Z-0628-2013Class II

Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and...

Name: Z-0628-2013 Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and...
Creator: Stryker Medical Division of Stryker Corporation
Published: 2012-12-18
License: https://open.fda.gov/license/

Stryker Medical / initiated 2012-12-18 / Terminated / root cause: manufacturing process

FDA source

Stryker Medical Division of Stryker Corporation began a recall of 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... on 2012-12-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0628-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-18
Posted: 2013-01-03
Terminated: 2013-08-30
Recalling firm: Stryker Medical
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
Product code: FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 9
Distribution: Worldwide Distribution - Nationwide and Canada
Product codes and lots: Model 3002SEX, Serial Number 120315371-120315379

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0628-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0628-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-09	2013-01-03
Z-0629-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-09	2013-01-03

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)