Boston Scientific JAGTOME RX Medical Device Recalled for Sterile Barrier Breach
Boston Scientific is recalling 101 units of JAGTOME RX devices due to compromised sterile barriers that could allow contamination and infection. The recall affects devices distributed worldwide.
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: FDA Class II recall where the sterile barrier is compromised, creating infection risk. No illnesses or injuries have been reported, meeting the criteria for High severity as a risk-of-harm product without reported injury.
Plain-English summary
Boston Scientific Corporation is recalling 101 units of the JAGTOME RX 49-20-260-035 medical device (Material Number M00573000) across lot numbers 27690967, 27949032, 27604634, and 27692921.
The sterile barrier of the device is compromised, which creates a risk that the device may become contaminated with bacteria or other pathogens, potentially leading to infection in patients who receive the device.
The affected devices have been distributed worldwide, including throughout the United States and in numerous countries including Australia, Canada, China, France, Germany, Japan, and others.
The recalled product
- Product
- JAGTOME RX 49-20-260-035 Material Number: M00573000
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 101
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 (1)
- Lot Numbers: 27690967 27949032 27604634 27692921 GTIN: 8714729121169
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 31 recalled by Boston Scientific 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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