Stryker S3 Med/Surg Bed Recall for Foot End Cover Damage
Stryker is recalling S3 Med/Surg beds due to potential damage to the Foot End Cover and Power Coil Cable caused by reduced clearance.
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 3/5 (High).
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 is classified as FDA Class II, and the hazard involves potential mechanical damage to a medical device used in hospital settings, which poses a risk of harm without reported injuries.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling S3 Med/Surg Bed Secure II and 3002 S3 models. The recall affects beds built between April 2, 2005, and July 26, 2011.
The recall is due to a potential issue where reduced clearance between the Foot End Cover and Foot End Lift Header can cause damage to the Foot End Cover and/or Power Coil Cable. The affected beds are typically found in Med-Surg units of hospitals.
The recall covers 108,769 units distributed worldwide, including the United States, Canada, and various international locations. Stryker has identified the specific serial numbers and models involved in this recall.
The recalled product
- Product
- S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual…
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Category
- Medical Device — Hospital Bed
- Affected units
- 108,769
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 (20)
- Models: 3002 S3 EX
- 3002 S3 PATRIOT
- 3002 S3 CUSTOM
- 3002 S3 ZOOM
- and 3002 S3 SIGNATURE. And Serial Numbers:080615942
- 080715062
- 080916706
- 080916707
- 080916708
- 080916709
- 080916710
- 080916711
- 080916712
- 080916713
- 080916714
- 080916715
- 080916716
- 080916717
- 090415690
- 100215206
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.
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