Swan-Ganz Jr Catheter models recalled due to lumen hub leakage
Becton, Dickinson and Company is recalling Swan-Ganz Jr Catheters (models SGPT54, SGPT64P, SGPT755P) because the blue proximal injectate lumen hub may leak or break due to manufacturing changes, risking infection, medication loss, and blood loss.
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 with a significant risk of harm (infection, medication loss, blood loss) from a structural defect in a critical component. No illnesses or injuries are reported in the source, so the score does not exceed 3 per the rubric criteria.
Plain-English summary
Becton, Dickinson and Company is recalling Swan-Ganz Jr Catheters, Models SGPT54, SGPT64P, and SGPT755P. The catheters may leak or break at the blue proximal injectate lumen hub due to manufacturing process and material changes.
A leaking or broken hub may lead to infection, medication loss, and/or blood loss. This recall affects 183 units distributed worldwide, including throughout the United States and internationally to countries including Japan, Brazil, Canada, Australia, and many others.
Patients and healthcare providers who have these catheters should contact Becton, Dickinson and Company for guidance on product replacement or alternative treatment options.
The recalled product
- Product
- Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
- Manufacturer
- Becton, Dickinson and Company
- Affected units
- 183
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 (5)
- Model-UDI-DI(Expiration): SGPT755P/00690103219388/65869018(6/24/2026)
- 66010501(9/23/2026)
- 67122784(10/28/2027)
- SGPT54/00690103219289/65956343(8/19/2026)
- SGPT64P/00690103219371
Distribution
Part of a larger recall action
This product is one of 3 recalled by Becton, Dickinson and Company 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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