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 ↗
Other Container, Sharps devices
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- BD Recykleen™ Sharps Collector 305160Becton, Dickinson And Company · Container, sharps6 reports
- Monoject 8980SCardinal Health, Inc. · Container, sharps4 reports
- Monoject 8506YCardinal Health, Inc. · Container, sharps4 reports
- Monoject 31142222Cardinal Health, Inc. · Container, sharps4 reports
- Monoject 8970YCardinal Health 200, LLC · Container, Sharps3 reports
- Monoject 8932PG2Cardinal Health, Inc. · Container, sharps3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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