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This category has a significant number of recalls. Check it regularly if you own products in this area.
GET TESTED INTERNATIONAL AB's SIBO Test was distributed nationwide in the United States. The device was distributed without FDA premarket approval or clearance. Stop using the device immediately and follow the recall instructions from the manufacturer.
GET TESTED INTERNATIONAL AB recalled 109 units of its Candida Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers should stop using this device immediately.
Distribution without premarket approval/clearance.
Orthofix U.S. recalled 40,956 units of the CONSTRUX Mini Ti Spacer System on November 3, 2025. Labeling inconsistencies pose potential risks to patients and healthcare providers. Users should stop using the device immediately and follow recall instructions.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB recalled 10 units of the Pollen Allergy Test on November 3, 2025. The recall stems from distribution without necessary premarket approval. Patients should stop using the device immediately and follow manufacturer instructions.
Labeling contains claims that are not consistently present.
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 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 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.
A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
Potential issue where the IntelliVue monitors did not alarm.
Potential issue where the IntelliVue monitors did not alarm.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America recalled 1,913,441 IntelliVue MP90 monitors on October 31, 2025. The monitors may fail to alarm, posing a high risk to patient safety. Users must stop using the devices immediately and follow manufacturer instructions for remedy.
Philips North America is recalling 1,913,441 IntelliVue MP2 patient monitors worldwide. The devices may fail to alarm when critical conditions arise. Hospitals should stop using the monitors and follow Philips recall instructions.