The Recall Desk
HighFDA (Devices)·Z-0629-2013·Announced 2013-01-09

Stryker Medical Surgical Beds Recalled for Brake Ring Defect

Stryker is recalling Model 3002S3EX and 3005S3EX medical surgical beds because brake rings may not meet specifications, negatively impacting holding force.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device that affects safety (brake holding force), but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling Model 3002S3EX and Model 3005S3EX medical surgical beds. These beds were built between March 15, 2012, and May 23, 2012. The recall involves 1,004 units distributed nationwide and in Canada.

The recall is being issued because the beds may have been built with brake rings that do not meet specifications. This defect negatively impacts the holding force of the brakes. The beds are intended to support and transport patients within Med/Surg and Critical Care hospital environments.

Health care providers and hospitals should contact Stryker for instructions on how to address the defect. The source text does not specify the exact actions consumers or providers should take beyond the recall notification.

The recalled product

Product
Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model 3005 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 faci
Manufacturer
Stryker Medical Division of Stryker Corporation
Category
Medical Device — Hospital Bed
Hazard
Affected units
1,004

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model 3005S3EX
  • Serial Number 120415087 - 120515468

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Stryker Medical Division of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Stryker Medical Division of Stryker Corporation

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Same hazard · brake defect

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