immediate action Recalls

Fresenius Kabi USA Recalls 483 LVP Infusion Sets for IVENIX System Over Incorrect Assembly (2025)

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

GET TESTED INTERNATIONAL AB Candida Test Recalled for 166 Units in 2025

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Recalls 3 Food Sensitivity Test Small Units in 2025

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL Gut Microbiome Test Large Recalled for Premarket-Approval Violation (2025)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Issues Recall for Pet Allergy Test

GET TESTED INTERNATIONAL AB recalled 29 Pet Allergy Test units 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 Issues Recall of Alcohol Test Kit

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Issues Recall for HPV Antigen Test

GET TESTED INTERNATIONAL AB recalled 258 HPV Antigen Tests on November 3, 2025. The tests were distributed nationwide without premarket approval or clearance. Healthcare providers and patients must stop using these devices immediately.

Orthofix Recalls PTC Spacer Systems Over Labeling Issues

Labeling contains claims that are not consistently present.

Orthofix Recalls FIREBIRD SI Fusion System Over Labeling Issues

Orthofix U.S. recalled 19,431 units of its FIREBIRD SI Fusion System on November 3, 2025. The recall stems from inconsistent labeling claims that may mislead users. Affected models include multiple sizes of FIREBIRD SI Screws, sold worldwide.

GET TESTED INTERNATIONAL AB Parasite Test Recalled for Distribution Without Premarket Approval

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB MPOX Test Recall for 4 Units Distributed in US (2025)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Recalls Sperm Test Due to Approval Issues

GET TESTED INTERNATIONAL AB recalled 33 units of its sperm 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 Thyroid TSH Test Recalled Over PMA Issue (1,916 Units)

Distribution without premarket approval/clearance.

Nissan Recalls 2025 Sentra for Driver Seat Frame Security Issue

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 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 PSA Test Recall 27 Units Distributed Nationwide 2025

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Medical Device Recalled for Illegal Marketing

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Recalls Organic Acids Test

GET TESTED INTERNATIONAL AB recalled one unit of its Organic Acids Profile Test Large on November 3, 2025. The recall occurred due to distribution without necessary premarket approval. Patients and healthcare providers should stop using the device immediately.

GET TESTED INTERNATIONAL AB Biological Age & Longevity Test Recalled for Premarket Issue (3 Units,

Distribution without premarket approval/clearance.