Boston Scientific JAGTOME RX medical device recalled for sterile barrier breach
Boston Scientific has recalled 1,447 units of the JAGTOME RX 39-30-260-025 medical device due to a compromised sterile barrier that affects device sterility. The affected devices were 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: This is a Class II recall for a medical device with a sterile barrier breach, which presents a risk of harm if contamination occurs. No illnesses or injuries have been reported, so the hazard remains theoretical, fitting the High severity criteria.
Plain-English summary
Boston Scientific Corporation is recalling 1,447 units of the JAGTOME RX 39-30-260-025 medical device due to a sterile barrier breach that compromises the device's sterility.
The affected devices were distributed worldwide to numerous countries including the United States, Australia, Canada, China, France, Germany, Japan, and numerous others. Eight specific lot numbers are included in this recall: 27465196, 27566099, 27603464, 27641141, 27731956, 27855806, 27998506, and 28297081.
A compromised sterile barrier means the device does not maintain the sterility standards required for its intended medical use. The FDA has classified this as a Class II recall.
The recalled product
- Product
- JAGTOME RX 39-30-260-025 Material Number: M00573100
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 1,447
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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