An FDA-recorded root-cause determination. The FDA lists 23 recalls with this root cause since 2025, 1 of them Class I (most serious). Most recent report: May 13, 2026.
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"
Surgical light assembly may not adequate support the weight of the ceiling cover.
Due to pediatric defibrillator electrode delamination
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising;…
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at…
Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit.
Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
Preset treatment parameters are not consistently being used in accordance with the IFU.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.