BD Sharps Collector 305613Recalls & reported problems
Becton, Dickinson And Company · SHARPS COLL CHEMO 19GAL YELLOW · Class 2
All models of BD Sharps Collector (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00382903056132), received between Nov 8, 2018 and Dec 11, 2024 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Component Missing” (10 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 Missing10
- Device Misassembled During Manufacturing /Shipping5
- Break2
- Device Markings/Labelling Problem2
- Defective Device1
- Missing Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient7
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
MATERIAL #:305613, BATCH#:4158921. VERBATIM: LOT # ON BOX DOES NOT MATCH LOT # ON PRODUCT. ALSO, THE CATALOG # IS 515031 BUT THAT IS NOT A CHOICE IN PIR SO THIS PIR DOES NOT DESCRIBE THE CORRECT PRODUCT. I VERIFIED THAT THESE BOXES WERE UNOPENED AND THAT MIXED ASSAYS HAD NOT BEEN PLACED IN THE BOX. LOT # ON BOX IS 4179619 LOT # ON ASSAY PACKAGE IS 4158921.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20904228 ↗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 FOLLOWING VERBATIM: HELLO, I AM REACHING OUT TO FILE A COMPLAINT REGARDING AN ITEM. THE ITEM # IS 305613. OUR CUSTOMER STATED THEY RECEIVED AN ITEM WITH NO LIDS ATTACHED. MAY I KNOW THE NEXT STEPS OF THIS PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18207836 ↗MalfunctionNov 7, 2023Component Missing; Component Missing
IT WAS REPORTED THAT BD SHARPS DISPOSAL LID WAS MISSING, THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: CUSTOMER RECEIVED AN UNOPENED CASE OF 305613 THAT WAS MISSING THE LIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18089309 ↗MalfunctionJul 28, 2023Missing Information; Missing Information
IT WAS REPORTED THAT 5 OF THE BD¿ SHARPS COLLECTOR WERE MISSING LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT MISSING LABELS. THE CUSTOMER REPORTED THAT THE BARCODE LABEL WAS NOT ATTACHED TO THE SHIPPING CARTON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17414416 ↗MalfunctionJul 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT 5 OF THE BD SHARPS COLLECTORS WERE NOT LABELED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THE CUSTOMER REPORTED THAT THE PRODUCT WAS NOT LABELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17375789 ↗MalfunctionJun 16, 2023Defective Device; Defective Device
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD¿ SHARPS COLLECTORS LIDS HAD PROBLEMS CLOSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM OUR CREWS ARE HAVING PROBLEMS PUTTING ON THE SLIDING LIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17144446 ↗MalfunctionMay 12, 2023Component Missing; Component Missing
IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTORS LIDS WERE NOT CLOSING PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM "WE HAVE BEEN STOCKING THESE 305609S AND 305613S AND WE HAVE PROBLEMS WITH THE LIDS. OUR CREWS ARE HAVING PROBLEMS PUTTING ON THE SLIDING LIDS. WE HAVE FIVE (5) OPENS BOXES OF THESE SHARPS COLLECTORS WITH NO LIDS... THE FIVE OPEN CASES OF 305609S 19 GALLON SHARPS COLLECTORS ARE OF NO USE TO US WITHOUT LIDS." PER PHONE CALL, WE SPOKE TO THE CUSTOMER OVER THE PHONE TODAY AND THIS WAS HIS RESPONSE, "THERE IS A GREY SEAL AND THEY'RE NOT FITTING ON THE CONTAINERS RIGHT. THE TEAM COULD NOT GET THE PRODUCT TO SEAL. THE CUSTOMER THREW THE LIDS AWAY IF THEY DIDN'T WORK. THE CUSTOMER WAS NOT MISSING LIDS, BUT SINCE THEY WERE BEING DISCARDED, THE STOCK WAS LOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16919882 ↗MalfunctionDec 12, 2022Component Missing; Component Missing
IT WAS REPORTED THAT THE BD¿ CHEMOTHERAPY SHARPS COLLECTOR LID WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 CASE WITHOUT COVERS. SO CANNOT USE THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15964460 ↗MalfunctionOct 4, 2021Component Missing; Component Missing
IT WAS REPORTED THAT THE SHARPS COLL CHEMO 19GAL YELLOW HAD NO LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE CUSTOMER REPORTED THAT THE LID WAS MISSING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12569635 ↗MalfunctionAug 13, 2021Component Missing; Component Missing
IT WAS REPORTED THAT 10 SHARPS COLL CHEMO 19GAL YELLOW WERE MISSING THEIR LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE RECENTLY RECEIVED #2 ORDERS OF SHARPS/HAZARDOUS BINS WITHOUT ANY LIDS. THERE ARE 5 BINS PER ORDER, SO WE ARE SHORT #10 LIDS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12321917 ↗MalfunctionJun 15, 2021Component Missing; Component Missing
IT WAS REPORTED THAT SHARPS COLL CHEMO 19GAL YELLOW WAS MISSING THE LID. THIS OCCURRED ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE DISTRIBUTOR THAT 5 LIDS WERE MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12006095 ↗MalfunctionApr 20, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT SHARPS COLL CHEMO 19GAL YELLOW WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A DAMAGED LID OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S REPORT, THE LID WAS FOUND TO BE DAMAGED UPON ARRIVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11697981 ↗MalfunctionJun 16, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT SHARPS COLL CHEMO 19GAL YELLOW LIDS DON'T WORK PROPERLY. THIS OCCURRED ON 5 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIDS DO NOT WORK SMOOTHLY.
Patient problems: No Patient Involvement
MAUDE report 10157997 ↗MalfunctionMay 13, 2020Break; Break
IT WAS REPORTED PRIOR TO USE THE LID WAS DISCOVERED THAT LID WOULD NOT CLOSE WITH A BD SHARPS¿ COLL CHEMO 19GAL YELLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE LID WILL NOT CLOSE. INJURIES OR ADVERSE EVENT: NO
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10052651 ↗MalfunctionMar 23, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT SHARPS COLL CHEMO 19GAL YELLOW HAD A BROKEN LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THROUGH A PHONE CALL THAT THE CUSTOMER STATED THEY RECEIVED A CASE OF SHARPS COLLECTORS AND 3 OUT OF 5 HAD BROKEN LIDS. PER PHONE CALL: IT WAS REPORTED THROUGH A PHONE CALL THAT THE CUSTOMER STATED THAT THEY RECEIVED A CASE OF SHARPS COLLECTORS AND 3 OUT OF 5 HAD BROKEN LIDS. PLEASE SEND REPLACEMENT CASE AND ALSO REPLACEMENT LIDS."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9869490 ↗MalfunctionMar 19, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT A LID PROBLEM WAS FOUND BEFORE USE WITH A BD¿ SHARPS COLL CHEMO 19GAL YELLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SOME OF THE CONTAINERS WERE SHORTER AND WIDER AND WOULD NOT FIT ON THE TROLLEYS. ALSO, SOME OF THE LIDS WOULD NOT SNAP ON SECURELY." 4 OCCURRENCES WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9856661 ↗MalfunctionDec 9, 2019Break; Break
IT HAS BEEN REPORTED THAT THE BD¿ SHARPS COLL CHEMO 19GAL YELLOW HAS BEEN FOUND EXPERIENCING INABILITY FOR THE LID TO CLOSE BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305613. BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE BIN WILL NOT CLOSE ALL THE WAY ON THE TROLLEY. THE CUSTOMER ORDERED A CHEMO SHARPS COLLECTOR AND FOOT TROLLEY AND STATED THE FOOT TROLLEY IS NOT OPERATING PROPERLY, IT DOES NOT ALLOW THE BIN TO CLOSE ALL THE WAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9438042 ↗MalfunctionMay 31, 2019Component Missing; Component Missing
MATERIAL NO.: 305613; BATCH NO.: 8163918. IT WAS REPORTED THAT BEFORE USE OF THE SHARPS COLL CHEMO 19GAL YELLOW THE SHARPS CONTAINER WAS MISSING A LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DETAILS OF COMPLAINT MISSING LIDS FOR SHARPS CONTAINERS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8658495 ↗MalfunctionMay 22, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT 4 SHARPS COLL CHEMO 19GAL YELLOW LIDS WERE FOUND BROKEN BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER INFORMED TM OF BROKEN LIDS ON CHEMO BIN 305613."
Patient problems: No Information
MAUDE report 8632478 ↗MalfunctionMay 2, 2019Component Missing
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SHARPS COLL CHEMO 19GAL YELLOW EXPERIENCED MISSING LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305613, BATCH NO: 9018920. IT WAS REPORTED THAT THE LIDS ARE MISSING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8575551 ↗MalfunctionNov 8, 2018Component Missing
IT WAS REPORTED THAT FIVE BD¿ CHEMOTHERAPY SHARPS COLLECTORS WERE MISSING LIDS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8051842 ↗
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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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