BD Sharps Collector 305517Recalls & reported problems
Becton, Dickinson And Company · SHARPS COLL NEXT GEN 5.4QT RED 20/PACK · Class 2
All models of BD Sharps Collector (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Sharps Collector is a red container used to hold and dispose of used needles and other sharps. The 53 reports mostly describe packaging and assembly issues — containers arriving without lids, without labels or biohazard stickers, with lids that don't fit, or damaged before use. One report describes a needlestick injury; no deaths were reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 53
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00382903055173), received between Dec 12, 2017 and Apr 6, 2024 — classified as 1 injury, 52 malfunctions.
The most frequently reported specific device problem is “Component Missing” (27 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.
Reports received per month
Most reported problems
Device problems
- Component Missing27
- Device Markings/Labelling Problem8
- Device Damaged Prior to Use6
- Defective Component2
- Device Misassembled During Manufacturing /Shipping2
- Fitting Problem2
- Material Deformation2
- Missing Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Known Impact Or Consequence To Patient10
- Needle Stick/Puncture2
- No Patient Involvement2
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT BD SHARPS DISPOSAL LABEL WAS MISSING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: CUSTOMER REPORTED THAT ONE LABEL FOUND TO BE MISSING WHEN CHECKING PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19056764 ↗MalfunctionNov 26, 2023Component Missing; Component Missing
IT WAS REPORTED THAT BD SHARPS DISPOSAL WAS MISSING LIDS. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REPORTED ISSUE: MISSING LIDS. INJURIES OR ADVERSE EVENT: NO. ITEM: 305517. QUANTITY AFFECTED: 6 EACH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18207857 ↗MalfunctionAug 22, 2023Component Missing; Component Missing
IT WAS REPORTED THAT THE BD¿ NEXT GENERATION PATIENT / EXAM ROOM SHARPS COLLECTOR, 5.1L WAS MISSING LIDS. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: MISSING LID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17597667 ↗MalfunctionJun 19, 2023Component Missing; Component Missing
IT WAS REPORTED THAT THE BD¿ NEXT GENERATION PATIENT / EXAM ROOM SHARPS COLLECTOR, 5.1L WERE MISSING THE LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED ABOUT MISSING THE SLIDING LID. WHEN CHECKED BEFORE USE, THERE WAS NO SLIDING LID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17159518 ↗MalfunctionApr 18, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR WAS MISSING THE LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, THERE WAS NO BIOHAZARD STICKER ON IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16765637 ↗MalfunctionMar 18, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR WAS MISSING LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER'S VERBATIM REPORT IS THAT THERE WAS NO STICKER AFFIXED TO THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16569966 ↗MalfunctionMar 15, 2023Defective Component; Defective Component
IT WAS REPORTED WHILE USING BD¿ NEXT GENERATION PATIENT / EXAM ROOM SHARPS COLLECTOR, 5.1L THE LID DID NOT FIT PROPERLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 20/20/2023 THE CUSTOMER RECEIVED SHARPS CONTAINER #305517 WITH THE INCORRECT LID AND STATED IT WOULD NOT FIT THE SHARPS CONTAINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16550453 ↗MalfunctionFeb 15, 2023Missing Information; Missing Information
IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR HAD NO LABEL ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT A MISSING LABEL OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S REPORT, IT WAS FOUND THAT THERE WAS NO LABEL AFFIXED TO THE PRODUCT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16383838 ↗MalfunctionFeb 8, 2023Component Missing; Component Missing
IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE DISTRIBUTOR'S REPORT, ONE LID WAS FOUND TO BE MISSING UPON PRODUCT ARRIVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16319684 ↗MalfunctionFeb 8, 2023Component Missing; Component Missing
IT WAS REPORTED WHILE USING BD¿ NEXT GENERATION PATIENT / EXAM ROOM SHARPS COLLECTOR, 5.1L THE LID WAS MISSING. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED TWO CONTAINERS WITHOUT LIDS AND COULDN'T USE THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16318483 ↗MalfunctionFeb 1, 2023Component Missing; Component Missing
IT WAS REPORTED THAT 2 BD¿ SHARPS COLLECTOR HAD NO LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS MISSING TWO LIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16278788 ↗MalfunctionJan 26, 2023Component Missing; Component Missing
IT WAS REPORTED THAT 10 BD¿ SHARPS COLLECTORS HAD NO LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE 10 SMALL SHARPS CONTAINERS, BUT I HAVE NO LIDS FOR THEM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16250762 ↗MalfunctionNov 28, 2022Material Deformation; Material Deformation
IT WAS REPORTED WHILE USING BD SHARPS COLL NEXT GEN 5.4QT RED 20/PACK THE LID WAS BROKEN. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: CRACKED LID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15873429 ↗MalfunctionSep 24, 2022Component Missing; Component Missing
IT WAS REPORTED THAT 6 BD SHARPS COLL NEXT GEN 5.4QT RED 20/PACK WERE MISSING LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOMEHOW OUR SOUTH LOCATION ENDED UP WITH 6 CONTAINERS WITHOUT LIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15478544 ↗MalfunctionAug 9, 2022Missing Information; Missing Information
IT WAS REPORTED THAT THE BD SHARPS COLL NEXT GEN 5.4QT RED HAS MISSING LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, WHEN TAKING THE PRODUCT OUT OF THE CARTON, THE HCP FOUND THAT THE LABEL WAS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15195755 ↗MalfunctionAug 8, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE 8 5.4 QT BD¿ NEXT GENERATION PATIENT COLLECTOR HAD NO LABEL ON THE BASE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A MISSING LABEL OF SHARPS COLLECTOR. DURING THE INSPECTION AT THE DISTRIBUTOR'S SIDE BEFORE DELIVERY TO A CUSTOMER, IT WAS FOUND THAT THERE WAS NO LABEL ONTO THE BASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15183089 ↗MalfunctionJun 2, 2022Component Missing; Component Missing
IT WAS REPORTED THAT 4 BD SHARPS CONTAINERS AND ACCESSORIES HAD LID ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED THAT 2 ARRIVED WITH NO LIDS AND 2 ARRIVED WITH LIDS THAT WERE LOCKED SHUT THAT CAN NOT BE OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14573541 ↗MalfunctionMay 11, 2022Component Misassembled; Component Misassembled
IT WAS REPORTED WHILE USING BD SHARPS COLL NEXT GEN 5.4QT RED 20/PACK THE LID WAS MISSING. THIS OCCURRED 5 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED ABOUT MISSING INNER LIDS (MOVABLE PARTS) OF SHARPS COLLECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14353988 ↗MalfunctionMay 9, 2022Component Missing; Component Missing
IT WAS REPORTED THAT BD 5 SHARPS COLL NEXT GEN 5.4QT RED 20/PACK WERE MISSING THEIR LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE CUSTOMER REPORTED ABOUT MISSING INNER LIDS (MOVABLE PARTS) OF SHARPS COLLECTOR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14342553 ↗MalfunctionApr 20, 2022Fitting Problem; Material Deformation; Fitting Problem; Material Deformation
IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR LID LATCH WAS DEFORMED AND COULDN'T BE ASSEMBLED ONTO THE COLLECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THIS IS A REPORT ABOUT A DEFORMED LID OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S REPORT, THE LID WAS DEFORMED AND IT COULD NOT BE ASSEMBLED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14160432 ↗MalfunctionFeb 3, 2022Component Missing; Component Missing
IT WAS REPORTED THAT 3 BD SHARPS COLLECTORS 5.4QT RED HAD THE LID MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED I HAVE 3 OF THE SHARPS CONTAINER RED 5.4QT YOUR ITEM NUMBER 305517 WITHOUT THE LIDS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13446728 ↗MalfunctionJan 19, 2022Component Missing; Component Missing
IT WAS REPORTED THAT 8 5.4 QT BD¿ NEXT GENERATION PATIENT COLLECTOR WERE MISSING THE LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER RECEIVED CONTAINERS MISSING THE LIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13290920 ↗MalfunctionJan 14, 2022Defective Component; Defective Component
IT WAS REPORTED THAT BD SHARPS COLLECTOR 5.4QT RED EXPERIENCED A CASE OF LID DAMAGE, AND A CASE OF DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HCP NOTICED THAT THE ONE SIDE OF THE ROTATION AXIS OF THE LID AND THE BOTTOM SURFACE OF THE BASE WERE DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13261757 ↗MalfunctionJan 7, 2022Break; Break
IT WAS REPORTED BD SHARPS COLL NEXT GEN 5.4QT RED 20/PACK HAD A BROKEN LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "PART OF THE LID IS MISSING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13197349 ↗MalfunctionJan 6, 2022Component Missing; Component Missing
IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR WAS MISSING ITS LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MISSING LIDS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13182290 ↗
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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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