Cannula, Surgical, General & Plastic Surgery

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

• 2025-01-16Open, ClassifiedUnder Investigation by firm

  ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO STERILE FRAZIER TUBE 7FR STERILE CS/25, Model Number 96-5435; 5) ECONO STERILE FRAZIER TUBE 8FR STERILE CS/25, Model Number 96-5436; 6) ECONO STERILE FRAZIER TUBE 9FR STERILE CS/25, Model Number 96-5437; 7) ECONO STERILE FRAZIER TUBE 10FR STERILE CS25, Model Number 96-5438; 8) ECONO STERILE FRAZIER TUBE 12FR STERILE CS25, Model Number 96-5439; 9) ECONO STERILE FRAZIER TUBE 14FR STERILE CS25, Model Number 96-5440; 10) ECONO STERILE BARON SUCT TUBE 3FR STER CS25, Model Number 96-5492; 11) ECONO STERILE BARON SUCT TUBE 5FR STER CS25, Model Number 96-5493; 12) ECONO STERILE BARON SUCT TUBE 7FR STER CS25, Model Number 96-5494; suction devices

  Reports of various packaging issues that may result in a breach of the sterile barrier.

• 2016-05-26TerminatedEquipment maintenance

  Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories

  Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

• 2008-12-24TerminatedManufacturing material removal

  Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx Only. Catalog Numbers: 100-005-001 & 100-005-002. Used for incisions made for positioning the laparoscopic cannulas or ports.

  The stainless steel tips on the Genicon 5mm Pyramidal Trocar exhibited contamination that resembled rust and there was also pitting on the tip of the trocar.

• 2005-07-22TerminatedOther

  ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, lot code 1905.

  Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infection

• 2003-02-05TerminatedOther

  25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End

  The wrong product in the box.

• 2003-02-05TerminatedOther

  25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End

  The wrong product in the box.

• TerminatedNonconforming Material/Component

  MicroAire PAL Cannula Product Usage - Power Aspiration Device

  MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery. Accordingly, the PAL-R4011XL has also been put on production hold until further notice.

• TerminatedUnder Investigation by firm

  Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.

  Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.

• TerminatedEquipment maintenance

  Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

  single use devices labeled as sterile may not have been adequately sterilized

• TerminatedMixed-up of materials/components

  Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices that are connected to the hospital suction system to remove debris and blood from the surgical field.

  There was incorrect raw material used in the production of the identified lot.