Stryker Connected OR Cart Recalled Due to Monitor Attachment Defect
Stryker is recalling 12 Connected OR Carts because the monitor may not attach correctly, posing a risk of the monitor falling and injuring users.
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 involves a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria for potential physical injury from a falling component.
Plain-English summary
Stryker Corporation is recalling 12 units of the Stryker Connected OR Cart, 120 V (Ref Cat. #240-099-155). The recall is due to a manufacturing defect where the cart monitor does not attach flush with the monitor stow handle. The product is not manufactured to specifications and is positioned on the incorrect side.
This defect may lead to the monitor falling from the monitor arm, creating a risk of user injury. The affected devices were distributed worldwide, including in the US states of Georgia and Texas, and in Canada, Singapore, Thailand, and Malaysia.
Healthcare facilities should stop using the affected carts and contact Stryker Corporation for instructions on how to resolve the issue. The recall number is Z-1445-2020.
The recalled product
- Product
- Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court, San Jose, CA 95138, UDI: 07613327462784 - Product Usage: The Connect OR Cart is a mobile, medical-grade cart intended to store and transport components of…
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Surgical Cart
- Affected units
- 12
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 (12)
- UDI: 07613327462784 Lot Numbers: 2019AN00005
- 2019AN 00007
- 2019AN00017
- 2019AN00039
- 2019AN00041
- 2019AN00046
- 2019AN00048
- 2019AN00054
- 2019AN00061
- 2019AN00067
- 2019AN00085
- 2019AN00087
Distribution
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