cpsc regulated Recalls

1,716 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DRUG

Alembic Pharmaceuticals Recalls Fesoterodine Tablets for Impurity Risk

Alembic Pharmaceuticals Limited recalled Fesoterodine Fumarate, Extended-release Tablets after discovering high levels of a harmful impurity. The recall affects approximately 30,000 tablets distributed nationwide. Consumers must stop using the medication immediately and consult their healthcare providers.

FESOTERODINE FUMARATE
Failed Impurities/Degradation
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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
There may
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Health & Personal Care
HIGH
FDA DRUG

SpecGx Recalls Oxycodone and Acetaminophen Tablets Over Missing Imprint

SpecGx LLC recalled 74,544 bottles of Oxycodone and Acetaminophen Tablets on December 16, 2025. The tablets may lack an imprint, raising serious identification issues. Consumers should stop using these medications immediately and contact their healthcare providers for guidance.

OXYCODONE AND ACETAMINOPHEN
Failed Tablet/Capsule
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Health & Personal Care
HIGH
FDA DRUG

SpecGx Recalls Oxycodone and Acetaminophen Tablets Due to Missing Imprint

SpecGx LLC recalled 287,988 bottles of Oxycodone and Acetaminophen tablets on December 16, 2025. The tablets may lack proper imprinting, posing risks for misuse and confusion. Healthcare providers and consumers must stop using the product immediately and seek guidance.

SpecGx LLC
Failed Tablet/Capsule
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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
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

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

Immunotech A.S. Recalls Estrone RIA Kit Over False Results Hazard

Immunotech A.S. recalled 160 Estrone RIA kits on December 15, 2025, due to a risk of falsely high patient results. This class II recall affects kits distributed in multiple countries, including the US and several European nations.

Immunotech A.S.
The affected
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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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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

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

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 Issues Recall for Allura Xper FD10/10

Philips Medical Systems recalled 21 units of the Allura Xper FD10/10 system on December 15, 2025. A defect in the drip tray could cause coolant to contact electrical components, posing a high risk of electrical short-circuits. Users should stop using the device immediately and follow recall instructions.

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

Broselow Pediatric Emergency Tape Recalled Over Dosing Errors

SunMed Holdings recalled 20,583 units of Broselow Pediatric Emergency Rainbow Tape on December 15, 2025. The product contains harmful dosing errors for critical medications including Vecuronium, Flumazenil, and Ketamine. Healthcare providers and patients must stop using the tape immediately and follow recall instructions.

SunMed Holdings
Product contains
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