cpsc regulated Recalls

1,716 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Tornier Recalls Surgical Screws Over Labeling Error

Tornier recalled 427 units of its Perform Reversed Perip Screws on December 19, 2025, due to incorrect labeling. The screws, meant to be 5.0mmx18mm, were misidentified as 5.00mmx14mm. This labeling issue can lead to surgical delays or increased risk of mechanical failure if unnoticed.

Tornier
A specific
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Health & Personal Care
HIGH
FDA DRUG

Zydus Pharmaceuticals Recalls TraZODONE Tablets Over Defects

Zydus Pharmaceuticals recalled over 2,100 bottles of TraZODONE Hydrochloride Tablets on December 19, 2025. Some tablets have surface dents that may affect medication integrity. Consumers should stop using the product immediately and seek guidance from healthcare providers.

Zydus Pharmaceuticals
Failed Tablet/Capsule
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Health & Personal Care
HIGH
FDA DEVICE

ICU Medical Recalls Spinal Tray Syringes Due to Leakage Risk

ICU Medical recalled 64,290 spinal tray syringes on December 19, 2025, due to potential cracks in the syringe collar. The cracks may cause blood leakage and delays in blood draws or fluid delivery. Affected syringes were distributed nationwide across 13 states.

ICU Medical
Affected lots
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Health & Personal Care
HIGH
FDA DRUG

Novo Nordisk Recalls Wegovy Injection Due to Contamination Risk

Novo Nordisk recalled Wegovy (semaglutide) Injection on December 19, 2025, due to hair found in a prefilled syringe. The recall affects products distributed nationwide in the United States. Consumers should stop using the product immediately and contact their healthcare provider.

Wegovy
Presence of
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls AXIOS Stent Due to Deployment Risks

Boston Scientific recalled 557 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. Increased reports of stent deployment and expansion issues prompted this recall. The defect may require additional medical intervention to resolve deployment failures.

Boston Scientific
Increased reports
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Food & Beverages
HIGH
FDA FOOD

Troemner Farm Recalls Cookies Over Undeclared Allergens

Troemner Family Farm recalled 56 units of Pfeffernusse Cookies on December 19, 2025, due to undeclared allergens. The cookies contain soy, wheat, and milk, posing a serious risk to consumers with allergies. The affected products were distributed in Michigan.

Troemner Farm
undeclared soy,
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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical Recalls MRI Systems Over High-Pressure Hazard

Canon Medical Systems recalled 22 MRI systems on December 19, 2025, due to a potential ice formation hazard in the venting system. The defect could lead to a pressure build-up and helium gas release. Healthcare providers must stop using the affected devices immediately.

Canon Medical System, USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical Recalls Alphenix INFX-8000C X-Ray System Over Safety Risk

Canon Medical System, USA recalled 172 Alphenix INFX-8000C x-ray systems on December 19, 2025, due to loose screws in the ceiling movement gear. This defect can lead to loss of lateral movement, abnormal noise, and sensor errors. Healthcare providers must stop using the device immediately.

Canon Medical System, USA
It has
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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical System Recalls Interventional X-Ray Systems Over Safety Risk

Canon Medical System, USA recalled 332 units of the Alphenix INFX-8000V X-ray system on December 19, 2025. Loose fixing screws may hinder ceiling movement and cause sensor errors. Healthcare providers must stop using the device immediately and follow manufacturer's instructions.

Canon Medical System, USA
It has
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Food & Beverages
HIGH
FDA FOOD

Gregory's Foods Cookie Dough Recalled for Undeclared Peanuts

Gregory's Foods recalled 308 cases of White Chocolate Macadamia Nut frozen cookie dough on December 19, 2025. The product contains undeclared peanuts, posing a serious allergy risk. Consumers should not consume the product and seek refunds.

Gregory's Foods
Undeclared peanuts.
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Health & Personal Care
HIGH
FDA DEVICE

Tyber Medical Recalls VOLT Wrist Treatment System Due to Hazard

Tyber Medical recalled 100 units of its VOLT Wrist Treatment System on December 19, 2025. The recall stems from a manufacturing defect that affects the thread orientation of anatomical left plates. Healthcare providers and patients should stop using the device immediately.

Tyber Medical
The supplier
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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical MRI Systems Recalled Over High-Pressure Risk

Canon Medical Systems recalled 34 MRI systems due to a risk of helium gas release. The recall affects models MRT-3020 and MEXL-3020 distributed across 13 states. Healthcare providers should stop using these devices immediately and follow recall instructions.

Canon Medical System, USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Issues Recall for Stent Due to Deployment Issues

Boston Scientific recalled 588 units of its *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. The recall follows multiple reports of stent deployment and expansion issues, posing serious risks during medical procedures.

Boston Scientific
Increased reports
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Recalled SereneLife 48” Above-Ground Pool Models SLPORND15 and SLPORND1
MEDIUM
CPSC

SereneLife Recalls Above-Ground Pools Due to Drowning Hazard

SereneLife recalled all above-ground pools 48 inches and taller on December 18, 2025. The recall affects models SLPORND15 and SLPORND18 due to a design flaw that poses a drowning risk to children. Consumers must stop using the pools immediately and contact SereneLife for a full refund.

SereneLife Home
The compression
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Food & Beverages
HIGH
FDA FOOD

CATAO MARKET Recalls Cuban Loaf Cake Due to Undeclared Color Additive

CATAO MARKET recalled 775 cases of Authentic Cuban Loaf Cake on December 18, 2025. The recall stems from an undeclared color additive, FD&C Yellow #5, which poses a significant health risk. Consumers should not eat the product and should seek a refund or replacement.

CATAO MARKET
Undeclared colors
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Food & Beverages
HIGH
FDA FOOD

CATAO MARKET Recalls Cuban Loaf Cake Over Undeclared Color Additive

CATAO MARKET recalled 520 master cases of its Authentic Cuban Loaf Cake Raisins on December 18, 2025. The recall occurred due to undeclared FD&C Yellow #5, which poses a high allergy risk. The affected products were distributed only in Florida and have best by dates from December 18, 2025, to March 18, 2026.

CATAO MARKET
Undeclared colors
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Health & Personal Care
HIGH
FDA DRUG

Imprimis NJOF Recalls Intraocular Injection Over Glass Particles

Imprimis NJOF, LLC recalled 314 boxes of Tri-Moxi+¿ intraocular injections on December 18, 2025. The recall is due to the presence of glass-like particles in the product. Consumers and healthcare providers should stop using the product immediately and contact the company for further guidance.

Imprimis NJOF
Presence of
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Health & Personal Care
HIGH
FDA DEVICE

Rifton Equipment Recalls TRAM Lift Device Over Strap Hazards

Rifton Equipment recalled 3,238 TRAM powered lift devices on December 18, 2025, due to a risk of fraying body support straps. This recall affects models K310 sold worldwide, including the US, Europe, and Australia. Healthcare providers and patients must stop using the devices immediately to prevent injury.

Community Products
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Rifton Recalls E-Pacer Gait Training Device Over Fraying Risk

Rifton Equipment recalled 470 E-Pacer gait training devices on December 18, 2025. The body support strap may fray, posing a risk to users. Health care providers and patients must stop using the device immediately.

Community Products
Potential for
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