Rasp
FDA adverse event reports and recall history for rasp (product code HTR), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 281
- Deaths
- 1
- Injuries
- 45
- Malfunctions
- 226
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
- 2013-07-01TerminatedPackaging process control
Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical instrument for general use
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
- 2009-01-13TerminatedPackaging process control
Rasps Model #'s: KOMKM5100-37-113 KOMKM-82 STR1675-115 STR5100-37-113 and STR5100-37-115 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
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