nhtsa regulated Recalls

370 recalls tagged with “nhtsa regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Get Tested International AB Leaky Gut Test Recalled for Lack of FDA Approval (31 Units)

GET TESTED INTERNATIONAL AB recalled 31 Leaky Gut Test devices distributed nationwide in the United States after the product was found to be distributed without FDA premarket approval. The devices test for gut health but lack FDA clearance. Consumers should stop using the device immediately and contact the manufacturer for instructions.

Get Tested International AB
Distribution without
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalled 754 Units of 2 in 1 Trichomonas / Gardnerella Test (2025)

GET TESTED INTERNATIONAL AB recalled 754 units of a 2 in 1 Trichomonas / Gardnerella Test distributed nationwide in the United States after regulators found distribution without premarket approval or clearance. The device was distributed without FDA clearance. Patients and healthcare providers should stop using the test immediately and follow the manufacturer’s recall instructions by contactingGET

GET TESTED INTERNATIONAL AB
Distribution without
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Blood Type Test Recalled for Lack of Premarket Approval (47 Units) 2025

GET TESTED INTERNATIONAL AB recalled 47 Blood Type Test units distributed nationwide in the United States after discovering the device was distributed without FDA premarket approval or clearance. The hazard is distribution without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and contact GET TESTED INTERNATIONAL AB for instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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Vehicles & Parts
HIGH
NHTSA

Nissan Recalls 2025 Sentra for Driver Seat Frame Security Issue

Nissan North America, Inc. recalls certain 2025 Sentra vehicles. The driver’s seat frame may not be fully secured to the outer side of the seat track, potentially failing to meet FMVSS 207 and 210. Dealers will inspect and replace the driver's side lower seat frame assembly as necessary at no charge; owner letters were mailed May 1, 2025.

Nissan
An unsecured
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Health & Personal Care
HIGH
FDA DEVICE

STRYKER NICO Myriad Handpiece Recall for 39,148 Units Worldwide (2026)

STRYKER recalled 39,148 NICO Myriad Handpieces sold worldwide due to latex in packaging that could trigger allergic reactions. The latex-containing tape secures components within packaging. Healthcare providers and patients should stop using the device immediately and follow the recall instructions from Stryker.

Stryker
Tape used
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Health & Personal Care
HIGH
FDA DRUG

Nivagen Zinc Oxide Ointment Recall 912 Containers Over cGMP Deviations (2025)

Nivagen Zinc Oxide Ointment 20% skin protectant, manufactured in India for Nivagen Pharmaceuticals and distributed nationwide in the USA, is recalled. The recall covers 912 containers. The defect cited is cGMP deviations. Consumers and healthcare providers should stop using the product and follow guidance from Blossom Pharmaceuticals or a healthcare professional.

Nivagen Zinc Oxide
cGMP deviations
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Recalled Halloween-themed Skeleton Wax Candle
HIGH
CPSC

Kroger Recalls Halloween Skeleton Wax Candles for Fire Hazard (2025)

The Kroger Co. recalls Halloween-themed Skeleton Wax Candles sold at Kroger stores due to a fire hazard. The candle contains flammable ornaments that create a burn risk. Consumers should stop using the candle immediately and return it to any Kroger store for a full refund.

Kroger
The candle
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Health & Personal Care
HIGH
FDA DEVICE

Olympus HX-400U-30 Recall: 7,803 Endoscopic Ligation Devices Recalled in 2025

Olympus Corporation of the Americas recalled 7,803 HX-400U-30 single‑use ligating devices distributed nationwide in the United States. The ligation loop may fail to release or detach. Hospitals and clinics should stop using the device immediately and follow the recall instructions from Olympus or their healthcare providers.

Olympus
Potential that
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Health & Personal Care
HIGH
FDA DEVICE

B. Braun Medical Blood Administration Set Recall 7,344 Units Over Backflow Risk (2025)

B. Braun Medical recalled 7,344 Blood Administration Sets used with Infusomat Space, Outlook Pump, and Vista Basic Pump. The devices may allow backflow from secondary (piggyback) IV containers into primary IV containers and cannot be primed. Hospitals and healthcare providers should stop using the devices immediately and follow manufacturer instructions.

B. Braun Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

B Braun Medical IV Administration Set Recall for Backflow Risk (490566) 2025

B Braun Medical recalled its IV Administration Set used with Infusomat Space Large Volume Pumps and related models. The recall cites backflow of medication from secondary to primary IV containers and an occlusion that prevents priming. Hospitals and clinicians should stop using the device immediately and follow manufacturer recall instructions.

B Braun Medical
Potential for
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Health & Personal Care
HIGH
FDA FOOD

Avion Pharmaceuticals Prenate Chewable Prenatal Vitamin Recalled for Undeclared Soy (804 Bottles, 5

Avion Pharmaceuticals recalled 804 bottles of Prenate Chewable prenatal vitamins shipped to 17 states after tests found undeclared soy and a boron labeling error. The product lists boron as 250 mg per serving instead of 250 mcg per serving. Consumers should not take the product and should contact Avion Pharmaceuticals for refund or replacement.

Avion Pharmaceuticals
Undeclared Soy.
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Health & Personal Care
HIGH
FDA DEVICE

B. Braun Medical Inc. IV Administration Set Recalled for Backflow and Priming Occlusion (490407)

B Braun Medical Inc. recalled 10,896 IV administration sets globally due to backflow risk and occlusion. The recall covers the IV ADMIN SET W/ CARESITE EXT SET with Catalog Number 490407 used with BBMI pumps. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.

BB Braun Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

B Braun Medical Inc. Recalls 28,344 IV Administration Sets Linked to Backflow and Occlusion Risks (Z

B Braun Medical Inc. recalls 28,344 IV administration sets used with several BBMI infusion pumps after reports of backflow and occlusion risks. The recall covers a catalog number 470179 device distributed worldwide including the U.S., Canada, Germany, Guatemala and Singapore. The issue involves potential backflow from secondary IV containers into primary containers and the inability to prime the管.

BBraun Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

B. Braun Medical Recalls 32,500 Caresite Extension Sets for IV Pumps (2025)

B. Braun Medical recalled 32,500 Caresite Extension Sets used with Infusomat Space, Outlook, and Vista Basic IV pumps worldwide. The devices pose a backflow and occlusion risk in the primary IV line. Hospitals and healthcare providers should stop using the device immediately and follow the recall instructions.

B. Braun Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

BBraun Medical Blood Administration Set Recall 5,448 Units (2025)

BBraun Medical recalled 5,448 Blood Administration Sets used with Infusomat Space pumps worldwide sold to hospitals. The recall cites potential backflow of medication from secondary piggyback IV containers into primary IV containers and an inability to prime. Healthcare facilities should stop using the sets immediately and follow recall instructions from B. Braun Medical.

B. Braun Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

B Braun Medical IV Administration Sets Recall Over Backflow and Occlusion Risk (2025)

B Braun Medical Inc. recalls 190,625 IV administration sets worldwide, including US and Canada, for risk of backflow from secondary to primary IV containers and occlusion that prevents priming. The recall affects BBMI’s Infusomat Space, Outlook Pump, and Vista Basic Pump compatible sets. Stop-use immediately and follow recall instructions.

BBraun Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

B. Braun Medical SAFELINE IV Sets Recalled for 46,250 Units Over Backflow Risk (2025)

B. Braun Medical recalled 46,250 SAFELINE IV sets sold worldwide on Oct. 29, 2025. The devices pose a backflow risk from secondary piggyback IV containers into primary lines and may fail to prime due to occlusion. Hospitals and patients using Infusomat Space Large Volume Pump, Outlook Pump, or Vista Basic Pump with SAFELINE sets should stop use immediately and await manufacturer instructions.

B. Braun Medical
Potential for
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Tag Statistics

Total Recalls
370

Related Tags

immediate actionstop use immediatelyreturn for refundreplacement availablefederal law violationcpsc regulatedmandatory standard violationelectronicchemical hazardadult productoutdoorgarage
    nhtsa regulated Recalls | RecallRadar