – Crush Hazard (2024)

This recall involves the Men's Dark Brown Keaven WP Met Guard Work Boots with model SE4570 manufactured in July and August 2022. The recalled leather work boots are slip-on and look like cowboy boots. They have a metatarsal guard and a steel toe to protect the wearer's feet. The boots are tan and brown with decorative stitching on the uppers. The boots were sold in men's sizes 7 through 14. The boots have a red color label on the outsole that reads "Justin". "Justin" is also stamped into the leather near the outside heel of the product. The labels "Steel Toe" and "Met Guard" are sewn into the seam on the side of the products. A label heat transferred onto the inside of the top of the shaft of the boot includes the manufacturing date code of either 07/22 NH or 08/22 NH representing the month and year.

Moderate

CPSCJan 11, 2024Nationwide

Altec Aerial Device (Altec) – Electrical Cable Problem (2024)

Fire/Burn Risk

Altec Industries, Inc. (Altec) is recalling certain 2004-2023 AT Series aerial devices. The cables in the engine compartment may contact the vehicle's hood, damaging the cables and causing a short circuit.

High

NHTSAJan 11, 2024Nationwide• ALTEC

Colonoscope CF-Q180AL (Olympus) – Adhesive Deficiency (2024)

Moderate

FDAJan 11, 2024Nationwide• Olympus Corporation of the Americas

Colonoscope PCF-Q180AL (Olympus) – Adhesive Deficiency (2024)

Moderate

FDAJan 11, 2024Nationwide• Olympus Corporation of the Americas

BrightDrop EV600 (BrightDrop) – Oil Leak Risk (2024)

Fire/Burn Risk

General Motors, LLC (GM) is recalling certain 2022 BrightDrop EV600 vehicles. The front-drive unit may leak oil and cause an engine compartment fire.

High

NHTSAJan 11, 2024Nationwide• BRIGHTDROP

Furniture Tip Restraints (New Age) – Safety Risk (2024)

This recall involves plastic New Age furniture tip restraint kits that were sold and distributed by various furniture companies with clothing storage units. Participating Furniture Companies American Drew American Woodcrafters Amini Innovation Corporation Ashley Furniture Industries, LLC Aspenhome Austin Group Furniture, LLC Avalon International Inc., LLC Bassett Furniture Industries, Inc. Drew and Jonathan by Hooker Furnishings Emery Park FD Home Corp. Flexsteel Industries, Inc. Furniture Values International, LLC Homelegance USA, LLC Hooker Furnishings Kincaid Furniture LC Direct Furniture Legacy Classic/Modern Furniture Liberty Furniture Industries, Inc. Magnussen Home Furnishings, Inc. New Classic Home Furnishings, Inc. Parker House Furniture Progressive Furniture Pulaski Furniture Riverside Furniture Samuel Lawrence Springhill Designs Standard Furniture Manufacturing Co., LLC Universal Furniture Van Thiel & Co. Vanguard Furniture Company. The New Age tip restraint kits included a plastic zip-tie, two brackets, and two screws and were sold with clothing storage units manufactured in Vietnam. The date of manufacture should be listed on a sticker or stamped on the clothing storage unit as November 2019 or later. The packaging of the recalled tip kits is white with black lettering and includes directions on how to anchor furniture. The bottom of the packaging states "Manufactured by New Age Industries."

High

CPSCJan 11, 2024Nationwide• New Age Industries Co. LTD, of Vietnam

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