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FDA Medical Device Recalls (openFDA)

Respironics California Inc: Esprit Ventilator.

Recall number
Z-0722-04
Recalling firm
Respironics California Inc
Product
Esprit Ventilator.
Status
Terminated
Initiated
2003-07-14
Posted
2004-07-20
Terminated
2004-03-17
Reason
Valves may stick in the closed position due to manufacturing error.
Root cause
Other
Action
Uninstalled ventilators were returned for change of the inhalation module. Otherwise, service technicians replaced the module in the field. Recall is complete.
Quantity
20
Distribution
OH, NY, NJ, PA, CO, IL, MI, NC, GA. England.
Lot, serial or model codes
Serial numbers: VS300430, VS3004361, VS3004335, VS3004301, VS3004327, VS3004353, VS3004377, VS3004366, VS3004328, VS3004337, VS3004357, VS3004385, VS3004369, VS3004295, VS3004310, VS3004292, VS3004305, VS3004381, VS3004296, VS3004299.
510(k) numbers
not on file
PMA numbers
not on file
Product code
CBK
Firm FEI
2518422
Firm city
Carlsbad
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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