BD Sharps Collector 305609Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00382903056095), received between Dec 4, 2018 and Nov 1, 2023 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Component Missing” (28 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

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT BD SHARPS CONTAINER HAD NO LID. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: POOR FORMATION. THERE WAS NO LID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048385 ↗
• MalfunctionSep 7, 2023Component Missing; Component Missing

  IT WAS REPORTED THE BD¿ EXTRA LARGE SHARPS COLLECTOR SLIDE TOP, 19 GAL, RED HAD NO LIDS. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: INJURIES OR ADVERSE EVENT: NO. REPORTED ISSUE: NO LIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17700431 ↗
• MalfunctionJul 25, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING USE WITH BD SHARPS COLLECTOR 19GAL RED THE LID WAS NOT ABLE TO CLOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT A DEFORMED LID OF SHARPS COLLECTOR. THE LID COULD NOT BE CLOSED BECAUSE THE HOLE IN THE LID WAS OPEN THE OTHER WAY THAN USUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389689 ↗
• MalfunctionJun 16, 2023Failure to Seal; Failure to Seal

  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."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144449 ↗
• MalfunctionMay 31, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT 2 BD¿ EXTRA LARGE SHARPS COLLECTOR LIDS WERE CLOSED AND CANNOT BE OPENED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: CUSTOMER REPORTED THAT 2 OF OUR LIDS WERE CLOSED AND CANNOT BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032874 ↗
• MalfunctionMay 12, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT 5 BOXES OF BD¿ SHARPS COLLECTORS HAD NO LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "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."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16920391 ↗
• MalfunctionApr 19, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT 5 BD¿ EXTRA LARGE SHARPS COLLECTOR SLIDE TOP WAS MISSING LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS REGARDING THE ITEM 305609 FOR THE PO 4515231937, OUR CUSTOMER ORDERED 5 CASES OF THIS ITEM AND ALL 5 CASES WERE RECEIVED BUT THEY REACHED US STATING THAT THERE IS NO LIDS FOR 1 CASE ( 5 ITEMS ) THAT HAS BEEN DELIVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770686 ↗
• MalfunctionApr 17, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT ONE CASE OF BD¿ SHARPS COLLECTORS WAS DELIVERED WITHOUT LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECEIVED 1 CASE WITHOUT LIDS... OUR CUSTOMER ORDERED 5 CASES OF THIS ITEM AND ALL 5 CASES WERE RECEIVED BUT THEY REACHED US STATING THAT THERE IS NO LIDS FOR 1 CASE ( 5 ITEMS ) THAT HAS BEEN DELIVERED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16756137 ↗
• MalfunctionMar 27, 2023Component Missing; Component Missing

  IT WAS REPORTED WHILE USING BD¿ EXTRA LARGE SHARPS COLLECTOR, HINGE TOP WITH GASKET THE LID WAS MISSING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. INJURIES OR ADVERSE EVENT: NO ITEM: 305609 QUANTITY AFFECTED: 1 CASE SERIAL/LOT NUMBER: (B)(4). REPORTED ISSUE: THEY TOOK THAT OUT OF THE BOX AND WHEN THEY WENT USE THEM THEY NOTICED THE TOPS ARE MISSING THE SLIDING PORTION OF THE TOP. BD¿S MANUFACTURING MUST HAVE NOT INCLUDED THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624708 ↗
• MalfunctionMar 15, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE BD¿ EXTRA LARGE SHARPS COLLECTOR SLIDE LIP WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LIDS DO NOT HAVE THE SLIDER TO CLOSE AND LOCK THE BIN TO PREVENT THE SHARPS FROM FALLING OUT. CUSTOMER DISPOSED OF THE ITEM AND WE ORDERED NEW ONES FOR THE PRACTICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550443 ↗
• MalfunctionMar 12, 2023Break; Break

  IT WAS REPORTED THAT 2 BD¿ SHARPS COLLECTORS WERE FOUND BROKEN IN THE SHIPPING BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER ORDERED 1 CASE OF SHARPS AND RECEIVED 2 CONTAINERS BROKEN. CUSTOMER STATES BOX WAS INTACT AND DID NOT LOOK LIKE IT WAS CRUSHED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527241 ↗
• MalfunctionDec 13, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTORS WAS MISSING THE SLIDING LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT A DEFECTIVE LID OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S REPORT, THE SLIDING LID WAS MISSING FOR ONE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15966279 ↗
• MalfunctionNov 29, 2022Component Missing; Device Misassembled During Manufacturing /Shipping; Component Missing; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT 2 BD¿ SHARPS COLLECTORS WERE RECEIVED WITH NO LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD A CUSTOMER RECEIVE 3 CASES OF 305609, BUT THEY WERE SHORT 2 LIDS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882516 ↗
• MalfunctionOct 24, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR HAD NO LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "ACCORDING TO THE CUSTOMER'S REPORT, THE PRODUCT DID NOT COME WITH ITS LID."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15664361 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED THAT 5 BD¿ SHARPS COLLECTORS HAD BROKEN LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INSPECTION AT THE DISTRIBUTORS SIDE, FIVE LIDS IN A CARTON WERE FOUND TO BE ALL BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15635466 ↗
• MalfunctionSep 29, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT 2 CASES OF BD¿ SHARPS COLLECTORS ARRIVED WITHOUT LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ORDERED 4 CASES AND 2 CASES CAME WITHOUT ANY LIDS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15505820 ↗
• MalfunctionSep 16, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT 2 64L BD¿ EXTRA LARGE SHARPS COLLECTOR DID NOT COME WITH LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 CASES DID NOT COME WITH LIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15441880 ↗
• MalfunctionSep 1, 2022Structural Problem; Structural Problem

  IT WAS REPORTED WHILE USING BD¿ 64L EXTRA LARGE SHARPS COLLECTOR HINGE TOP WITH GASKET LIQUID ABSORBING PAD THE LID WAS INCORRECTLY ASSEMBLED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT MISASSEMBLY OF LID OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S REPORT, THE SLIDING LID WAS ASSEMBLED UPSIDE DOWN. THIS ISSUE WAS FOUND IN THREE PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15339643 ↗
• MalfunctionAug 8, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT WHILE USING THE 64L BD¿ EXTRA LARGE SHARPS COLLECTOR SOMEHOW TWO LIDS BECAME FAULTY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE TYPICALLY ORDER YOUR 19-GALLON SHARP CONTAINERS FROM OWENS AND MINOR AND MEDLINE. SOMEHOW TWO LIDS BECAME FAULTY FOR OUR STAFF HERE AND WE DISCARDED THEM. NOW WE ARE LEFT WITH TWO CONTAINERS THAT DO NOT HAVE LIDS, WHICH PRESENTS A PROBLEM FOR US SHOULD WE GET A HEALTH CODE AUDIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15183972 ↗
• MalfunctionAug 8, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE 64L BD¿ EXTRA LARGE SHARPS COLLECTOR, HINGE TOP LID WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT THE INNER LID WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15182950 ↗
• MalfunctionJul 22, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR EXPERIENCED A MISSING SLIDE CLOSURE DOOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALL CONTAINERS ARE MISSING THE SLIDING LID MAKING THEM UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090036 ↗
• MalfunctionJul 15, 2022Component Missing; Component Missing

  IT WAS REPORTED BY THE CUSTOMER THAT DURING USE OF THE BD SHARPS COLL 19GAL RED ONE LID WAS MISSING, RELATIVE TO THE NUMBER OF BASES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT ONE LID WAS MISSING, RELATIVE TO THE NUMBER OF BASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15030461 ↗
• MalfunctionJul 1, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT 2 BD¿ SHARPS COLLECTORS EXPERIENCED A MISSING LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SLIDING LID WAS MISSING IN TWO PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14893272 ↗
• MalfunctionApr 28, 2022Component Missing; Component Missing

  IT WAS REPORTED BD¿ SHARPS COLLECTOR WAS MISSING ITS LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ORDERED 6 EACH, AND THIS ONE CAME IN A BOX BY ITSELF WITHOUT A COVER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240245 ↗
• MalfunctionApr 20, 2022Component Missing; Component Missing

  IT WAS REPORTED 5 BD¿ SHARPS COLLECTORS WERE MISSING THEIR LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATES THEY DID NOT RECEIVE THE LIDS THAT ARE SUPPOSED TO COME WITH THIS ITEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14163507 ↗