Monoject 8507SARecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521023284), received between Apr 2, 2018 and Jun 3, 2024 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2024Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT A MICROBIOLOGY COLLEAGUE WAS STUCK RECENTLY WHILE DISPOSING A NEEDLE INTO THE SHARPS CONTAINER. IT SEEMS AS THOUGH THIS CONTAINER DOESN¿T ALWAYS OPERATE PROPERLY ¿ FLAP GETS STUCK, DOESN¿T DROP NEEDLES, ETC. PER ADDITIONAL INFORMATION RECEIVED, BLOOD WORK WAS TAKEN AND AN HEP B BOOSTER WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19448873 ↗
• MalfunctionSep 7, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE SHARPS CONTAINERS ARE DIFFICULT TO FILL WITHOUT THE DOOR STICKING SHUT, ISSUES WITH SHARPS GETTING STUCK IN DOOR AND STAFF ALMOST HAVING NEEDLE EXPOSURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374214 ↗
• MalfunctionSep 7, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT ON (B)(6) 2022, A NURSE IN THE ED HAD AN EXPOSURE RELATED TO THE NEW SHARPS CONTAINERS. WHEN THE NURSE WENT TO PUT A SHARP IN THE CONTAINER, THERE WAS AN OLD SHARP THAT WAS HANGING THERE AND WHEN IT FELL INTO THE BOX, IT SPLASHED BLOOD ON HER FACE, ARM, CHEST AND NECK.

  Patient problems: Exposure to Body Fluids

  MAUDE report 15372836 ↗
• MalfunctionSep 7, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE SHARPS CONTAINERS ARE NOT ABLE TO BE USED TO FULL CAPACITY AS THINGS GET STUCK IN THEM. THEY HAVE HAD TO CHANGE OUT SEVERAL OF THE CONTAINERS THAT ARE ONLY 1/4 FULL DUE TO THE OPENING BEING STUCK SHUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15371591 ↗
• MalfunctionApr 29, 2021Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE LID WOULD LOCK CLOSED WHEN THE CONTAINER WAS ONLY PARTIALLY FULL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11746146 ↗
• MalfunctionDec 17, 2020Defective Component; Defective Component

  THE CUSTOMER REPORTED THAT THE SHARPS CONTAINER LIDS ARE NOT ENGAGING PROPERLY AND KEEP POPPING BACK UP. IT LOOKS LIKE THE LIDS OR THE CONTAINER ARE SLIGHTLY WARPED. THE LIDS WOULD SNAP IN FINE ON ONE SIDE, BUT POP BACK UP ON THE OTHER. THERE WAS NO HARM TO PATIENTS OR STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11028577 ↗
• MalfunctionApr 21, 2020Component Incompatible; Component Incompatible

  THE CUSTOMER REPORTED THAT THE LIDS DO NOT FIT THE SHARPS CONTAINERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9981918 ↗
• MalfunctionFeb 28, 2020Break; Break

  THE CUSTOMER REPORTED THE SHARPS CONTAINERS ARRIVED WITH BUSTED CORNERS AND THE LIDS HAD PIECES BREAKING OFF OF THEM.

  Patient problems: No Patient Involvement

  MAUDE report 9768981 ↗
• MalfunctionDec 27, 2019Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT THE NEEDLE PROTRUDED THROUGH THE SHARP CONTAINER. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER STATED THAT NO INJURIES WERE SUSTAINED AS A RESULT OF THIS INCIDENT. THE ISSUE WAS NOTICED DURING A ROUTINE EQUIPMENT CHECK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9526062 ↗
• MalfunctionSep 30, 2019Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT THE LID DIDN'T FIT THE CONTAINER THEY ORDERED BECAUSE IT WAS TOO SMALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9135638 ↗
• MalfunctionAug 30, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT THE OPENING OF THE SHARPS CONTAINER IS STICKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8950522 ↗
• MalfunctionAug 30, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT THE OPENING OF THE SHARPS CONTAINER IS STICKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8950509 ↗
• InjuryApr 2, 2018Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER STATES THAT A NEEDLE WENT THROUGH THE PLASTIC (SHARPS CONTAINER) AND INJURED THE PHYSICIAN. THE NEEDLE STICK OCCURRED ON THE PHYSICIAN'S LEFT HAND.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7390248 ↗