JAGTOME RX medical device recalled for sterile barrier breach
Boston Scientific's JAGTOME RX medical device (367 units) is being recalled worldwide due to a sterile barrier breach that compromises device sterility.
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: This is an FDA Class II medical device recall for a sterile barrier breach. Although this hazard poses a risk of patient harm, the source text does not report any illnesses, injuries, or hospitalizations, placing it at the high-risk level per the rubric.
Plain-English summary
Boston Scientific Corporation is recalling 367 units of the JAGTOME RX 39-20-450-025 medical device (Material Number: M00573090). The device has been distributed worldwide, including throughout the United States and internationally to countries such as Australia, Canada, China, France, Germany, Japan, Korea, and others.
The recall is due to a sterile barrier breach that compromises the sterility of the device.
The affected lot numbers are Batch 27632862 and Batch 27855805 (GTIN: 8714729776550). Patients and healthcare providers with this device should contact Boston Scientific Corporation for further guidance.
The recalled product
- Product
- JAGTOME RX 39-20-450-025 Material Number: M00573090
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 367
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: Batch 27632862 27855805 GTIN: 8714729776550
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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