mandatory standard violation Recalls

147 recalls tagged with “mandatory standard violation”.

Recalled Bearlala Baby Lounger Top View
HIGH
CPSC

Bearlala Baby Loungers Recalled Over Entrapment and Fall Hazards (2025)

Bearlala baby loungers sold on Walmart.com by Nuoxuann are recalled. The recall cites a violation of the mandatory Infant Sleep Products standard. The loungers have sides that are too low and foot openings that are wider than allowed, creating fall and entrapment hazards. Consumers should stop using the loungers immediately and contact Nuoxuann for a full refund.

Bearlala
The recalled
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Recalled Zippee Activity Toy with Spherical Ends on Silicone Strings
HIGH
CPSC

Zippee Silicone Activity Toys Recalled for Choking Hazard in 2025

Zippee silicone activity toys imported by Mobi Games are recalled due to a choking hazard. The recall involves a teal silicone cylinder with six string holes and spherical ends on five strings. Stop using the recalled toy immediately and contact Mobi Games for a full refund.

Zippee
The recalled
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Sheath Recalled Over Risk of Ceramic Tip Breakage

Olympus recalled 94 units of its 10 Fr. endoscopic sheath on November 11, 2025, due to complaints of the ceramic tip breaking. The defect poses a high risk for patients undergoing urological procedures. Healthcare providers and patients must stop using the device immediately.

Olympus Corporation of the Americas
Complaints of
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Recalled Umeyda Shortsleeve Nightgown – Baby Pink Stripe
HIGH
CPSC

Umeyda Nightgowns Recalled for Burn Risk in 2025 Sold on Amazon

Umeyda recalled 100% cotton girls' nightgowns sold on Amazon. The recall involves nightgowns with a pocket and a front button closure. The garments do not meet mandatory flammability standards and pose a burn risk. Stop using them and email ameyda123@163.com for a full refund.

Umeyda
The recalled
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Peptic Ulcer Test Recalled 12 Units in 2025

GET TESTED INTERNATIONAL AB recalled 12 Peptic Ulcer Tests for H. pylori sold nationwide through multiple retailers. The tests were distributed without FDA premarket approval or clearance. Health professionals and patients should stop using the tests immediately and await recall instructions.

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

GET TESTED INTERNATIONAL Gut Microbiome Test Large Recalled for Premarket-Approval Violation (2025)

GET TESTED INTERNATIONAL recalled 3 Gut Microbiome Test Large kits sold nationwide in the United States after regulators flagged distribution without premarket approval. The recall centers on a lack of FDA clearance for the device. Consumers and healthcare providers should stop using the device immediately and follow recall instructions.

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

GET TESTED INTERNATIONAL AB Thyroid TSH Test Recalled Over PMA Issue (1,916 Units)

GET TESTED INTERNATIONAL AB recalled 1,916 Thyroid TSH Tests distributed nationwide in the United States. The devices were distributed without premarket approval or clearance. Healthcare providers and patients should stop using the tests and follow manufacturer instructions immediately.

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

GET TESTED INTERNATIONAL AB 8 in 1 STI Test Kit Recalled for 2,043 Units in 2025

GET TESTED INTERNATIONAL AB recalled 2,043 units of an 8 in 1 STI Test Kit sold nationwide in the United States. The recall is for distribution without premarket FDA approval or clearance. Consumers should stop using the device and follow the manufacturer’s recall instructions or contact the company for guidance.

GET TESTED INTERNATIONAL AB
Distribution without
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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 NAD Profile Test Recall 36 Units for Premarket Approval Issue (2025)

GET TESTED INTERNATIONAL AB recalled 36 NAD Profile Tests distributed nationwide in the United States after regulators found distribution without premarket approval. The devices were distributed without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow recall instructions; contact GET TESTED INTERNATIONAL AB or your health‑ca

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

GET TESTED INTERNATIONAL AB Serotonin Test Recall 12 Units (2025)

GET TESTED INTERNATIONAL AB recalled 12 serotonin test devices distributed nationwide in the United States after the device was distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions. Contact GET TESTED INTERNATIONAL AB for instructions or consult your healthcare provider.

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

GET TESTED INTERNATIONAL AB MPOX Test Recall for 4 Units Distributed in US (2025)

GET TESTED INTERNATIONAL AB recalled 4 MPOX Test devices distributed nationwide in the United States after distribution without premarket approval. The recall cites a regulatory violation rather than an injury risk. Healthcare providers and patients should stop using the device immediately and await instructions from the manufacturer.

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

GET TESTED INTERNATIONAL AB Candida Test Recalled for 166 Units in 2025

GET TESTED INTERNATIONAL AB recalled 166 units of its Candida Test distributed nationwide in the United States. The device was distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions from the manufacturer.

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

GET TESTED INTERNATIONAL AB Recalls 16 Food Intolerance Test Medium Devices (2025)

GET TESTED INTERNATIONAL AB recalled 16 Food Intolerance Test Medium devices distributed nationwide in the United States. The devices were distributed without premarket approval or clearance. Consumers should stop using the device immediately and follow the manufacturer’s recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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