stop use immediately Recalls

2,229 recalls tagged with “stop use immediately”.

Health & Personal Care
HIGH
FDA DEVICE

BD Catheter Recalled Due to Incorrect Expiration Labeling

BD recalled 149,310 hydrophilic catheters due to a labeling error regarding expiration dates. The recall affects the 14 Fr (4.7 mm) straight tip model, REF: RTU14F. Healthcare providers and patients must stop using the product immediately.

HANGZHOU BEVER MEDICAL DEVICES CO.
Labeling error,
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

RayStation Recalls Radiation Therapy System Over Dose Calculation Flaw

RaySearch Laboratories AB recalled its RayStation/RayPlan system on November 28, 2025. The recall affects software version RayStation 10B SP1, citing a high-risk hazard in radiation dose calculations. Affected systems may not invalidate doses as intended for certain Regions of Interest.

RAYSEARCH LABORATORIES AB
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

RaySearch Laboratories Recalling Radiation Therapy Software Due to Safety Risk

RaySearch Laboratories AB recalled 22 units of its radiation therapy treatment planning system on November 28, 2025. The recall affects software versions RayStation 11B and its updates due to a high hazard risk. The software may not invalidate calculated radiation doses correctly under certain conditions, potentially impacting patient safety.

RAYSEARCH LABORATORIES AB
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Recalls SIGMA Spectrum Infusion Pump Over Infusion Risk

Baxter Healthcare recalled 585 SIGMA Spectrum Infusion Pumps on November 28, 2025, due to a defect that may cause over-infusion. The affected model is the 35700BAX2, which has been distributed nationwide. Users must stop using the device immediately and follow recall instructions.

Baxter Healthcare
Certain pumps
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Health & Personal Care
HIGH
FDA 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
Potential for
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Health & Personal Care
HIGH
FDA 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
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

RaySearch Laboratories Recalls Radiation Therapy Software Over Dose Calculation Error

RaySearch Laboratories recalled its RayStation and RayPlan software on November 28, 2025. The software fails to invalidate calculated radiation doses for certain Regions of Interest, posing a high risk to patients. Healthcare providers must stop using the device and follow recall instructions immediately.

RAYSEARCH LABORATORIES AB
Potential for
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Recalled Outdoor Master children's helmet - model OM-TD BIKE
HIGH
CPSC

Outdoor Master OM-TD BIKE and OM-KSKB Helmets Recalled for Head Injury Risk (2025)

Outdoor Master recalled two helmet models sold and imported by Outdoor Master after a risk of serious head injury. The recall covers OM-TD BIKE and OM-KSKB helmets. The recall cites noncompliance with positional stability and coverage requirements. Stop using the recalled helmets and contact Outdoor Master for a full refund.

Outdoor Master
The recalled
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls IV Administration Kits Over Valve Malfunction Risk

Medline Industries recalled 11,173 IV administration kits on November 26, 2025. The kits contain B. Braun IV Administration Sets and Pump Administration Sets with faulty check valves. These valves may become stuck, posing a high hazard to patients.

Medline Industries, LP
Medline kits
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls IV Administration Sets Over Hazardous Check Valves

Medline Industries recalled 633 units of IV administration sets on November 26, 2025. The recall follows complaints that check valve components may become stuck, posing a high risk to patient safety. Healthcare providers and patients must stop using affected products immediately.

Medline Industries, LP
Medline kits
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Recalls 6,457 Immunoassay Analyzers Over Restart Issues

Beckman Coulter recalled 6,457 UniCel Dxl 800 analyzers on November 26, 2025, due to potential restart failures. The defect prevents the devices from transitioning to Ready mode, delaying patient sample processing. Healthcare providers must stop using the devices immediately and follow recall instructions.

Beckman Coulter
Beckman Coulter
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Health & Personal Care
HIGH
FDA DEVICE

Philips Tempus Pro Patient Monitor Recalled Over Accuracy Issues

Philips recalled 7,129 Tempus Pro Patient Monitors on November 26, 2025. The monitors may provide unvalidated measurements for Intracranial Pressure and Bladder Pressure. Incorrect readings could lead to critical clinical decisions.

Philips
Patient monitor
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Electric Homecare Beds Due to Fire Hazard

Medline Industries recalled 138,412 electric homecare beds on November 26, 2025. Hazardous hand control pendants may overheat and pose a fire risk. The recall follows 58 reports of sparking, burning, and smoking incidents.

Medline Industries, LP
Medline Industries
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Homecare Beds Over Fire Hazard Risk

Medline Industries recalled 13,245 homecare beds on November 26, 2025, due to a fire risk from the hand control pendant. The company received 58 reports of sparking, burning, and smoke. Patients and healthcare providers must stop using the beds immediately and follow recall instructions.

Medline Industries, LP
Medline Industries
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Electric Homecare Beds Due to Fire Hazard

Medline Industries recalled 15,581 electric homecare beds on November 26, 2025, due to a fire hazard. The hand control pendant may overheat, posing a risk of fire in rare cases. The recall follows 58 complaints of sparking or burning from the pendant.

Medline Industries, LP
Medline Industries
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