Instrument, Ent Manual 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

• 2025-01-10Open, ClassifiedReprocessing Controls

  Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE

  Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.

• 2024-04-03Open, ClassifiedUnder Investigation by firm

  Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only

  Inadequate reprocessing validation evidence

• 2023-12-18Open, ClassifiedDevice Design

  Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, 13 cm, REF: 738756; Injection Needle, angular, 13 cm, REF: 738758; Needle, bayonet-shaped, REF: 810505; Needle, Septum, angular, REF: 810506

  The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.

• 2013-05-31TerminatedEmployee error

  GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.

  lack of sterility assurance

• 2006-02-24TerminatedOther

  Acclarent brand Relieva Sinus Inflation Device Kit; Model BID30; The kit contains 1 inflation device, 1-10'' extension tube, 1-20cc syringe, 3-way stop-cock; Manufactured for Acclarent, Inc., 1525-B O''Brien Dr., Menlo Park, CA 94025

  Device sterility may be compromised as evidenced by a loss of package integrity.