FDAApril 8, 2022device
XVIVO Organ Chamber REF 19020
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
What to do
FDA enforcement status: Terminated
Brands named
xvivo perfusion abxvivoxvivo perfusion
UPCs
07350069520074
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOctopus Evolution Tissue Stabilizer, Model TS20002026-05-12
- FDAOctopus 4 Tissue Stabilizer, Model 294002026-05-12
- FDAOctopus Evolution AS Tissue Stabilizer, Model TS25002026-05-12
- FDAMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter2026-04-21
- FDAMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter2026-04-21
- FDAMedtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter2026-04-21
- FDAMedtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter2026-04-21
- FDAMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter2026-04-21
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