Stryker Medical Div. of Stryker Corporation: Stryker Epic II critical care bed, 230v, Stryker Medical, Portage, MI; Model 2031. (Note: This product is not sold in the US). Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.

Recall number

Z-2214-2009

Recalling firm

Stryker Medical Div. of Stryker Corporation

Product

Stryker Epic II critical care bed, 230v, Stryker Medical, Portage, MI; Model 2031. (Note: This product is not sold in the US). 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 of all products

Distribution

Worldwide Distribution -- United States, Brazil, Canada, Chile, China, India, Korea, Latin America, Mexico, Singapore and Switzerland.

Lot, serial or model codes

Note these serial numbers are inclusive for models 2030 and 2031. 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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

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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