Dissector, Surgical, General & Plastic Surgery
FDA adverse event reports and recall history for dissector, surgical, general & plastic surgery (product code GDI), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 307
- Deaths
- 5
- Injuries
- 79
- Malfunctions
- 199
Reports per year
Source: FDA adverse event reports by year received, 2010–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2015-07-24TerminatedOther
Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 2444; EXP (repackager), Covidien (OEM) Specimen retriever bag.
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
- 2012-11-09TerminatedPackaging
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
Some of the sterile packages had broken seals.
- 2012-10-26TerminatedPackaging
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
The tip of the product could come loose or unravel.
- 2010-08-27TerminatedPackaging
V. Mueller Peanut Sponges, Catalog number 23275-470, Sterile, For Single Use Only, Size: 3/8, X-Ray Detectable In Holders, Distributed by Cardinal Health, McGaw Park, IL 60085 USA. There are various uses including as gauze/sponge internal, x-ray detectable and as dissectors.
Sterile product packaging contains weak seals, which may result in compromised product sterility.
- 2009-01-13TerminatedPackaging process control
Lap Instruments/Graspers/Forceps - COLD Model #'s: AUT173030 AUT174233 AUT174317 AUT176613 AUT176647 AUTECATCH10G and ETH5DSG A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either resusable or disposable, intended to be used in various general surgical procedures.
SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
- 2008-01-29TerminatedProcess control
Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Ethicon Endo-Surgery, Inc, Cincinatti, OH 45242
Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices.
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