BD Sharps Collector 305551Recalls & reported problems
Becton, Dickinson And Company · SHARPS COLL NEXT GEN 5.4QT CLEAR 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 clear container for throwing away used needles and other sharps. The 27 reports mostly describe packaging and lid problems: containers arriving without lids, lids that don't fit or won't secure, cracked containers, and torn carton labels. No deaths or injuries were reported, and none of the reports describe any effect on a patient. There are no recalls naming this device, and no reports were filed in the past 12 months.
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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00382903055517), received between Feb 18, 2019 and Nov 14, 2023 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Component Missing” (8 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 Missing8
- Device Markings/Labelling Problem4
- Break3
- Device Damaged Prior to Use3
- Device Misassembled During Manufacturing /Shipping2
- Component Incompatible1
- Component Misassembled1
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Known Impact Or Consequence To Patient8
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2023Component Misassembled; Component Misassembled
IT WAS REPORTED THAT BD SHARPS DISPOSAL LIDS WERE INCORRECT. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: CUSTOMER RECEIVED A BOX OF SHARPS CONTAINERS (3 CASES) AND THEY CONTAINED THE WRONG LIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18137022 ↗MalfunctionOct 17, 2023Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT BD SHARPS DISPOSAL LID DID NOT FIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE VERBATIM: REPORTED ISSUE: THE LIDS DO NOT SECURE TO THE CONTAINER AS NEEDED FOR USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17947073 ↗MalfunctionAug 28, 2023Component Incompatible; Component Incompatible
IT WAS REPORTED THAT THE 21 OF THE BD¿ SHARPS COLLECTOR LIDS DO NOT FIT. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER INJURIES OR ADVERSE EVENT: NO REPORTED ISSUE: I HAD RECEIVED THE WRONG SHARPS YESTERDAY. THE BOX IS THE SAME AS MY REGULAR BUT THE TOPS ARE ACTUALLY DIFFERENT AND DON'T FIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17633651 ↗MalfunctionAug 8, 2023Component Missing; Component Missing
IT WAS REPORTED WHILE USING BD SHARPS COLLECTOR NEXT GEN 5.4QT CLEAR 20/PACK THE LID WAS MISSING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAINERS ARRIVED WITHOUT LIDS. PLEASE REVIEW THE ATTACHED BRANDED PRODUCT QUALITY EVENT FORM REGARDING A COMPLAINT INVOLVING ITEM # US_9874537, WHICH IS YOUR PRODUCT # 305551 FROM OUR CUSTOMER. NO PRODUCT WILL BE SHIPPED TO YOU BY OUR CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17481053 ↗MalfunctionNov 19, 2022Break; Break
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD¿ SHARPS COLLECTORS' LIDS WERE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BROKEN SHARP CONTAINERS; NEED NEW LIDS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15830465 ↗MalfunctionOct 10, 2022Illegible Information; Illegible Information
IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTORS CARTON LABEL WAS TORN. THIS OCCURRED WITH 5 PRODUCTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE PRE-DELIVERY INSPECTION AT THE DISTRIBUTOR'S SIDE, THE LABEL ON THE CARTON WAS FOUND TO BE TORN IN FIVE PRODUCTS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15573383 ↗MalfunctionSep 1, 2022Component Missing; Component Missing
IT WAS REPORTED THAT THE BD¿ CLEAR COUNTERBALANCED DOOR, 5.4 QT EXPERIENCED THE LIDS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15341161 ↗MalfunctionJan 11, 2022Break; Break
IT WAS REPORTED THAT THE BD CLEAR 5.4QT SHARPS COLLECTOR EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THE PRODUCT WAS DAMAGED/CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13226487 ↗MalfunctionNov 7, 2021Missing Information; Missing Information
IT WAS REPORTED THAT BD SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK WAS MISSING LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SHARPS CONTAINERS DID NOT HAVE LABELS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12756110 ↗MalfunctionNov 4, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED WHEN USING THE BD SHARPS COLL¿ NEXT GEN 5.4QT CLEAR 20/PACK THERE WAS NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER RECEIVED A SHARPS CONTAINER THAT DID NOT HAVE THE LABEL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12754595 ↗MalfunctionNov 4, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT BD SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK WAS NOT RECEIVED. THE CUSTOMER RECEIVED THE WRONG PRODUCT WITH THE CORRECT LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, THE WRONG PRODUCT WAS RECEIVED. VERBATIM: CUSTOMER RECEIVED WRONG ITEM WITH CORRECT ITEM # LABEL. THEY ORDER CLEAR CONTAINER AND RECEIVED 2 CASES OF THE SAME SIZE RED CONTAINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12751302 ↗MalfunctionJun 30, 2021Component Missing; Component Missing
IT WAS REPORTED THAT SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK WERE MISSING LIDS. THIS OCCURRED ON 6 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED MISSING LIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12097472 ↗MalfunctionJun 24, 2021Component Missing; Component Missing
IT WAS REPORTED THAT 10 SHARPS COLL NEXT GEN 5.4QT CLEAR EXPERIENCED MISSING LID OR SLIDE LID/CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305551, BATCH NO.: UNKNOWN. 10 CONTAINERS ON HAVE COME WITHOUT LIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12061598 ↗MalfunctionJun 16, 2021Break; Break
IT WAS REPORTED THAT THE LID WAS DIFFICULT TO FIT ONTO THE SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE LID OF ITEM # 305551 IS NOT FITTING INTO THE WALL BRACKET ON ITEM # 305447."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12014149 ↗MalfunctionJun 11, 2021Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT PRODUCT IS DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11987295 ↗MalfunctionJun 9, 2021Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK WAS DAMAGED. THIS OCCURRED ON 12 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SHARPS COLLECTOR WAS MISSING LOWER PARTS THAT WILL FALL INTO DAMAGE PRODUCT. VERBATIM: MISSING LOWER PARTS WILL FALL IN DAMAGE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11971615 ↗MalfunctionJun 9, 2021Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK WAS DAMAGED. THIS OCCURRED ON 12 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER IS MISSING A COMPONENT REGARDING THE SHARPS COLLECTOR. VERBATIM: MISSING LOWER PARTS WILL FALL IN DAMAGE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11971144 ↗MalfunctionFeb 3, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT THE SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK LID WAS FOUND DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "ACCORDING TO THE CUSTOMER'S REPORT, A LID COMPONENT WAS FOUND TO BE DAMAGED."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11276777 ↗MalfunctionAug 20, 2020Component Missing; Component Missing
IT WAS REPORTED THAT THE SHARPS COLL NEXT GEN 5.4QT CLEAR 20 / PACK EXPERIENCED A MISSING LID OR SLIDE LID / CLAMP. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305551, BATCH NO. 0027918. REPORTED ISSUE: MISSING LID.
Patient problems: No Patient Involvement
MAUDE report 10433996 ↗MalfunctionFeb 20, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK HAD A PART OF THE LID MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A PART OF THE LID WAS MISSING.".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9733009 ↗MalfunctionJan 22, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE LABEL ON SIDE OF BOX DOES NOT MATCH THE LABEL THAT IS ON THE TOP WITH A BD SHARPS COLL¿ NEXT GEN 5.4QT CLEAR 20/PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE LABEL ON THE TOP OF THE BOX DID NOT MATCH THE LABEL ON THE SIDE OF THE BOX.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9616524 ↗MalfunctionDec 12, 2019Component Missing; Component Missing
IT WAS REPORTED THAT 5 SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACKS EXPERIENCED A MISSING LID OR SLIDE LID/CLAMP WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305551. BATCH NO. UNKNOWN. PER EMAIL: INJURIES OR ADVERSE EVENT: NO ITEM: 305551 QUANTITY AFFECTED: 1 CS SERIAL/LOT NUMBER: N/A. REPORTED ISSUE: REPORTS THAT SHE IS SHORT BY 5EA LIDS ON THE CONTAINERS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9459108 ↗MalfunctionNov 25, 2019Component Missing; Component Missing
IT WAS REPORTED THAT PRIOR TO USE IT WAS DISCOVERED THAT THE CONTAINERS WERE MISSING 12 LIDS WITH A BD SHARPS COLL NEXT GEN 5.4QT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE CASE WAS MISSING TWELVE LIDS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9372844 ↗MalfunctionNov 7, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BIO HAZARD LABEL WAS MISSING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9292581 ↗MalfunctionApr 10, 2019Component Missing
IT WAS REPORTED THAT 9 SHARPS COLL NEXT GEN 5.4QT CLEAR 20/PACK EXPERIENCED MISSING LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: MATERIAL NO: 305551, BATCH NO: UNKNOWN. IT WAS REPORTED BY THE DISTRIBUTOR ON BEHALF OF THE FACILITY THAT OVER TIME THERE HAVE BEEN NINE SHARPS CONTAINERS THAT WERE MISSING LIDS. USER FACILITY CALLED TO REPORT THAT THEIR END USER CUSTOMER INFORMED THEM THAT OVER TIME THEY ARE MISSING NINE LIDS TO THE SHARPS CONTAINER. NO IMAGES, DATES OR LOT# IS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8501452 ↗
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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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