cpsc regulated Recalls

2,143 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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
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Health & Personal Care
HIGH
FDA 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
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

LEASEIR Surgical Laser Recalled Over Missing Danger Label

LEASEIR recalled two MHR Xcell surgical laser devices on December 15, 2025. The console label for affected devices lacks a "DANGER" symbol, posing a high hazard risk. Healthcare providers and patients must stop using the device immediately and follow recall instructions.

LEASEIR TECHNOLOGIES SLU
The console
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Health & Personal Care
HIGH
FDA DEVICE

Philips Recalls Allura Xper FD20 Biplane Over Electrical Hazard

Philips recalled 18 Allura Xper FD20 Biplane systems on December 15, 2025, due to an electrical hazard. The drip tray beneath the cooling unit may not have been installed, risking coolant contact with electrical components. This issue could cause electrical short circuits and system shutdowns.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips has
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Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Systems Recalling Allura Xper FD10 Over Electrical Risk

Philips Medical Systems Nederland B.V. recalled 56 Allura Xper FD10 systems on December 15, 2025. The recall stems from a potential electrical hazard where coolant may contact electrical components, risking short-circuits. Healthcare providers must cease use immediately and follow provided instructions.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips has
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Health & Personal Care
HIGH
FDA DEVICE

Broselow Recall Due to Dangerous Dosing Errors in ALS Organizer

Broselow recalled 384 units of their Domestic Complete ALS Organizer on December 15, 2025, due to harmful dosing errors. The recalled product affects dosages for Vecuronium, Flumazenil, and Ketamine. Healthcare providers and patients must stop using the device immediately.

SunMed Holdings
Product contains
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Health & Personal Care
HIGH
FDA 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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