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FDA Medical Device Recalls (openFDA)

Stryker Medical Division of Stryker Corporation: Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls

Recall number
Z-0628-2013
Recalling firm
Stryker Medical Division of Stryker Corporation
Product
Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls
Status
Terminated
Initiated
2012-12-18
Posted
2013-01-03
Terminated
2013-08-30
Reason
Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. The affected beds may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes.
Root cause
Process control
Action
Stryker sent an Urgent Medical Device Correction letterdated December 18, 2012, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate the affected product and ensure that the brakes are holding properly. Consignees were directed to contact Stryker (1-800-327-0770, option 2) to make arrangements to replace all brake rings and continue to routinely inspect brake functionality. Customers were asked to Fax (269-488-8691) the enclosed acknowledgment and Stryker field service will contact customers to schedule service. Consignees were directed to forward a copy of this notice to the new users and advise us of their new location. For questions regarding this recall call 269-488-8691.
Quantity
9
Distribution
Worldwide Distribution - Nationwide and Canada
Lot, serial or model codes
Model 3002SEX, Serial Number 120315371-120315379
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

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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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