These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

2,251 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
HIGHFDA DEVICE

RaySearch Laboratories Recalls RayStation Software for Dose Calculation Error

RaySearch Laboratories AB recalled RayStation software on November 28, 2025, due to a dose calculation error. The issue affects models 17.0.0 and 17.0.1, posing a high hazard to patients. Healthcare providers should stop using the software immediately and follow the recall instructions.

RAYSEARCH LABORATORIES AB
Potential for
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HIGHFDA DEVICE

RaySearch Laboratories Recalls RayStation Software Over Dose Calculation Error

RaySearch Laboratories recalled RayStation software on November 28, 2025, due to a potential error in calculating radiation doses. The recall affects 119 units of software versions 14.0.0, 15.0.0, and 15.1.3. Healthcare providers should stop using the software immediately to ensure patient safety.

RAYSEARCH LABORATORIES AB
Potential for
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HIGHFDA DEVICE

RaySearch Laboratories Recalls RayStation Software Over Dose Calculation Error

RaySearch Laboratories recalled RayStation software on November 28, 2025, due to a serious issue with dose calculation. The software, used in radiation therapy, may not invalidate calculated doses for certain Regions of Interest. Healthcare providers and patients should stop using this software immediately.

RAYSEARCH LABORATORIES AB
Potential for
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HIGHFDA DEVICE

RaySearch Laboratories Recalls Radiation Therapy Software Due to High Risk

RaySearch Laboratories recalled a radiation therapy treatment planning system on November 28, 2025. The recall affects 10 units of RayStation software versions 11.0.0, 11.0.1, 11.0.3, and 11.0.4. The system may inaccurately calculate radiation doses for certain Regions of Interest, posing a high risk to patients.

RAYSEARCH LABORATORIES AB
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HIGHFDA DEVICE

RaySearch Laboratories Recalls Radiation Therapy Software Due to Dose Calculation Error

RaySearch Laboratories AB recalled its RayStation/RayPlan software on November 28, 2025, due to potential inaccuracies in radiation dose calculations. The issue affects certain Regions of Interest (ROIs) and could lead to incorrect treatment planning. Healthcare providers and patients should stop using the software immediately.

RAYSEARCH LABORATORIES AB
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HIGHFDA DEVICE

Medline Recalls IV Administration Sets Due to Valve Issues

Medline Industries recalled 32 units of its Deluxe Pre Op Kits on November 26, 2025. The recall stems from customer complaints about check valve components potentially sticking in open or closed positions. Patients and healthcare providers must stop using these devices immediately and follow recall instructions.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Recalls IV Administration Sets Due to Valve Malfunction

Medline Industries recalled Medline Kits containing B. Braun IV Administration Sets on November 26, 2025. The recall follows customer complaints about check valve components becoming stuck. Affected kits include the AN01 Carotid Anesth Kit-LF, SKU PHS972096014B.

Medline Industries, LP
Medline kits
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Recalled Ojaswi 12-Drawer Dressers in gray (front)
HIGH
CPSC

Ebern Designs 12-Drawer Dressers Recalled Over Tip-Over Hazard

Ebern Designs recalled Ojaswi 12-Drawer Dressers on November 26, 2025, due to a tip-over and entrapment hazard. The dressers can cause serious injuries or death if not anchored to the wall. Consumers should stop using the dressers immediately and contact the company for a refund.

Ji Nan BinCai E-Commerce Co., Ltd. dba Ebern Designs, of China
The recalled
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Recalled Ikuso Safety Gate and Tracking Label - model Door-Gen1-123
HIGH
CPSC

Ikuso Safety Gates Recalled Due to Entrapment Hazard

Ikuso recalled safety gates on November 26, 2025, due to a serious entrapment risk. The gates can allow a child’s torso to fit through, violating mandatory safety standards. Consumers should stop using the gates immediately and seek a refund.

Ikuso Safety Gates
The recalled
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Recalled KingPavonini Adult Portable Bed Rail Model BC-CBJ-X
HIGH
CPSC

KingPavonini Bed Rails Recalled for Entrapment and Asphyxiation Risk

KingPavonini recalled six models of adult portable bed rails due to serious risks of entrapment and asphyxiation. The recall affects products sold on Amazon since November 2025. Consumers must stop using these bed rails immediately and seek a refund or replacement.

Wuyi Fortune Land Sports and Leisure Products Co. Ltd., of China
The recalled
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Recalled Alinux Baby Lounger in Pink
HIGH
CPSC

Alinux Baby Loungers Recalled Over Serious Entrapment Risks

Alinux recalled its baby loungers on November 26, 2025, due to serious injury or death risks from entrapment and fall hazards. The loungers do not comply with mandatory safety standards for infant sleep products. Consumers should stop using them immediately and seek a refund.

Alinux Baby Loungers
The recalled
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Recalled Ozark Trail Tabletop 1-Burner Butane Camping Stove, model BG2247A1
HIGH
CPSC

Ozark Trail Camping Stove Recalled Over Fire and Burn Risks

Walmart recalled Ozark Trail Tabletop 1-Burner Butane Camping Stoves on November 26, 2025. The stoves pose serious burn and fire hazards due to possible explosions. Consumers should stop using the product immediately and return it for a full refund.

China Window Industry Co., Ltd, of Taipei, Taiwan
The stoves
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Recalled Sofoliana Baby Lounger
HIGH
CPSC

Sofoliana and Glotika Baby Loungers Recalled Over Fall Hazards

Bosen US recalled Sofoliana and Glotika baby loungers on November 26, 2025. The loungers pose risks of serious injury or death due to entrapment and fall hazards. The product violates mandatory safety standards for infant sleep products.

Sofoliana and Glotika Baby Loungers
The recalled
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Recalled MyOnlyStyler Root Booster Hair Dryer with the power cord cut in half for disposal
HIGH
CPSC

McLee Creations Recalls Hair Dryers Due to Electrocution Risk

McLee Creations recalled MyOnlyStyler Root Booster Hair Dryers on November 26, 2025, due to electrocution hazards. The recalled model, MOS-22, was sold in white with black bristles. Consumers should stop using the product immediately and return it for a refund.

McLee Creations
The handheld
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