Diagnostics and lab testing: FDA Approvals, Recalls, 510(k)…

744device recalls (since 1 Jan 2023)
189510(k) clearances (since 1 Jan 2023)

Each number has its full source under its own list below.

Device recalls

744 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

24Sep2026
System, Imaging, Pulsed Doppler, Ultrasonic
Reason: Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital (ambul…
Z-0152-2027
14Sep2026
System, Multipurpose For In Vitro Coagulation Studies
Reason: Microcoagulation test used to evaluate low dose heparin anticoagulation has a mispositioned or absent clot activating reagent, which may result in out-of-range high error code, or erroneously high re…
Z-0317-2027
3Sep2026
Platelet Factor 4 Radioimmunoassay
Reason: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Z-0001-2027
3Sep2026
Platelet Factor 4 Radioimmunoassay
Reason: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Z-0002-2027
2Sep2026
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason: Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different fro…
Z-0083-2027
2Sep2026
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason: Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different f…
Z-0084-2027
24Aug2026
Catheter, Intravascular, Diagnostic
Reason: Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
Z-3214-2026
20Aug2026
Visual, Pregnancy Hcg, Prescription Use
Reason: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Z-3271-2026
18Aug2026
Catheter, Recording, Electrode, Reprocessed
Reason: Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombu…
Z-0085-2027
18Aug2026
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason: In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing…
Z-0190-2027