Apparatus, Suction, Ward Use, Portable, Ac-Powered

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-06-01Open, ClassifiedNonconforming Material/Component

  Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System

  It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.

• 2026-02-11Open, ClassifiedNonconforming Material/Component

  Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;

  units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.

• 2016-08-23TerminatedUnder Investigation by firm

  120 V Neptune 3 Rover, Model Number: 0703-001-000

  Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if high levels of electromagnetic interference are present in the operating room.

• 2016-07-20TerminatedComponent design/selection

  DeVilbiss Model 7305P-D Powered Suction Unit

  A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.

• 2015-07-20TerminatedNonconforming Material/Component

  THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical aspirator

  Vacuum pump may not perform to specification.

• 2015-07-20TerminatedNonconforming Material/Component

  THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 Product Usage: medical aspirator

  Vacuum pump may not perform to specification.

• 2015-07-20TerminatedNonconforming Material/Component

  THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator

  Vacuum pump may not perform to specification.

• 2015-07-17TerminatedNonconforming Material/Component

  0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover 0702-002-000, Neptune 2 Rover Ultra (230V) 0702-002-000ES, Neptune 2 Rover (230V) Spanish 0702-002-000FI, Neptune 2 Ultra Rover (230V) Finnish 0702-002-000IT, Neptune 2 Rover (230V) Italian 0702-002-000R, Repair Neptune 2 Rover Ultra (230V) Product Usage: The Neptune 2 Waste Management System is intended to be used in the operating room, pathology, surgical centers, and doctor s offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electro cautery or laser devices. Contraindication: connection of the Neptune 2 Waste Management System directly to chest tubes or other closed wound drains. The Stryker Neptune 2 Rover is a mobile unit used to suction, collect fluid waste, and evacuate surgical smoke from a surgical site during operation. Fluid waste is removed from the surgical site through suction tubing connected to inlet ports of disposable manifolds installed in the rover. The Diverter Valve Assembly consists of two diverter valves with three hoses, one inlet and two outlets. The sole purpose of the Diverter Valve Assembly is to direct/divert water from the fresh water inlet to either the large canister or small canister via the pre-fill tank.

  Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to complaints related to installation failures of the Neptune 2 diverter valve assembly during docking.

• 2014-09-13TerminatedNonconforming Material/Component

  Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.

  suction canister lids may have occluded ports.

• 2014-01-31TerminatedDevice Design

  Neptune 2 Rover Ultra Waste Management System.

  The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field to the recently obtained 510(k) clearance specifications.