BD Sharps Collector 305425Recalls & reported problems
Becton, Dickinson And Company · SHARPS COLL SIDE ENTRY 5.4QT PEARL 12/PK · Class 2
All models of BD Sharps Collector (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00382903054251), received between May 31, 2019 and Sep 21, 2023 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (6 reports).
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 18, 2026.
Most reported problems
Device problems
- Break6
- Component Missing1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2023Defective Component; Defective Component
IT WAS REPORTED WHILE USING BD¿ PATIENT ROOM SHARPS COLLECTOR COUNTERBALANCED SLIDE ENTRY, 5.4 QT, PEARL THE LID DID NOT PROPERLY FIT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LID WILL NOT COMPLETELY FIT ON THE BOTTOM SECURELY. I CALLED THURSDAY AND A REPLACEMENT WAS SENT. THE REPLACEMENT ARRIVED TODAY; HOWEVER, IT HAD NO LID - JUST THE BOTTOM PART OF THE SHARPS COLLECTOR. BOTH CONTAINERS HAVE THE SAME LOT# 9239924 FOR PART# 305425 (XXX PART# 14-826-64B. THE CONTAINERS HAVE DIAGRAMS ON HOW TO PUT THE TOP ON, BUT AS YOU CAN SEE IN THE PHOTO ONE SIDE OF THE CONTAINER HAS A LIP ON THE SIDE WHICH IS PREVENTING THE TOP FROM SECURELY FASTENING TO THE BOTTOM PART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17794899 ↗MalfunctionSep 15, 2023Break; Break
IT WAS REPORTED WHILE USING BD¿ PATIENT ROOM SHARPS COLLECTOR COUNTERBALANCED SLIDE ENTRY, 5.4 QT, PEARL THE LID WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THESE 3 HAVE A TAB MISSING OR IT BROKE OFF. IT IS ON THE BOTTOM OF THE CONTAINERS AND THEY WON¿T LOCK INTO THE HOLDER WITHOUT THE TAB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17761215 ↗MalfunctionApr 23, 2021Break; Break
IT WAS REPORTED THAT SHARPS COLL SIDE ENTRY 5.4QT PEARL 12/PK LIDS DO NOT FIT. THIS OCCURRED ON 12 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: , BATCH NO: 0308910 . IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE THAT THE LIDS DO NOT FIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11721085 ↗MalfunctionMar 31, 2021Break; Break
IT WAS REPORTED THAT SHARPS COLL SIDE ENTRY 5.4QT PEARL 12/PK LIDS DO NOT FIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305425, BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE CUSTOMER RECEIVED ITEM 305425 AND THE LIDS DO NOT FIT THE CONTAINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11593769 ↗MalfunctionMar 30, 2021Break; Component Missing; Break; Component Missing
IT WAS REPORTED THAT SHARPS COLL SIDE ENTRY 5.4QT PEARL 12/PK LIDS DO NOT FIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305425, BATCH NO: UNKNOWN. IT WAS REPORTED THE LIDS DO NOT FIT THE CONTAINERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11593755 ↗MalfunctionJun 14, 2019Break; Break
IT WAS REPORTED THAT THE LID INCLUDED WITH THE SHARPS COLL SIDE ENTRY 5.4QT PEARL 12/PK WAS INCORRECT AND WOULDN'T FIT. THE DEFECT WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATED THE LIDS INCLUDED WITH THE SHARPS CONTAINERS ARE NOT THE CORRECT LIDS."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8699924 ↗MalfunctionMay 31, 2019Break; Break
IT WAS REPORTED THAT 12 SHARPS COLL SIDE ENTRY 5.4QT PEARL 12/PK EXPERIENCED DIFFICULT ASSEMBLY WITH THE LID NOT FITTING ON THE COLLECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305425. BATCH NO. 9026910. PER CUSTOMER, CONTAINERS DO NOT FIT. LIDS ARE DIFFERENT THAN CONTAINERS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8660543 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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