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.
What this means for you
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
- Hazard
- sterile-barrier-breach
- contamination-risk
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateMedline arterial access and insertion kits with lidocaine ampules recalled
FDA (Devices) · 2026-07-08
- ModerateCRE Pro Wireguided Medical Device Recall for Sterile Packaging Breach
FDA (Devices) · 2026-07-08
- ModeratePowerPICC SV Catheters recalled due to deficient lidocaine manufacturing
FDA (Devices) · 2026-07-08
- HighBoston Scientific CRE Pro Wireguided catheters recalled for packaging
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08