Class IIOngoingZ-1630-2026
Orthalign, Inc recalls Drill Plate
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Orthalign, IncCAApr 1, 2026
Recalls: Nonconforming Material/Component
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 157–168 of 386 recalls
Class IIOngoingZ-1629-2026
Orthalign, Inc recalls Drill Plate
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Orthalign, IncCAApr 1, 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
Class IIOngoingZ-1537-2026
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-1536-2026
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-1535-2026
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-1534-2026
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