cpsc regulated Recalls

2,056 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Broselow Recall: Harmful Dosing Errors in Pediatric Organizer

Broselow recalled 89 units of the BROSELOW FILLED BROSELOW ORGANIZER on December 15, 2025. The product contains harmful dosing errors for critical medications. Healthcare providers must stop using the device immediately.

SunMed Holdings
Product contains
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical Recalls da Vinci SP Access Port Kits Over Sterility Risk

Intuitive Surgical recalled 41,526 da Vinci SP Access Port Kits on December 15, 2025, due to potential cracks in the tray that could breach sterility. The recall affects models 430073 and 430075, distributed worldwide including across the US and various countries. Patients and healthcare providers must stop using these devices immediately and follow manufacturer instructions for return.

Intuitive Surgical
Access Port
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Health & Personal Care
HIGH
FDA DRUG

Novadoz Pharmaceuticals Recalls Glycopyrrolate Oral Solution Over Safety Concerns

Novadoz Pharmaceuticals LLC recalled Glycopyrrolate Oral Solution on December 15, 2025, due to failed impurities and degradation specifications. The recall affects Rx only products manufactured by MSN Pharmaceuticals Inc. Consumers should stop using this medication immediately.

GLYCOPYRROLATE
Failed Impurities/Degradation
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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

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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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 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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Health & Personal Care
HIGH
FDA DEVICE

Hologic Recalls Brevera Breast Biopsy System Due to Contamination Hazard

Hologic, Inc. recalled 681,870 units of the Brevera Breast Biopsy System on December 15, 2025, due to presence of particulates that can enter breast tissue. The recall affects devices distributed nationwide in the U.S. Healthcare providers and patients must stop using the device immediately.

Hologic
Presence of
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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

Philips Medical Device Recalled Due to Electrical Hazard

Philips recalled 95 Allura Xper FD10 systems on December 15, 2025. The recall resulted from missing or improperly documented installation of the drip tray, posing an electrical hazard. Users should stop using the device immediately and follow the manufacturer’s instructions.

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

SunMed Recalls Broselow Pediatric Emergency Tape Over Dosing Errors

SunMed Holdings recalled 95,300 units of Broselow Pediatric Emergency Rainbow Tape on December 15, 2025. The tape contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Patients and healthcare providers must stop using the product immediately.

SunMed Holdings
Product contains
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Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Imaging System Recalled Over Electrical Hazard

Philips recalled 14 units of the Allura Xper FD10/10 due to a potential electrical hazard. The recall affects medical imaging systems distributed worldwide. If the drip tray beneath the cooling unit is not installed, coolant may contact electrical components, leading to system shutdown.

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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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 FD10F Systems Due to Electrical Hazard

Philips Medical Systems recalled 12 Allura Xper FD10F systems on December 15, 2025, after identifying a potential electrical hazard. The drip tray beneath the cooling unit may not have been installed correctly, posing a risk of coolant leakage and electrical short-circuits. Users must 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

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

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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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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