Agency classClass IIOur severity:Severe FDA (Devices)·Z-0628-2013·Announced 2013-01-09

Stryker Medical Surgical Beds Recalled for Brake Ring Defect

Stryker is recalling 9 Model 3002SEX and 3005S3EX medical surgical beds because brake rings may not meet specifications, negatively impacting holding force.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device (brake holding force) that poses a significant risk of injury to patients, meeting the criteria for a Severe rating.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling 9 units of Model 3002SEX and Model 3005S3EX Medical Surgical Beds. These beds are intended to support and transport patients in Med/Surg and Critical Care hospital environments, including pre-op, post-op, and recovery areas.

The recall is due to a defect where the affected beds may have been built with brake rings that do not meet specifications. This issue negatively impacts the holding force of the brakes. The affected units were built between March 15, 2012, and May 23, 2012, and were distributed nationwide and in Canada.

Healthcare facilities should identify affected units by checking for Model 3002SEX or 3005S3EX with serial numbers ranging from 120315371 to 120315379. Users should contact Stryker for instructions on how to proceed with the recall.

The recalled product

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…
Manufacturer: Stryker Medical Division of Stryker Corporation
Category: Medical Device — Hospital Bed
Hazard: structural-defect
fall-risk
Affected units: 9

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 3002SEX
Serial Number 120315371-120315379

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 →

Same manufacturer · Stryker Medical Division of Stryker Corporation

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