DREAMTOME Medical Device Recalled Due to Sterile Barrier Breach
Boston Scientific is recalling 32 units of DREAMTOME endoscopic devices due to a sterile barrier breach that compromises device sterility, creating potential infection risk. No illnesses have been reported.
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 an FDA Class II recall of a medical device with a sterile barrier breach that creates risk of infection—a risk-of-harm product where no injury has yet been reported. The compromised sterility of an endoscopic device presents potential for serious harm if used.
Plain-English summary
Boston Scientific Corporation is recalling DREAMTOME 49-30MM/450CM endoscopic devices due to a sterile barrier breach that compromises device sterility. This breach in the sterile barrier creates a potential risk of infection if the devices are used.
A total of 32 units with lot number 27692922 are affected by this recall. The devices were distributed worldwide, including throughout the United States and to numerous international locations such as Canada, Australia, Japan, and countries across Europe, the Middle East, and Africa.
The FDA classified this recall as Class II. No illnesses or injuries have been reported as of this recall notification. Customers should stop using the recalled devices and contact Boston Scientific for instructions on return or replacement.
The recalled product
- Product
- DREAMTOME 49-30MM/450CM Material Number: M00584030
- Manufacturer
- Boston Scientific Corporation
- Hazard
- sterile-barrier-breach
- infection-risk
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: 27692922 GTIN: 8714729778257
Distribution
Distributed nationwide across the United States.
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