All Product Recalls

Browse through 2,317 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

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
Read more
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
Read more
HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Medical Device Recalled for Illegal Marketing

GET TESTED INTERNATIONAL AB recalled one medical device on November 3, 2025, due to distribution without premarket approval. The recall affects the entire lot and requires immediate cessation of use. Patients and healthcare providers must follow the manufacturer’s instructions for safe disposal or return of the product.

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

GET TESTED INTERNATIONAL AB Recalls Vitamin D2 and D3 Test

GET TESTED INTERNATIONAL AB recalled 10 units of its Vitamin D2 and D3 Test on November 3, 2025. The recall follows distribution without premarket approval. Patients and healthcare providers must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Drug Test Over Approval Issue

GET TESTED INTERNATIONAL AB recalled one unit of its Drug Test Small on November 3, 2025. The recall occurred due to distribution without premarket approval or clearance. The FDA classified this recall as Class II, indicating a high risk to patients and healthcare providers.

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

GET TESTED INTERNATIONAL AB Recalls Serotonin Test for Safety Risk

GET TESTED INTERNATIONAL AB recalled 12 units of the Serotonin Test on November 3, 2025. The recall occurred due to distribution without premarket approval. Patients and healthcare providers must stop using the device immediately.

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

GET TESTED INTERNATIONAL AB Recalls DHEA Test Due to Approval Issues

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

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Advertisement