Cutter, Surgical
FDA adverse event reports and recall history for cutter, surgical (product code FZT), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 605
- Deaths
- 0
- Injuries
- 24
- Malfunctions
- 578
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 D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STERILE NAIL NIPPER FLD SPRG 4.5STER25, Model Number 96-2666A; 5) ECONO STERILE NAIL NIPPER 4 1/2" STERILE 50, Model Number 96-2667; 6) ECONO STERILE NAIL NIPPER BRL SPRG 5.5STER25, Model Number 96-2671A; nail procedures
Reports of various packaging issues that may result in a breach of the sterile barrier.
- 2011-02-11TerminatedProcess control
Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071, Manufactured by Maquet Cardiovascular, Wayne, New Jersey. Intended for use by cardiac surgeons during CABG procedures to create an opening in the wall of a vessel.
Pouch integrity may be compromised, resulting in loss of sterility.
- 2008-08-25TerminatedOther
ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
- 2008-08-25TerminatedOther
ENDOPATHETS Endoscopic Linear Cutter, TSW35. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
- 2008-08-25TerminatedOther
ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
- 2008-08-25TerminatedOther
FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B, XLB50S, XPD51S. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
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