Sharps 1 QtRecalls & reported problems
Sharps Compliance Corp. · 1 Qt. 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 00634188000905), 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
- 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) 2016 AT 4: PM - (B)(6) FROM (B)(6) CALLED (B)(4) AT SHARPS COMPLIANCE, INC., CUSTOMER SUPPORT AND STATED 3-GALLON REPLACEMENT RETURN BOX RECEIVED AND IT INCLUDED A 1 QUART SHARPS CONTAINER MANIFEST (B)(4). SHE ALSO STATED THAT SHE WAS STUCK BY A NEEDLE THAT PROTRUDED THROUGH THE 1-QUART CONTAINER. ON (B)(4) 2016 AT 4:15 PM - (B)(4) CONTACTED (B)(4) OF QUALITY AT SHARPS COMPLIANCE, INC., (B)(4) INSTRUCTED (B)(4) TO CONTACT (B)(6) AT (B)(6) AND EXPLAIN THE FOLLOWING: (B)(6) SHOULD SEEK MEDICAL ATTENTION AND INFORM (B)(6)'S SAFETY OFFICER OF THIS INCIDENT. SHARPS TO SHIP A LARGER CONTAINMENT SYSTEM TO RETRIEVE THE SUSPECTED CONTAINER FOR FURTHER INVESTIGATION. UPON RECEIPT OF RETURNED CONTAINER, SHARPS WILL INVESTIGATE AND THE RESULTS OF THAT INVESTIGATION WILL BE REPORTED TO (B)(6). ON (B)(4) 2016 - REVIEW OF SHARPS ENVIRONMENTAL SERVICES TREATMENT RECORDS SHOW THAT THE SYSTEM IN QUESTION WAS RETURNED DIRECTLY TO SHARPS ENVIRONMENTAL SERVICES (B)(4), (TREATMENT FACILITY) AND TREATED ON (B)(4) 2016, INSTEAD OF BEING RETURNED TO SHARPS COMPLIANCE FOR INSPECTION IN THE PROVIDED, POSTAGE PREPAID 20-GALLON RETURN SYSTEM. NO FURTHER INSPECTION POSSIBLE. ON (B)(6) 2016 ABOUT 11:10
Patient problems: Needle Stick/Puncture
MAUDE report 8032235 ↗
Other Container, Sharps devices
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- BD Recykleen™ Sharps Collector 305160Becton, Dickinson And Company · Container, sharps6 reports
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- 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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