FDA DeviceClass IINotable
FDA Recall: On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Description
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Hazard
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Remedy
10
Related Recalls
2026-08-12 · FDA_DEVICE
FDA Recall: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Siemens Healthcare Diagnostics, Inc.
2026-08-12 · FDA_DEVICE
FDA Recall: FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing
INTEGRATED MEDCRAFT LLC
2026-08-12 · FDA_DEVICE
FDA Recall: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Siemens Healthcare Diagnostics, Inc.
2026-08-12 · FDA_DEVICE
FDA Recall: GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
GE Medical Systems Information Technologies Inc