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Sharps 1 GallonRecalls & reported problems

Sharps Compliance Corp. · 1 Gallon Sharps Container · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00634188000912), received between Nov 2, 2018 and Nov 2, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Material Protrusion/Extrusion1

Patient problems

  • Exposure to Body Fluids1
  • Needle Stick/Puncture1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 2, 2018Material Protrusion/Extrusion

    ON (B)(6) 2017- (B)(6) WITH (B)(6) PHARMACY FILED A COMPLAINT AND STATED THE FOLLOWING: AS (B)(6) WAS FINISHING UP A FLU CLINIC SHE WAS HOLDING THE SHARPS CONTAINER IN HER HAND. AS SHE WAS WALKING (B)(6) NOTICED THAT SHE WAS STUCK BY A NEEDLE PROTRUDING THRU THE CONTAINER. (B)(6) WAS STUCK NEAR THE ABDOMEN. ON 09/26/2017 SHARPS SHIPPED 2 REPLACEMENT CONTAINERS AND AN ADDITIONAL LARGER CONTAINMENT SYSTEM TO PACKAGE AND SHIP THE SUSPECTED CONTAINER WITH NEEDLE PROTRUDING THROUGH IT. ON 10/13/2017 - AS OF TODAY THE CUSTOMER HAS YET TO SHIP THE LARGER CONTAINMENT SYSTEM, WITH THE SUSPECT CONTAINER INSIDE, BACK TO SHARPS. AT SUCH TIME AS THE SUSPECT CONTAINER IS RECEIVED FROM THE CUSTOMER AN INSPECTION OF THE SUSPECT CONTAINER WILL BE PERFORMED AND FINDINGS RECORDED IN THE COMPLAINT FILE.

    Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

    MAUDE report 8032240 ↗

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Sources and updates

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