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FDA Medical Device Recalls (openFDA)

Stryker Medical Div. of Stryker Corporation: Stryker Zoom critical care bed, 115v, Stryker Medical, Portage, MI; Model 2040. Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.

Recall number
Z-2215-2009
Recalling firm
Stryker Medical Div. of Stryker Corporation
Product
Stryker Zoom critical care bed, 115v, Stryker Medical, Portage, MI; Model 2040. Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.
Status
Terminated
Initiated
2009-08-10
Posted
2009-09-18
Terminated
2011-04-25
Reason
The backrest of the bed may not stay in an upright position (may drift down when left raised).
Root cause
Device Design
Action
Stryker Medical issued an "Urgent - Medical Device Correction" letter dated August 10, 2009 informing customers to locate the affected product listed and verify whether it is functioning properly. In the case the device is not properly functioning, remove from service and contact the firm as soon as possible at 1-800-STRYKER, option 3. Customers are also asked to return an enclosed return receipt post card and also forward the notification to users who have loaned or purchased the device. A representative from Stryker field service will be contacting you to perform device corrections shortly. For further information, contact Stryker Medical at 1-269-324-6527.
Quantity
12,599 total products
Distribution
Worldwide Distribution -- United States, Brazil, Canada, Chile, China, India, Korea, Latin America, Mexico, Singapore and Switzerland.
Lot, serial or model codes
Serial Numbers: 0801098611, 0801098612, 0801098613, 0801098614, 0801098615, 0801098616, 0801098617, 0801098618, 0801098619, 0801098620, 0801098621, 0801098622, 0801098623, 0801098624, 0801098625, 0801098677, 0801098678, 0801098679, 0801098680, 0801098681, 0801098682, 0801098683, 0801098684, 0801098685, 0801098686, 0801098687, 0801098688, 0801098689, 0801098690, 0801098691, 0801098692, 0801098693, 0801098694, 0801098695, 0801098696, 0801098697, 0801098698, 0801098699, 0801098700, 0801098701, 0801098702, 0801098703, 0801098704, 0801098705, 0801098706, 0801098731, 0801098732, 0801098781, 0801098782, 0802102002, 0802102003, 0802102004, 0802102005, 0802102006, 0802102007, 0802102008, 0802102009, 0802102010, 0802102011, 0802102012, 0802102013, 0802102014, 0802102015, 0802102016, 0802102028, 0802102029, 0802102030, 0802102031, 0802102032, 0802102033, 0802102034, 0802102035, 0802102036, 0802102037, 0802102038, 0802102039, 0802102040, 0802102041, 0802102042, 0802102043, 0802102044, 0802102045, 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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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