All Product Recalls

Browse through 1,551 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Issues Gonorrhea Test Recall

GET TESTED INTERNATIONAL AB recalled 463 gonorrhea tests on November 3, 2025. The recall follows 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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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls MPOX Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled four MPOX Test units on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Healthcare providers and patients must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls D-Dimer Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 1,218 D-Dimer Tests on November 3, 2025, due to distribution without premarket approval. The recall affects units distributed nationwide in the U.S. Patients and healthcare providers must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Fructose Intolerance Test

GET TESTED INTERNATIONAL AB recalled eight units of the Fructose Intolerance Test on November 3, 2025. The recall occurs due to distribution without premarket approval. Patients and healthcare providers should stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Vitamin D-Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 1,557 Vitamin D-Tests on November 3, 2025, due to distribution without premarket approval. The recall affects devices distributed nationwide in the United States. Consumers should stop using the test immediately and follow manufacturer instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalled GI Microbiome Profile XL

GET TESTED INTERNATIONAL AB recalled the GI Microbiome Profile XL on November 3, 2025, due to distribution without premarket approval. Three units were distributed nationwide in the U.S. Patients and healthcare providers should stop using this device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA 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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HIGHFDA 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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HIGHFDA 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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HIGHFDA 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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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls PSA Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 27 units of the PSA Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers must stop using the test immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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