Drug Recalls Center

1,355 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.

1,355
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

Medline Medical Kits Recalled Due to Suction Irrigator Hazards

Medline recalled 41,432 medical procedure convenience kits on December 16, 2025. The kits contain Stryker's Strykeflow 2 Suction Irrigators that may leak or emit vaporized saline. This defect poses a high risk of injury during medical procedures.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Recalls Urology Kits Over Leak and Vapor Risks

Medline recalled 12 medical procedure kits on December 16, 2025, due to leaking issues. The kits contain Stryker's Strykeflow 2 Suction Irrigators, which can emit vaporized saline resembling smoke. Patients and healthcare providers must stop using these devices immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Vortex Surgical Recalls Laser Probes Due to Infection Risk

Vortex Surgical recalled 14,789 laser probes on December 16, 2025, due to potential bioburden contamination. The recall affects multiple catalog numbers distributed worldwide. Healthcare providers and patients must stop using these devices immediately.

Vortex Surgical
There may
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HIGHFDA DEVICE

Medline Recalls Medical Procedure Kits Due to Leakage Risk

Medline Industries recalled 12,584 medical procedure convenience kits on December 16, 2025. The recall stems from design changes in Stryker's Strykeflow 2 Suction Irrigators that can lead to leaks or vaporized saline emissions. Healthcare providers and patients must stop using the devices immediately and follow the recall instructions.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Vortex Surgical Polisher Recalled Due to Infection Risk

Vortex Surgical recalled 14,789 Tecfen Retractable Membrane Polishers on December 16, 2025. The recall stems from potential voids in Tyvek pouches that may compromise sterility and lead to bioburden contamination. Healthcare providers and patients must stop using the products immediately.

Vortex Surgical
There may
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HIGHFDA DEVICE

Vortex Surgical Recalls Injection Cannula Due to Infection Risk

Vortex Surgical recalled 14,789 units of its 25GA Subretinal Injection Cannula on December 16, 2025, due to a compromised sterile barrier. The recall affects devices distributed worldwide, including 8,651 units in the U.S. The issue may lead to bioburden contamination and potential infection.

Vortex Surgical
There may
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HIGHFDA DEVICE

Vortex Surgical Recalls Forceps and Cannula Due to Infection Risk

Vortex Surgical recalled 14,789 disposable forceps and cannula on December 16, 2025, due to potential bioburden contamination. The recall affects various models distributed worldwide, including 8,651 in the U.S. and 6,138 internationally. Users should stop using these devices immediately to prevent infection risk.

Vortex Surgical
There may
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HIGHFDA DEVICE

Vortex Surgical Recalls Disposable Elevator Over Infection Risk

Vortex Surgical recalled 14,789 Disposable Diamond Dusted ILM Elevators on December 16, 2025. The recall follows concerns about voids in the seal of Tyvek pouches, which could lead to bioburden contamination. Healthcare providers and patients should stop using the devices immediately.

Vortex Surgical
There may
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HIGHFDA DEVICE

Vortex Surgical IOL Marker Recalled Over Infection Risk

Vortex Surgical recalled 14,789 units of its Lindsell Sutured IOL Marker on December 16, 2025. The recall stems from potential voids in the seal of Tyvek pouches, risking bioburden contamination. Healthcare providers and patients must stop using the device immediately.

Vortex Surgical
There may
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HIGHFDA DEVICE

Vortex Surgical Recalls Vitrectomy Lenses Due to Infection Risk

Vortex Surgical recalled 14,789 single-use vitrectomy lenses on December 16, 2025. The recall affects models with potential seal voids that could lead to bioburden contamination. Patients and healthcare providers must stop using these devices immediately.

Vortex Surgical
There may
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HIGHFDA DEVICE

Vortex Surgical Recalls Internal Delivery Device Over Infection Risk

Vortex Surgical recalled 14,789 units of its 25GA I.D.D. Internal Delivery Device on December 16, 2025. The recall stems from potential voids in the seal of Tyvek pouches that may compromise sterility, leading to infection risks. Healthcare providers and patients are urged to stop using the device immediately and follow recall instructions.

Vortex Surgical
There may
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HIGHFDA DEVICE

Vortex Surgical Recalls Convenience Kits Over Infection Risk

Vortex Surgical recalled 14,789 convenience kits on December 16, 2025, due to potential contamination risks. Voids in the seal of Tyvek pouches may compromise sterile barriers, leading to infection. Patients and healthcare providers should stop using these kits immediately.

Vortex Surgical
There may
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HIGHFDA DEVICE

Vortex Surgical Recalls Illuminated Depressor Due to High Hazard

Vortex Surgical recalled 14,789 units of the TID Pharos Illuminated Depressor on December 16, 2025. The recall affects 8,651 units in the U.S. and 6,138 units internationally. Patients and healthcare providers should cease use immediately due to a high hazard level.

Vortex Surgical
XXX
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HIGHFDA DEVICE

Vortex Surgical Recalls 25GA Backflush Pouches Over Infection Risk

Vortex Surgical recalled 14,789 surgical backflush pouches on December 16, 2025, due to compromised sterile barriers. The recall affects catalog numbers VS0270.25 and VS0275.27, with potential for bioburden contamination. Healthcare providers and patients should stop using these devices immediately.

Vortex Surgical
There may
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HIGHFDA DEVICE

Vortex Surgical Injection Kit Recalled Over Infection Risk

Vortex Surgical recalled 14,789 I2 Injection Kits on December 16, 2025. Voids in the seal of Tyvek pouches may compromise sterility, posing an infection risk. Healthcare providers and patients must stop using this device immediately.

Vortex Surgical
There may
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HIGHFDA DEVICE

Philips Medical System Recall Over Electrical Hazard Risk

Philips Medical Systems Nederland B.V. recalled 22 Allura Xper FD10/10 systems on December 15, 2025. The recall stems from a potential electrical hazard due to an improperly installed drip tray. Patients and healthcare providers must stop using these devices immediately.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips has
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HIGHFDA DEVICE

Philips Medical Systems Recalls Allura Xper FD20 Over Electrical Hazard

Philips Medical Systems Nederland B.V. recalled two Allura Xper FD20 imaging systems on December 15, 2025. The recall follows concerns that the drip tray beneath the cooling unit may not have been properly installed. Failure to address this issue could lead to electrical short-circuits and system shutdowns.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips has
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HIGHFDA DEVICE

Philips Medical Systems Recalls Allura Xper FD10 Over Electrical Hazard

Philips Medical Systems recalled 93 Allura Xper FD10 systems on December 15, 2025, due to a potential electrical hazard. The issue arises from an improperly installed drip tray that may cause coolant to contact electrical components. This defect could lead to electrical short circuits and system shutdowns.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips has
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HIGHFDA DEVICE

ICU Medical Recalls Plum Duo Infusion System Over Speaker Failure

ICU Medical recalled 423 units of the Plum Duo Infusion System on December 15, 2025. Defective primary speakers may fail to produce audible alarms and alerts. This poses a high hazard risk to patients reliant on the device for medication administration.

ICU Medical
ICU Medical
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HIGHFDA DEVICE

ICU Medical IV Pump Recalled Due to Programming Error Risk

ICU Medical recalled its Plum Solo and Duo Infusion pumps on December 15, 2025, after reports of programming errors. The pumps can fail to flush properly after piggyback therapy, posing a serious risk to patients. Healthcare providers must stop using these devices immediately and follow recall instructions.

ICU Medical
Plum Solo
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HIGHFDA DEVICE

ICU Medical Recalls Plum Duo IV Pump Due to High Hazard

ICU Medical recalled Plum Duo Precision IV Pumps on December 15, 2025, after issues with programmed flush volumes could lead to violations. The recall affects models 400020403 in the U.S. and 400021003 in the Philippines. Users must stop using the device immediately and follow manufacturer instructions.

ICU Medical
Plum Solo
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HIGHFDA DEVICE

Sysmex America Recalls Tube Sorter Due to Lift Hazard

Sysmex America recalled 44 units of the TS-10/TS-10H Tube Sorter on December 15, 2025. The electromagnetic holding force may disengage, causing unintended movement. Healthcare providers should stop using the device immediately.

Sysmex America
Under specific
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HIGHFDA DEVICE

Philips Recalls Allura Xper FD20 OR Table Due to Electrical Hazard

Philips recalled four units of the Allura Xper FD20 OR Table on December 15, 2025, due to a potential electrical hazard. The drip tray installation issues could allow coolant to contact electrical components, risking short-circuits and system shutdowns. Healthcare providers and patients must stop using the device immediately.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips has
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