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Showing 3841–3860 of 4465 results

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ReNewal Coblator II ENT Evac Wand (Medline) – Drip Chamber Disconnection (2025)

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

FDAMar 5, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

HiResolution Bionic Ear Battery Charger (Advanced Bionics) – Incorrect Packaging (2025)

Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

FDAMar 5, 2025AZ, FL, MI +3 more• Advanced Bionics, LLC

ReNewal ENT Coblator II PROcise Wand (Medline) – Drip Chamber Disconnection (2025)

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

Moderate

FDAMar 5, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

HoloBlueprint Application (Stryker) – Guidance Instrumentation Difficulties (2025)

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

FDAMar 5, 2025AK, ID, MA +4 more• Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France

Mercedes-Benz Tourrider Premium (Mercedes-Benz) – Seat Fixation Problem (2025)

Daimler Coaches North America (Daimler Coaches) is recalling certain 2022-2025 Mercedes Benz Tourrider Business and Premium transits buses. The fixate stop bracket on the driver's seat backrest may not be installed. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 207, "Seating Systems," and 210, "Seat Belt Assembly Anchorages."

NHTSAMar 5, 2025Nationwide• MERCEDES-BENZ

Blueprint Mixed Reality (Stryker) – Guidance Instrumentation Difficulties (2025)

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

FDAMar 5, 2025AK, ID, MA +4 more• Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France

Blue Arc BA4L-800 (Blue Arc) – Headlight Adjustment Fault (2025)

Shyft Group (Shyft) is recalling certain 2024-2025 Blue Arc BA4L-800 vehicles. The headlight horizontal adjustment stud is missing a cover, allowing for horizontal adjustment of the headlight beam. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."

NHTSAMar 5, 2025Nationwide• BLUE ARC

Prasugrel Tablets (Golden State Medical) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDAMar 5, 2025Nationwide• Golden State Medical Supply Inc.

Golden Crop Candy (Blooming Import) – undeclared colors (2025)

Undeclared Allergen

Contains undeclared and unallowed colors (Blue 1, Red 40, Acid Red 18)

Class IIModerate

FDAMar 5, 2025DE, MD, MA +5 more• Blooming Import Inc.

Effaclar Duo (L'Oreal) – Benzene Contamination (2025)

Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.

Class IIModerate

FDAMar 5, 2025Nationwide• L'Oreal USA

Effaclar Duo (L'Oreal) – Benzene Levels (2025)

cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.

Class IIModerate

FDAMar 5, 2025Nationwide• L'Oreal USA

Effaclar Dermatological System (L'Oreal) – Benzene Levels (2025)

cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.

Class IIModerate

FDAMar 5, 2025Nationwide• L'Oreal USA

Golden Crop Candy (Blooming Import) – undeclared colors (2025)

Undeclared Allergen

Contains undeclared and unallowed colors (Blue 1, Red 40, Acid Red 18)

Class IIModerate

FDAMar 5, 2025DE, MD, MA +5 more• Blooming Import Inc.

TT93GP PRO MS Tire (Dunlop) – Potential Tire Defect (2025)

Sumitomo Rubber Industries, Ltd. (Sumitomo) is recalling certain Dunlop GPR-300F tires, size 110/70R17M/C 54H. The tires may have a defect that causes inner liner bulging and looseness at the tire breaker edge. As such, these tires fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 119, "New Pneumatic Tires- Other than Passenger Cars."

NHTSAMar 5, 2025Nationwide• DUNLOP

Testosterone Gel (Strides Pharma) – Benzene Presence (2025)

Presence of foreign substance: Presence of Benzene.

Class IIModerate

FDAMar 5, 2025Nationwide• Strides Pharma, Inc.

Testosterone Gel (Strides Pharma) – Benzene Presence (2025)

Presence of foreign substance: Presence of Benzene.

Class IIModerate

FDAMar 5, 2025Nationwide• Strides Pharma, Inc.

Duloxetine Capsules (Rising Pharma) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIModerate

FDAMar 5, 2025Nationwide• Rising Pharma Holding, Inc.

Gabapentin Capsules (Sun Pharmaceutical) – Cross Contamination (2025)

Cross Contamination

FDAMar 4, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Tolterodine Tartrate (Major Pharmaceuticals) – Dissolution Failure (2025)

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

FDAMar 4, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Unisom SleepMelts (Chattem) – Nitrosamine Impurity (2025)

CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.

Class IIModerate

FDAMar 4, 2025Nationwide• Chattem Inc

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