Medical device sterile barrier breach in Boston Scientific HYDRATOME RX
Boston Scientific is recalling HYDRATOME RX 49-30MM/260CM devices worldwide because sterile barriers are compromised. The manufacturing defect affects 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: FDA Class II recall involving a manufacturing defect that compromises sterile barriers. No hospitalizations or illnesses are reported in the source. Classified as a risk-of-harm product where injury has not yet been reported, per the rubric's criteria for High severity.
Plain-English summary
Boston Scientific Corporation is recalling the HYDRATOME RX 49-30MM/260CM medical device (Material Number: M00583010) worldwide. The recall affects specific lot numbers: 27641142 and 28045346 (GTIN: 8714729755166).
The device is being recalled because its sterile barrier has been compromised during manufacturing. A sterile barrier breach may result in contamination of the medical device.
This device has been distributed worldwide, including throughout the United States and internationally to Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and many other countries.
Patients and healthcare providers who have this device should contact Boston Scientific for instructions regarding device return or replacement. Healthcare facilities should verify lot numbers and consult with Boston Scientific regarding appropriate next steps.
The recalled product
- Product
- HYDRATOME RX 49-30MM/260CM Material Number: M00583010
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
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: 27641142 28045346 GTIN: 8714729755166
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.
See all 31 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · sterile barrier breach
See all →- ModerateBoston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk
FDA (Devices) · 2026-08-12
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
- ModeratePhantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches
FDA (Devices) · 2026-07-29
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
Similar recalls
- SevereBoston Scientific CRE Wireguided Medical Device Recall Sterile Breach
FDA (Devices) · 2026-07-08
- HighCRE Pro Wireguided medical device sterile packaging breach recall
FDA (Devices) · 2026-07-08
- HighCRE Wireguided 18-20mm 240cm medical devices recalled for sterile breach
FDA (Devices) · 2026-07-08
- ModerateCRE Wireguided Device Recall Due to Potential Sterile Packaging Breach
FDA (Devices) · 2026-07-08
- ModerateCRE Wireguided 8-10mm 240cm Medical Device Recall Notice
FDA (Devices) · 2026-07-08
- HighFlexima Biliary Catheter System Kits recalled for potential sterile barrier failure
FDA (Devices) · 2024-09-25