The FDA has posted 6 enforcement recalls of wall vacuum powered operating-room suction apparatus devices since 2025, none of them Class I (most serious). Most recent report: Aug 12, 2026.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older.…
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
Incomplete or partial pouch seals, which may result in a breach in the sterility.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Apparatus, Suction, Operating-Room, Wall Vacuum Powered”). Informational only — verify against the FDA before acting.