mandatory standard violation Recalls

147 recalls tagged with “mandatory standard violation”.

Recalled Besslly Halloween Pumpkin Carving Kit
CRITICAL
CPSC

Besslly Halloween Pumpkin Carving Kit CHD-014-2 Recalled for Battery Ingestion Risk (2026)

Besslly recalled its CHD-014-2 Halloween Pumpkin Carving Kit sold on Amazon after the tea lights’ button-cell batteries pose an ingestion risk. The recall involves five tea lights with 15 button batteries and a set of carving tools, emoticon stickers, a handbag, and gloves, and it lacks the Reese’s Law warnings. Stop using the recalled kit now and email tingjmng@outlook.com to receive a fullrefund

Halloween Pumpkin Carving Kits
The recalled
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Recalled SCUBAPRO Monorail Weight Pockets Shown in all colors and sizes
HIGH
CPSC

SCUBAPRO Recalls Monorail Weight Pockets for BCDs Over Entrapment Risk (2026)

SCUBAPRO recalled Monorail Weight Pockets for BCDs sold by retailers worldwide on 2026-04-09 after safety reviews identified a serious entrapment risk. The recall notes a potential for entrapment and drowning and cites missing warning labels. Consumers should stop using the recalled bed rails and contact SCUBAPRO for a full refund.

SCUBAPRO
The D-ring
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Recalled ELENKER Bed Rail - model HFK-5124
CRITICAL
CPSC

ELENKER Portable Bed Rails Recalled Over Entrapment Risk (2026)

ELENKER recalled three models of portable bed rails sold on Amazon by Fuzhou Shiahaha Cultural Industry Development. The rails can entrap users or create a gap with the mattress, posing a risk of suffocation and death, and they lack required hazard warnings. Consumers should stop using the rails immediately and contact the company for a full refund.

ELENKER Portable Bed Rails
The recalled
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Recalled Aisstxoer Adult Bike Helmet (pink)
HIGH
CPSC

Aisstxoer Adult Bicycle Helmets Recalled Over Head Injury Risk (2026)

Aisstxoer adult bicycle helmets sold on Amazon by YXTDZ Store are being recalled. The helmets fail to meet mandatory safety standards for impact attenuation and stability, creating a serious head-injury risk. Stop using the recalled helmet now and contact YXTDZ Store for a full refund; destroy the helmet and email a photo to yxtdzamz@126.com.

Aisstxoer Adult Bicycle Helmets
The recalled
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Recalled Goregent Infant Walker
HIGH
CPSC

Goregent Infant Walkers Recalled for Fall Hazard on Amazon (2026)

Goregent is recalling Goregent-branded infant walkers sold on Amazon. The recalled walkers can fit through a standard doorway and fail to stop at the edge of a step. Parents should stop using the recalled walkers immediately and contact Goregent Official Store for a full refund.

Infant Walkers
The recalled
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Health & Personal Care
HIGH
FDA DEVICE

Brahms PlGF Plus KRYPTOR 859075N Recall Expands to 5,254 Units Worldwide (2026)

Brahms GmbH recalled 5,254 units of the PlGF Plus KRYPTOR in vitro diagnostic test worldwide after reports of QC values out of range at QC Level 1. The issue may cause falsely elevated sFlt-1/PlGF ratios and higher risk classifications for preeclampsia progression. Stop using the device immediately and follow manufacturer recall instructions.

Brahms GmbH
Customers have
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Recalled Toddler Bike Helmet
HIGH
CPSC

ProRider Recalls Bicycle Helmets Over Serious Head Injury Risk

ProRider recalled several models of bicycle helmets on March 12, 2026, due to a serious risk of head injury. The helmets do not meet mandatory safety standards and can fail in a crash. Consumers should stop using these helmets immediately and seek a refund.

ProRider
The recalled
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Recalled Kluster Fun Tabletop Magnet Chess Game (Sold in White Pouch)
HIGH
CPSC

Stoney Games Recalls Kluster Magnet Chess Games Over Ingestion Risk

Stoney Games recalled Kluster Fun Tabletop Magnet Chess Games on March 12, 2026, due to a serious ingestion hazard. The games contain loose, high-powered magnets that can be swallowed by children, posing a risk of severe injury or death. Consumers should immediately stop using the games and contact Stoney Games for replacement options.

Stoney Games
The recalled
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Health & Personal Care
HIGH
FDA DEVICE

Cook Medical Blue Rhino G2-Multi Tracheostomy Introducer Set Recalled for Expiration Date Labeling —

Cook Medical recalled 916 units of the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set worldwide after discovering expiration dates exceeded true shelf life. The recall affects multiple reference part numbers and order numbers. Healthcare providers should stop using the device immediately and follow Cook’s instructions for recall notification.

Cook
Products from
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Health & Personal Care
HIGH
FDA DEVICE

Philips Azurion 5 M12 X-ray System Recall 2026: 345 Worldwide Units Affected

Philips Medical Systems Nederland B.V. recalled 345 Azurion 5 M12 X-ray systems distributed worldwide after reports that X-ray imaging may not start or may run intermittently when using the wired foot switch. The defect could affect imaging during patient care. Hospitals should stop using the device immediately and follow the recall instructions in the notification letter.

Philips Medical Systems Nederland B.V.
Philips has
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Health & Personal Care
HIGH
FDA DEVICE

Synthes Bone Taps Recall 33-Unit Lot Swap Causes Incorrect Threading (2026)

Synthes bone taps recalled nationwide in the United States after a lot swap affected 33 units sold through multiple retailers. The defect is an incorrect thread caused by a lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8. Healthcare providers should stop using these devices immediately and follow recall instructions from Synthes.

Synthes
A full
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Health & Personal Care
HIGH
FDA DEVICE

Mentor Artoura Breast Tissue Expanders Recall for Dull Needle Tips (2026)

Mentor Texas, LP is recalling Artoura Breast Tissue Expanders with infusion sets worldwide, including the United States and Canada. The infusion sets may contain dull or blunt needle tips that are difficult to advance or may break. Patients and healthcare providers should stop using the device and follow recall instructions.

Mentor
Infusion sets
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Health & Personal Care
HIGH
FDA DEVICE

Merit Medical BioFlo DuraMax Catheter Recall 2026: 47,153 Units Worldwide

Merit Medical Systems recalled 47,153 BioFlo DuraMax Catheters distributed worldwide through medical distributors after a design defect in the 16F dual-valved splittable sheath introducer may fail to split as intended. The defect can cause hemorrhage, foreign bodies, and delays in procedures. Clinicians and patients should stop using the device immediately and follow recall instructions from Merit

Merit Medical Systems
16F dual-valved
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Health & Personal Care
HIGH
FDA DEVICE

Burlington Medical Blockers Recalled for Attenuation Degradation in 51 Units Worldwide (2026)

Burlington Medical recalled 51 Blocker devices sold worldwide after a recall notice. The devices may degrade attenuation over time, shortening their lifespan. Stop using the devices immediately and follow the manufacturer’s recall instructions. Contact Burlington Medical, LLC or your healthcare provider for guidance. Distribution is worldwide.

Burlington Medical
Potential for
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