Drug Recalls Center

1,425 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.

1,425
Total Drug Recalls
24
High Risk Medications
FDA
Official Source

Important Medication Safety Information

  • Do not stop taking prescribed medications without consulting your healthcare provider
  • Contact your pharmacist or doctor if you have a recalled medication
  • Check lot numbers carefully - not all batches may be affected
  • Return recalled medications to your pharmacy for proper disposal

Looking for a specific drug? Use the search page to find recalls by medication name, manufacturer, or NDC number.

HIGHFDA 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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HIGHFDA 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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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
Potential for
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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
Potential for
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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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HIGHFDA DEVICE

Medline Recalls Homecare Beds Over Fire Hazard

Medline Industries recalled 22,565 Full Electric Low Basic Homecare Beds on November 26, 2025, due to a fire risk. The recall affects beds labeled with REF MDR107003ELO following 58 reports of overheating hand control pendants. Consumers should stop using the beds and follow recall instructions immediately.

Medline Industries, LP
Medline Industries
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HIGHFDA DEVICE

Medline Recalls Homecare Beds Over Fire Hazard Risk

Medline Industries recalled 373,392 homecare beds on November 26, 2025, due to a fire hazard. The hand control pendant can overheat, causing sparking or burning. The recall affects models MDR107002E and MDR107002E-4 sold in the U.S. and Canada.

Medline Industries, LP
Medline Industries
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HIGHFDA DEVICE

Cook Medical Recalls Introducer Sheaths Over Manufacturing Errors

Cook Medical recalled 7,952 Flexor Check-Flo introducers and sets on November 26, 2025. The devices may have been manufactured out of specification, potentially posing serious risks to patients. Health care providers and patients should stop using these products immediately.

Cook
Cook Medical
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HIGHFDA DEVICE

Cook Medical Recalls Transjugular Liver Access Set Over Hazardous Manufacturing

Cook Medical recalled 23 units of its Transjugular Liver Access Sets on November 26, 2025. The recall follows concerns that products may have been manufactured out of specification, leading to potential use errors. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

Cook
Cook Medical
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HIGHFDA DEVICE

Medline Recalls IV Administration Sets Due to Valve Malfunction

Medline Industries recalled 12 IV administration kits on November 26, 2025. The kits may contain defective check valve components that can become stuck. Patients and healthcare providers should stop using these devices immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Recalls IV Administration Sets Over Valve Malfunction Risk

Medline Industries recalled 96 IV administration sets on November 26, 2025, due to a defect in the check valve. The defect can cause the valves to become stuck, posing a high risk for patients. Users should stop using the products immediately and follow the recall instructions.

Medline Industries, LP
Medline kits
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HIGHFDA 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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HIGHFDA 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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HIGHFDA DEVICE

Medline Recalls IV Administration Sets Due to Valve Issues

Medline Industries recalled 3,045 IV administration kits on November 26, 2025. The recall affects several Medline kits due to potential malfunction of check valve components. Patients and healthcare providers should stop using these devices immediately.

Medline Industries, LP
Medline kits
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