BD Recykleen™ Sharps Collector 305160Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903051601), received between Jul 10, 2019 and Jun 8, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT UNSPECIFIED BD¿ SHARPS CONTAINER WAS RECEIVED WITH BROKEN LIDS. THIS OCCURRED ON 12 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE FACILITY REPRESENTATIVE THAT THEY HAVE RECEIVED BROKEN LIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963342 ↗
• MalfunctionApr 2, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT SHARPS COLL 6GAL RED SMALL OPEN CAP LID WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT THE SC LID WAS BROKEN ON ARRIVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611399 ↗
• MalfunctionDec 22, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE SHARPS COLL 6GAL RED SMALL OPEN CAP LID WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THE LID WAS FOUND TO BE BROKEN ON ARRIVAL OF THE PRODUCT."

  Patient problems: No Patient Involvement

  MAUDE report 11061542 ↗
• MalfunctionJul 21, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE SHARPS COLL 6GAL RED SMALL OPEN CAP WAS MISSING ITS LID. THIS WAS NOTICED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ISSUE WITH LID ¿ (EXAMPLE: MISSING LID, CRACKED, BROKEN) ¿ LIDS MISSING."

  Patient problems: No Patient Involvement

  MAUDE report 10301761 ↗
• MalfunctionDec 20, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A MISSING LABEL WAS FOUND BEFORE USE WITH A SHARPS COLL 6GAL RED SMALL OPEN CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LABEL SHOULD BE PUT ON THE COLLECTOR WAS MISSING."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9506090 ↗
• MalfunctionJul 10, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT BD¿ SHARPS COLL 6GAL RED SMALL OPEN CAP LID WAS CHIPPED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CORNER OF THE LID WAS CHIPPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8776078 ↗