The recall stems from how the device itself was designed, rather than a manufacturing mistake. The FDA lists 608 recalls with this root cause since 2025, 98 of them Class I (most serious). Most recent report: Aug 19, 2026.
A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive press…
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, i…
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients;…
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients;…
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.