Stryker S3 MedSurg Bed Fowler Control Failure Recall
Stryker is recalling S3 MedSurg Beds because CPU board failures can cause the backrest electronic controls to stop working.
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 a functional failure of a medical device that could impact patient care, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling 8,490 units of the S3 MedSurg Bed, Model 3005. The recall covers specific model codes including 3005S3EX, 3005S3Patriot, 3005S3Signature, and various 3005S3PX series, with serial numbers ranging from 141115067 through 150615027.
The recall is due to CPU board failures that cause the fowler (backrest) electronic controls to stop working. This defect may prevent the bed from adjusting the backrest as intended.
The affected beds were distributed in the United States, Canada, and Mexico. Healthcare facilities should contact Stryker for instructions on how to address the defect.
The recalled product
- Product
- S3 MedSurg Bed, Model 3005. Stryker Medical
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Category
- Medical Device — Hospital Bed
- Affected units
- 8,490
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 (9)
- MDL#: E341062
- 3005S3EX
- 3005S3Patriot
- 3005S3Signature
- 3005S3PX1
- 3005S3PX2
- 3005S3PX3
- 3005S3PX4
- Serial Numbers: 141115067 through 150615027
Distribution
Distributed nationwide across the United States.
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