Stryker SelectCore Biopsy Device Recalled for Stylet Ejection Risk
Stryker is recalling 55 units of the SelectCore Variable Throw Biopsy Device because the stylet may eject during use.
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 medical device with a mechanical defect that poses a risk of harm during use, but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is recalling 55 units of the Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM. The recall is due to the potential for the stylet to eject from the device during actuation.
The affected devices are sterile, single-use instruments used to obtain biopsy samples from soft tissues such as the liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. The specific product details are Model Number 0904-410-000 and Lot Number 61406001.
The devices were distributed nationwide in the United States, specifically in the states of Texas, New Jersey, and Mississippi. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for this recall.
The recalled product
- Product
- Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors.…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Biopsy Device
- Affected units
- 55
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)
- Stryker Model Number: 0904-410-000
- Lot# 61406001
Distribution
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