Apparatus, Exhaust, Surgical

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

• 2026-04-22Open, ClassifiedPackaging change control

  Flamingo Funnel Small, Model Number SQ20012-01

  Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

• 2026-04-22Open, ClassifiedPackaging change control

  Flamingo Funnel Medium, Model Number SQ20012-02

  Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

• 2026-04-22Open, ClassifiedPackaging change control

  Flamingo Funnel Large, Model Number SQ20012-03

  Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

• 2022-09-26Open, ClassifiedEnvironmental control

  Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560.

  Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

• 2015-09-01TerminatedNonconforming Material/Component

  Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Docking Station (Docker) is a component of the Neptune 2 Waste Management System. The Stryker Rover, another component of the system, is a mobile unit used to suction and collect fluid waste and surgical smoke from a surgical site in an operating room. After collection, the Docker is mated to the Rover and the emptying of fluid waste and cleaning of the canisters occurs automatically. The Actuator Assembly is a component located within the Docker which consists of the fluid coupling parts under a spring loaded cover. Intended Use: 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 electrocautery or laser devices.

  The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. This can cut or dislodge the PTFE seal and cause a leak between the Rover and Docker couplers during docking or leaking from the Rover coupler after docking. The potential hazard is waste fluid and/or fresh water dispensed from the Neptune 2 Rover at the incorrect time.

• 2015-03-27TerminatedError in labeling

  LAPAROSCOPIC TUBING SET, 3/16" X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF 24311 QTY 10/CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

  This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

• 2015-03-27TerminatedError in labeling

  Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, QTY 3/CS, NON STERILE NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

  This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

• 2015-03-27TerminatedError in labeling

  TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

  This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

• 2015-03-27TerminatedError in labeling

  VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

  This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

• 2015-03-27TerminatedError in labeling

  VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include Operating Rooms, Trauma, Endoscopy and Laparoscopy Sites.

  This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.