Becton, Dickinson and Company FDA Recalls

4 recalls on file across devices, 0 of them Class I and 4 still open. Matched by name to BDX.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cClass IIAug 11, 2026Due to incorrect switching of Channel 1 and 2 on the module	Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.	Class IIDevices	Aug 11, 2026
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755PClass IIApr 8, 2026Catheters may, due to a manufacturing process and material c	Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal inject	Class IIDevices	Apr 8, 2026
Swan-Ganz Pacing Catheter, Models: D200F7;Class IIApr 8, 2026Catheters may, due to a manufacturing process and material c	Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal inject	Class IIDevices	Apr 8, 2026
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 83Class IIApr 8, 2026Catheters may, due to a manufacturing process and material c	Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal inject	Class IIDevices	Apr 8, 2026