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FDA Medical Device Recalls (openFDA)

Stryker Medical Div. of Stryker Corporation: Stryker Medical Epic II Critical Care Bed, 115 V, Stryker Medical, Portage, MI.; Model 2030.

Recall number
Z-1686-2008
Recalling firm
Stryker Medical Div. of Stryker Corporation
Product
Stryker Medical Epic II Critical Care Bed, 115 V, Stryker Medical, Portage, MI.; Model 2030.
Status
Terminated
Initiated
2008-02-01
Posted
2008-09-19
Terminated
2010-11-05
Reason
The brakes may not have adequate holding power to lock the bed in place.
Root cause
Device Design
Action
Consignees were notified via letter dated 2/1/08 and informed that upgrade kits along with full written and video installation instructions will be sent to correct the problem.
Quantity
66,558 of all models.
Distribution
Worldwide, Argentina, Brazil, Canada, Chile, China, Greece, India Japan, Mexico, Poland, Singapore, South Africa, South Korea, Switzerland, Taiwan and United Kingdom.
Lot, serial or model codes
Serial numbers 0409060501 through 0711096119.
510(k) numbers
not on file
PMA numbers
not on file
Product code
FNL
Firm FEI
1831750
Firm city
Portage
Firm state
MI
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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