Health & Personal Care Recalls

1,814 product recalls found in this category. Browse through all safety alerts and stay informed.

High Activity Category

This category has a significant number of recalls. Please check regularly for updates.

Health & Personal Care
HIGH
FDA DEVICE

Diasol Recalls Dialysis Liquid Concentrate Over Safety Concerns

Diasol recalled 4,400 gallons of its dialysis liquid concentrate on November 5, 2025. The recall follows concerns that the safety and efficacy of the product cannot be assured. Healthcare providers and patients should stop using the product immediately.

Diasol
Safety and
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Health & Personal Care
HIGH
FDA DEVICE

Diasol Recalls Liquid Concentrate for Dialysis Due to Safety Concerns

Diasol recalled 74,400 gallons of its Liquid Concentrate for Bicarbonate Dialysis on November 5, 2025. The recall stems from concerns about the safety and efficacy of the dialysis acid concentrate. Patients and healthcare providers should stop using the product immediately.

Diasol
Safety and
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Health & Personal Care
HIGH
FDA DEVICE

Diasol Recalls Dialysis Liquid Concentrate Over Safety Concerns

Diasol recalled 186,000 containers of its liquid concentrate for bicarbonate dialysis on November 5, 2025. The company cannot assure the safety and efficacy of the product. Patients and healthcare providers should stop using it immediately and follow recall instructions.

Diasol
Safety and
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Health & Personal Care
HIGH
FDA DEVICE

Diasol Recalls Dialysis Concentrate Over Safety Concerns

Diasol recalled 7,200 gallons of its 100125-10-DEX100 liquid concentrate on November 5, 2025. The recall affects dialysis patients in multiple states due to unassured safety and efficacy. Patients and healthcare providers must stop using this product immediately.

Diasol
Safety and
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Health & Personal Care
HIGH
FDA DEVICE

Diasol Recalls Dialysis Concentrate Over Safety Concerns

Diasol recalled 4,400 gallons of its 100230-10-DEX100 dialysis acid concentrate on November 5, 2025. The company cannot assure the safety and efficacy of this product. Healthcare providers and patients must stop using the concentrate immediately.

Diasol
Safety and
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Health & Personal Care
HIGH
FDA DEVICE

Datascope Recalls Intra-Aortic Balloon Pump Due to Maintenance Risks

Datascope recalled 11,470 Intra-Aortic Balloon Pump systems on November 4, 2025. The recall addresses a revision in the Preventative Maintenance schedule as outlined in the Service Manual. Healthcare providers and patients must stop using these devices immediately.

Datascope
The IFU
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Health & Personal Care
HIGH
FDA DEVICE

Datascope Recalls Intra-Aortic Balloon Pump Over Maintenance Issues

Datascope recalled 47 units of its Cardiosave Rescue Intra-Aortic Balloon Pump on November 4, 2025. The recall addresses a revised Preventative Maintenance schedule in the device's instructions for use. This issue poses a high risk to patient safety and requires immediate attention from healthcare providers.

Datascope
The IFU
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Mycoplasma Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 23 units of its Mycoplasma test on November 3, 2025. The recall occurred due to distribution without premarket approval, classified as Class II. Patients and healthcare providers must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Allergy Test IgE Due to Approval Issues

GET TESTED INTERNATIONAL AB recalled 71 units of its Allergy Test IgE on November 3, 2025. The recall follows distribution without premarket approval, classified as Class II. Patients and healthcare providers should stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Lactose Intolerance Test

GET TESTED INTERNATIONAL AB recalled 15 units of its Lactose Intolerance Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Parasite Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 94 units of its Parasite Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients should stop using the device immediately and follow provided instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Urinary Tract Infection Test Due to Approval Issues

GET TESTED INTERNATIONAL AB recalled 40 units of its Urinary Tract Infection Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately and follow the manufacturer's instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Adrenal Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 17 units of its Adrenal Test on November 3, 2025. The recall occurred due to distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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Health & Personal Care
HIGH
FDA DEVICE

GVS TM Recalls Blood Transfusion Filter Over Sterility Concerns

GVS TM, Inc recalled 2,720 SQ40S Blood Transfusion Filters on November 3, 2025. The recall follows concerns that the sterility assurance cannot be confirmed due to incomplete quality control processes. Healthcare providers and patients must stop using the device immediately.

GVS TM
Due to
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Thyroid TSH Test Recalled Over PMA Issue (1,916 Units)

GET TESTED INTERNATIONAL AB recalled 1,916 Thyroid TSH Tests distributed nationwide in the United States. The devices were distributed without premarket approval or clearance. Healthcare providers and patients should stop using the tests and follow manufacturer instructions immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Gut Microbiome Test XL

GET TESTED INTERNATIONAL AB recalled four units of the Gut Microbiome Test XL on November 3, 2025. The recall occurred due to distribution without premarket approval. Healthcare providers and patients should stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalled Gut Microbiome Test Mega (2 Units) Over Premarket Approval Viol

GET TESTED INTERNATIONAL AB recalled 2 Gut Microbiome Test Mega units distributed nationwide in the United States. The recall centers on distribution without premarket approval or clearance. Consumers should stop using the device and contact the manufacturer for instructions. The notice was issued in 2025 and is currently active.

GET TESTED INTERNATIONAL AB
Distribution without
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB DHEA Test Recalled for Premarket-Approval Lapse, 17 Units (2025)

GET TESTED INTERNATIONAL AB recalled 17 DHEA Test devices distributed nationwide in the United States after regulators flagged distribution without premarket approval. The devices lack FDA Premarket Approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Heavy Metals Test Recall for 50 Units (2025)

GET TESTED INTERNATIONAL AB recalled 50 units of Heavy Metals Test distributed nationwide in the United States. The device was distributed without premarket FDA approval or clearance. Stop using the device immediately and contact GET TESTED INTERNATIONAL AB for instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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Health & Personal Care
HIGH
FDA DEVICE

Fresenius Kabi USA Recalls Ivenix Infusion System for Alarm Issues

Fresenius Kabi USA recalled 15,862 Ivenix Infusion Systems on November 3, 2025. The recall affects model LVP-0004 due to downstream occlusion alarms during low flow infusions. Healthcare providers and patients should stop using the device immediately.

Fresenius Kabi USA
Downstream Occlusion
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