CLASS II Device recall · Reported 8 Jun 2022 · FDA Enforcement Report
Xvivo Organ Chamber recalled by Xvivo Perfusion Ab
Xvivo Perfusion Ab is recalling Xvivo Organ Chamber, distributed in 8 states. The recall was initiated on 8 Apr 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1212-2022
- FDA event ID
- 90143
- Recalling firm
- Xvivo Perfusion Ab, Goteborg, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Apr 2022
- FDA classified
- 1 Jun 2022
- Reported
- 8 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 8 Apr 2022 | Recall initiated by company | |
| 1 Jun 2022 | Classified by FDA | +54 days |
| 8 Jun 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
XVIVO Organ Chamber REF 19020
Where it was distributed
U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland
CaliforniaFloridaMassachusettsNorth CarolinaNew YorkOhioPennsylvaniaTexas
Questions about this recall
Why was it recalled?
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Which lots are affected?
Model Number: 19020 Lot Numbers/UDI Codes: LOT: 13801, UDI: (01)07350069520074(17)240930(10)13801 LOT: 13802, UDI: (01)07350069520074(17)240930(10)13802 LOT: 13803, UDI: (01)07350069520074(17)240930(10)13803 LOT: 13804, UDI: (01)07350069520074(17)240930(10)13804 LOT: 13805, UDI: (01)07350069520074(17)240930(10)13805 LOT: 13806, UDI: (01)07350069520074(17)240930(10)13806
Where was it sold?
U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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