BD Sharps Collector 305443Recalls & reported problems
Becton, Dickinson And Company · SHARPS COLL SIDE ENTRY 5.4QT RED · Class 2
All models of BD Sharps Collector (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903054435), received between Jul 1, 2019 and Sep 28, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 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
- Device Markings/Labelling Problem3
- Break1
- Difficult to Open or Close1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- No Patient Involvement2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2023Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR SIDE ENTRY LID WOULD NOT CLOSE PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHARPS CONTAINER LIDS NOT CLOSING PROPERLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17830810 ↗MalfunctionMay 20, 2021Break; Break
IT WAS REPORTED THAT SHARPS COLL SIDE ENTRY 5.4QT RED LID DOES NOT STAY CLOSED. THIS OCCURRED ON 6 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305443 BATCH NO.: 0357920. IT WAS REPORTED THE LIDS DO NOT STAY CLOSED WELL AND THE TOPS POP OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11860011 ↗MalfunctionFeb 25, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT SHARPS COLL SIDE ENTRY 5.4QT RED HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305443 BATCH NO: 0357920. IT WAS REPORTED VIA EMAIL: CUSTOMER RECEIVED AN ITEM WITH A LOT LABELING ISSUE.
Patient problems: No Patient Involvement
MAUDE report 11382570 ↗MalfunctionDec 31, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 5 SHARPS COLL SIDE ENTRY 5.4QT RED WERE MISSING THEIR LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATED LIDS WERE MISSING. NO DAMAGE AND NOT OPENED BOX."
Patient problems: No Patient Involvement
MAUDE report 11102093 ↗MalfunctionNov 14, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem
MATERIAL NO.: 305443, BATCH NO.: 9149933. IT WAS REPORTED THAT BEFORE USE OF THE SHARPS COLL SIDE ENTRY 5.4QT RED THE CONTAINER IS LABELED INCORRECTLY AS REF 305443 5.4QT; BUT IT SHOULD BE 305344 8QT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TOTE IS LABELED INCORRECTLY AS REF 305443 5.4QT. THE PRODUCT SHOULD BE 305344 8QT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9323300 ↗MalfunctionJul 1, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SHARPS COLL SIDE ENTRY 5.4QT RED EXPERIENCED AN INCORRECTLY POSITIONED LABEL WITH THE LABEL BEING PLACED TOO HIGH. PRODUCT DEFECT NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305443; BATCH NO: 8037925. PER CUSTOMER EMAIL: THE SHARPS CONTAINER IS #305443. I AM A CLINICAL OPERATIONS MANAGER. WE JUST HAD AN OSHA WALKTHROUGH AND ONE OF THE FIRST THINGS HE NOTICED IN ALL OF OUR EXAM ROOMS WAS THAT THE LABEL ON THE SHARPS CONTAINER (INDICATING THE FILL LINE) HAS BEEN INCORRECTLY PLACED ON ALL OF OUR SHARP-CONTAINERS. THEY HAVE BEEN PLACED TOO HIGH, AS THEY SHOULD INDICATE APPROXIMATELY 3/4 FULL WHICH IS THE STANDARD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8748636 ↗
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page