nhtsa regulated Recalls

370 recalls tagged with “nhtsa regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Burlington Medical BAT Coverage Recall 1,489 Units Worldwide in 2026

Burlington Medical recalled 1,489 BAT Coverage units worldwide on 2026-02-11 after a design-related issue was identified. The recall targets attenuation material used in the device. The defect could affect the lifespan of the shielding. Healthcare providers and patients should stop using the device and follow manufacturer instructions. The recall is active as of 2026-04-08.

Burlington Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Reflexion Medical Recalls 12 RefleXion X1 Radiotherapy Systems for Software Defect (2026)

Reflexion Medical recalled 12 RefleXion X1 Radiotherapy System RXM1000 units sold to hospitals and healthcare providers in the United States after a software defect could cause a 5mm or greater misalignment and underdose. The defect occurs during angular roll corrections followed by a repeat localization, and the roll corrections from the initial localization are not carried through to treatment.

Reflexion Medical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

International Life Sciences Recalls Artelon FlexBand Plus Augmentation Devices for Endotoxin Testing

International Life Sciences recalled Artelon FlexBand Plus augmentation devices after endotoxin testing failures. The recall affects devices with REF 41054 and REF 41057 distributed worldwide. Patients and healthcare providers must stop using the devices immediately and follow manufacturer instructions for recall return.

International Life Sciences
Augmentation devices
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Vehicles & Parts
HIGH
NHTSA

Ford Explorer 2026 Recall for Transmission Valve Body Issue

Ford recalls 2024-2025 Explorer and other models for a transmission valve body defect. The valve body may have been machined incorrectly, causing reverse gear failure or unexpected forward movement in reverse or neutral. Owner notification letters were mailed April 11, 2025; dealers will replace the valve body at no charge.

Ford
Unexpected vehicle
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Vehicles & Parts
HIGH
NHTSA

Mazda CX-50 Trailer Hitch Recall Affects 2024-2025 SUVs

Mazda North American Operations is recalling certain 2024-2025 CX-50 SUVs equipped with Mazda Genuine Accessory trailer hitches sold through Mazda dealerships. The recall number is 7225C and owner notification letters were mailed April 4, 2025. The recall addresses bolts that may loosen and detach the hitch. Owners should contact their Mazda dealer to schedule a free tightening.

Mazda
A detached
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Health & Personal Care
HIGH
FDA DEVICE

Medtronic MiniMed 780G Recall 2026: 26,851 Pumps Hit Over Software Defects

Medtronic MiniMed recalled 26,851 MiniMed 780G insulin pumps sold worldwide, including the United States and Israel. Three software defects tied to updates 6.60, 6.61, and 6.62 could misdose insulin. Stop using the affected pumps and follow the recall letter for instructions.

Medtronic MiniMed
Three software
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Health & Personal Care
HIGH
FDA DEVICE

ReCor Medical Paradise Ultrasound Renal Denervation System Recall 2026: 24 Catheters PRDS-068-02

ReCor Medical Inc. has issued an active recall for 24 Paradise ultrasound renal denervation catheters distributed nationwide in nine states. The devices were nonconforming and were supposed to be scrapped and not for human use. Healthcare providers and patients should stop using the devices immediately and await manufacturer recall instructions.

ReCor Medical
Due to
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Health & Personal Care
HIGH
FDA DRUG

Teva Metoprolol Succinate 50 mg Extended-Release Recall 2026 Following Failed Dissolution Specs (67,

Teva Pharmaceuticals recalled 67,043 bottles of Metoprolol Succinate Extended-Release Tablets, 50 mg, distributed nationwide. The FDA enforcement report cites Failed Dissolution Specifications as the hazard. Health care providers and patients should stop using this product immediately and contact Teva for guidance.

METOPROLOL SUCCINATE
Failed Dissolution
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Food & Beverages
HIGH
FDA FOOD

Mangalm Tops GOLD Mixed Pickle Recalled for Erucic Acid Adulteration Risk (2026)

Mangalm LLC recalled Tops GOLD Mixed Pickle sold in California, Nevada, Oregon, Utah and Washington after FDA enforcement. The product may be adulterated with erucic acid from mustard oil. Consumers who purchased it should not eat it and should contact Mangalm for refund or replacement via email.

Mangalm
Potential adulteration
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Health & Personal Care
HIGH
FDA DEVICE

I.T.S. Ulna Locking Plate Systems Recalled Over MRI Heating Risk (2026)

I.T.S. GmbH recalled 120 units of its DUL and UOL ulna locking plate systems distributed nationwide to U.S. healthcare providers after MRI safety testing showed higher RF-induced heating. The updated testing found temperature increases under certain MRI conditions not reflected in the Instructions for Use. Healthcare facilities and patients should stop using the devices immediately and follow the厂

I.T.S. GmbH
Updated MRI
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Health & Personal Care
HIGH
FDA DEVICE

I.T.S. GmbH Distal Humeral Plates Recalled for MRI Heating Risk — 12,059 Units (2026)

I.T.S. GmbH recalled 12,059 Distal Humeral Plates with Angular Stability due to MRI heating risk. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than reflected in the IFU. Healthcare providers and patients should stop using the device and follow recall instructions.

I.T.S. GmbH
Updated MRI
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Health & Personal Care
HIGH
FDA DEVICE

ITS GmbH Recalled 510 I.T.S Straight Plate with Angular Stability Over MRI Heating Risk (2026)

ITS GmbH recalled 510 units of the I.T.S Straight Plate with Angular Stability after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions. The recall covers multiple article numbers across forearm and straight plates and distributions nationwide in the United States. No injuries or incidents have been reported at this time. Healthcare providers andpatients

I.T.S. GmbH
Updated MRI
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Health & Personal Care
HIGH
FDA DEVICE

I.T.S. Screw System Recalled for MRI Heating Risk in 5,568 Units (2026)

I.T.S. GmbH has recalled 5,568 units of the I.T.S. Screw System sold nationwide in the United States after MRI safety tests showed higher RF-induced temperature increases under some MRI conditions than the IFU outlined. The defect involves MRI RF heating that could burn patients. Patients and healthcare providers should stop using the device immediately and follow the recall instructions.

I.T.S. GmbH
Updated MRI
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Health & Personal Care
HIGH
FDA DRUG

Dukal BZK Antiseptic Towelettes Recalled for CGMP Deviations (2026)

Nationwide recall of Dukal BZK Antiseptic Towelettes due to CGMP deviations. The products are manufactured for Dukal, LLC in Ronkonkoma, NY and distributed across the United States. Stop using immediately and contact ACME United Corporation for guidance.

Dukal
CGMP Deviations
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Health & Personal Care
HIGH
FDA DRUG

Acme United MED NAP BZK Antiseptic Towelettes Recalled in 2026 (100-Count)

Acme United Corporation recalled Med Nap BZK Antiseptic Towelettes, 100-count, distributed nationwide. The FDA-listed CGMP deviations raise concerns about manufacturing quality and product safety. Consumers and healthcare providers should stop using the product and follow the recall letter for guidance.

Acme United Corporation
CGMP Deviations
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