nhtsa regulated Recalls

370 recalls tagged with “nhtsa regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Fortress Introducer Sheath System 386594 Recall Expanded; 2,500 Units Worldwide Distribution (High-R

Fortress Introducer Sheath System recalled 2,500 units linked to label mispackaging. The devices were distributed worldwide, including 15 U.S. states and numerous international markets. The incorrect pouch label lists the 4F version reference and unique device identifier instead of the packaged 6F version. Healthcare providers must stop use and follow manufacturer recall instructions.

Fortress Introducer Sheath System
Units may
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Health & Personal Care
HIGH
FDA DEVICE

Over 4,300 S.I.N. Implant EPIKUT Dental Implants Recalled Due to Quality Concerns

S.I.N. Implant System Ltda recalled 4,367 dental implants after reports of potential packaging damage. Improper temperature and storage conditions may compromise product quality and performance. Patients and healthcare providers should stop using these implants immediately and follow the manufacturer's instructions for return.

S.I.N. Implant System Ltda
Dental implants
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Vehicles & Parts
HIGH
NHTSA

Kia Telluride Exterior Trim Recall for 2023-2025 Models (2027 Recall)

Kia America, Inc. is recalling 2023-2025 Kia Telluride SUVs sold through Kia dealers nationwide after interim notices warned that door belt molding trim can delaminate and detach. A detached trim piece can become a road hazard for other vehicles and increase the risk of a crash. Owners should contact Kia customer service at 800-333-4542 for inspection and repair.

Kia
A detached
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Vehicles & Parts
HIGH
NHTSA

Ford 2025 Expedition Recalled for Brake Software Issue; OTA Update Available

Ford Motor Company recalls 2025 Expedition and other models over a brake booster software fault. The Electronic Brake Booster module may fail while driving or during ADAS use, reducing power brake assist. Ford will update the module software OTA or via dealer free of charge. Owner notifications started August 22, 2025. Contact Ford at 1-866-436-7332 for details and recall 25S77.

Ford
An unexpected
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Health & Personal Care
HIGH
FDA DEVICE

Zap Surgical Systems ZAP-X Radiosurgery System Recalled for 17 Units Worldwide in 2025

Zap Surgical Systems recalled 17 ZAP-X Radiosurgery System units worldwide, including US states FL, CO, NJ, NY and several countries. A software defect could cause the collimator to collide with patient shoulders or the patient table during long gantry moves after proximity errors. Clinicians and patients should stop using the device and follow recall instructions from the manufacturer.

Zap Surgical Systems
If the
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Health & Personal Care
HIGH
FDA DEVICE

Home Health US Recalled 4,661 One Step Sterile Lancets for Single Use (2025)

Home Health US recalled 4,661 One Step Sterile Lancets for Single Use sold nationwide through Amazon. The recall cites incorrect or missing Unique Device Identifier codes. Consumers should stop using the lancets immediately and follow the recall instructions from Home Health US or their healthcare provider.

Home Health US
Due to
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Vehicles & Parts
HIGH
NHTSA

Hyundai IONIQ 5 2025 Recall for High Voltage Battery Bus Bar Tightening Short Circuits (2025)

Hyundai Motor America recalls 2025 IONIQ 5 vehicles due to a potentially loose bus bar in the high voltage battery system. The recall covers 2025 IONIQ 5 models. Hyundai says a short circuit could cause a fire. Owners should park outside away from structures until the remedy is complete and contact Hyundai at 1-855-371-9460. The recall number is 280.

Hyundai
An electrical
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Recalled HydroTech 5/8-inch x 25-foot Expandable Burst-Proof Hose
MEDIUM
CPSC

Winston Products HydroTech 5/8-Inch Expandable Burst-Proof Hose Recall 2025

Winston Products recalled HydroTech 5/8-inch Expandable Burst-Proof Hoses sold through Home Depot and Walmart. The hoses manufactured on or before August 31, 2024 can burst and create an impact hazard and temporarily impair hearing. Consumers should stop using the hoses immediately and contact Winston Products for a full refund.

Winston Products
The recalled
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Health & Personal Care
HIGH
FDA DRUG

Ascend Laboratories Amlodipine and Olmesartan Medoxomil Recall for Low Dissolution 8,568 Bottles in

Ascend Laboratories recalls 8,568 bottles of Amlodipine and Olmesartan Medoxomil tablets due to failed dissolution specifications. The recall covers products manufactured by Alkem Laboratories in India and distributed nationwide in the USA. The defect involves low dissolution results. Stop use immediately and contact Ascend Laboratories for guidance.

Amlodipine and Olmesartan Medoxomil
Failed Dissolution
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Health & Personal Care
HIGH
FDA DEVICE

Summa Therapeutics Recalls 22 Finesse BTK Multicath Angioplasty Balloons Over Burst Specifications (

Summa Therapeutics recalled 22 units of the Finesse BTK Multicath Injectable Angioplasty Balloon Catheter sold to healthcare facilities in New Jersey and Florida. The balloon may not meet burst specifications, raising risk during angioplasty. Healthcare providers must stop using the device immediately and follow recall instructions from Summa Therapeutics.

Finesse BTK Multicath
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

C.R. Bard Recall: SureStep Foley Tray System Lubri-Sil I.C. Complete Care Contains Incorrect Inserts

C.R. Bard Inc. recalls 4,300 SureStep Foley Tray System Lubri-Sil I.C. Complete Care infection control Foley catheter trays nationwide in the United States. The trays may contain incorrect inserts that misrepresent material composition. The mismatch could trigger infections or allergic reactions. Health care providers should stop use and follow recall instructions immediately.

C.R. Bard
Foley catheter
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Health & Personal Care
HIGH
FDA DEVICE

Stryker Communications Recalls 40 Medical Light Systems Over Powder Coating Chip Risk (2025)

Stryker Communications recalls 40 surgical light systems nationwide after reports of stress lines in the powder coating. The devices include CH00000001 and the SLX to Oculan NFC Upgrade Kit, P60034. The recall is active as of July 15, 2025. Patients and healthcare providers should stop using the devices immediately and follow manufacturer recall instructions.

Stryker Communications
Surgical lights
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Health & Personal Care
HIGH
FDA DEVICE

BioFire Defense FilmArray NGDS Warrior Panel NGDS-ASY-0007 Recall 130 Kits in 2025

BioFire Defense recalled 130 FilmArray NGDS Warrior Panel NGDS-ASY-0007 kits distributed nationwide in the United States. The recall cites an increased risk of internal control failures when testing positive blood cultures. Clinicians should stop using the device immediately and follow recall instructions provided by BioFire Defense. Notification is by letter to affected facilities.

BioFire Defense
FilmArray NGDS
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Tag Statistics

Total Recalls
370

Related Tags

electrical hazardchemical hazardsuffocation risktip over riskinfant productelderly productadult productbattery poweredlithium batteryimmediate actionstop use immediatelyreturn for refund