cpsc regulated Recalls

2,143 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Vortex Surgical Recalls Convenience Kits Over Infection Risk

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

Vortex Surgical
There may
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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 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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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
There may
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Health & Personal Care
HIGH
FDA DEVICE

ICU Medical Recalls Plum Duo Infusion Pump Over High Hazard Risk

ICU Medical recalled the Plum Duo Infusion Pump on December 15, 2025, after reports of malfunctioning flush programming. The recall affects models 400020401 and 400021001 sold worldwide. This issue may pose a high risk to patient safety.

ICU Medical
Plum Solo
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Health & Personal Care
HIGH
FDA DEVICE

Philips Recalls Allura Xper FD20 Over Electrical Hazard

Philips recalled 79 Allura Xper FD20 systems on December 15, 2025. The recall affects systems with an improperly installed drip tray which can cause electrical short-circuits. Healthcare providers and patients must stop using the device immediately.

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