Class IIOngoingZ-1549-2026
Medartis AG recalls Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Medartis AGMar 18, 2026
2026 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,537–1,548 of 2,088 recalls
Class IOngoingZ-1548-2026
Trividia Health, Inc. recalls Owner's Booklets and Instructions for Use that are used with the following blood glucos…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
Trividia Health, Inc.FLMar 18, 2026
Class IOngoingZ-1547-2026
Trividia Health, Inc. recalls Owner's Booklets and Instructions for Use that are used with the following blood glucos…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
Trividia Health, Inc.FLMar 18, 2026
Class IOngoingZ-1546-2026
Trividia Health, Inc. recalls Owner's Booklets and Instructions for Use that are used with the following blood glucos…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
Trividia Health, Inc.FLMar 18, 2026
Class IOngoingZ-1545-2026
Trividia Health, Inc. recalls Owner's Booklets and Instructions for Use that are used with the following blood glucos…
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…
Trividia Health, Inc.FLMar 18, 2026
Class IIOngoingZ-1544-2026
Physio-Control, Inc. recalls PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 1…
Due to pediatric defibrillator electrode delamination
Physio-Control, Inc.WAMar 18, 2026
Class IIOngoingZ-1543-2026
Instrumentation Laboratory recalls GEM Premier 5000
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including conse…
Instrumentation Labora…MAMar 18, 2026
Class IIOngoingZ-1542-2026
Instrumentation Laboratory recalls GEM Premier 5000
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including conse…
Instrumentation Labora…MAMar 18, 2026
Class IIOngoingZ-1541-2026
Instrumentation Laboratory recalls GEM Premier 5000
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including conse…
Instrumentation Labora…MAMar 18, 2026
Class IIOngoingZ-1540-2026
Instrumentation Laboratory recalls GEM Premier 5000
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including conse…
Instrumentation Labora…MAMar 18, 2026
Class IIOngoingZ-1539-2026
Instrumentation Laboratory recalls GEM Premier 5000
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including conse…
Instrumentation Labora…MAMar 18, 2026
Class IIOngoingZ-1538-2026
Instrumentation Laboratory recalls GEM Premier 5000
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including conse…
Instrumentation Labora…MAMar 18, 2026