Stryker Secure II Med/Surg Beds Recalled for Potential Cover Damage
Stryker is recalling Secure II and 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 defect involves a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported incidents.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling Secure II and S3 Med/Surg beds manufactured between April 2, 2005, and July 26, 2011. The recall involves 108,769 units distributed worldwide, including the United States, Canada, and various international markets.
The recall is due to a potential issue where reduced clearance between the Foot End Cover and the Foot End Lift Header may cause damage to the Foot End Cover and/or the Power Coil Cable. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Hospitals and medical facilities should identify affected units by checking the model numbers (3002 EX, 3002 KCI, 3002 CUSTOM, 3002 ZOOM, 3002000000, and 3002 ZX-SB) and the specific serial numbers listed in the official recall notice. Users should contact Stryker Medical for instructions on how to address the potential damage.
The recalled product
- Product
- Secure II 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…
- 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 EX
- 3002 KCI
- 3002 CUSTOM
- 3002 ZOOM
- 3002000000
- and 3002 ZX-SB. And Serial Numbers: 060215711
- 060215712
- 060215713
- 060215714
- 060215715
- 060215716
- 060215717
- 060215718
- 060215719
- 060215720
- 060215721
- 060215722
- 060215723
- 060215724
- 060215725
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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