BD Allergy Syringe 305537Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382903055371), received between Apr 22, 2019 and Jul 23, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

10 other recalls cover devices cleared under the same FDA submission (K110771); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE ALLERGY 1ML W/NDL 26X1/2 RB LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SYRINGES WERE LEAKING WHEN DRAWING UP FLUID. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: ITEM: 305537. QUANTITY AFFECTED: 1 CASE. SERIAL/LOT NUMBER: NA. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: SYRINGES WERE LEAKING WHEN THEY TRIED DRAWING FLUID."

  Patient problems: No Information

  MAUDE report 10312314 ↗
• MalfunctionApr 29, 2019Break; Crack; Contamination /Decontamination Problem

  IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A SYRINGE ALLERGY 1ML W/NDL 26X1/2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MATERIAL NO: 305537; BATCH NO: 8172744. IT WAS REPORTED THAT ABOUT 15% OF NEEDLES HAVE DEBRIS ON THEM, AND ANOTHER SYRINGE HAD A CRACKED PLUNGER THAT BROKE OFF WHEN DRAWING UP SERUM. PER CUSTOMER EMAIL: I AM ALSO SENDING BACK THE NEEDLES WITH THE ISSUES. WE HAVE DISPOSED OF ABOUT 15% OF OUR SYRINGES TODAY DUE TO DEBRIS ON THE NEEDLE. WE ALSO HAD AN ISSUE WITH A CRACKED PLUNGER TODAY THAT BROKE OFF WHEN WE TRIED TO DRAW UP SOME SERUM. IT IS ALL THE SAME LOT. WE ARE WAITING ON A NEW BOX AND LOT NUMBER FROM OUR DISTRIBUTER. THERE HAVE BEEN SIMILAR ISSUES WITH OTHER LOTS, BUT NOT TO THE EXTREME OF THE CURRENT LOT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8562812 ↗
• MalfunctionApr 22, 2019Device Contamination with Chemical or Other Material; Material Twisted/Bent

  IT WAS REPORTED THAT BD¿ SYRINGE ALLERGY 1ML W/NDL IS BENT. THIS OCCURRED ON 7 SEPARATE OCCASIONS. FOREIGN MATTER WAS DISCOVERED ON 2 MORE NEEDLES. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305537 BATCH NO: 8172744, AND UNKNOWN IT WAS REPORTED THAT NEEDLES ARE CROOKED ON ABOUT 7 SYRINGES, AND DISCOVERED DEBRIS ON 2 MORE NEEDLES. FACILITY HAS BEEN FINDING DEBRIS ON NEEDLES FOR THE PAST 6 MONTHS. PER SNOW RECORD: 1 - ITEM 305537, LOT 8172744 - THE NEEDLES ARE CROOKED ON ABOUT 7 SYRINGES (SAMPLES AVAILABLE) PLEASE SEND REPLACEMENT PRODUCT OF A DIFFERENT LOT NUMBER INCIDENT DATE IS 4 APR 2018 FOR THIS ONE 2 - FOR THE PAST 6 MONTHS, WHEN UNCAPPED, THERE IS A CLEAR PLASTIC SUBSTANCE ON THE NEEDLE ITSELF (UNKNOWN DATE OF EVENT) - ITEM NUMBER 305537 LOT NUMBER IS UNKNOWN FOR THIS ONE (WILL KEEP SAMPLE IF INCIDENT OCCURS AGAIN. 3. CUSTOMER CALLED BACK TO REPORT FINDING DEBRIS ON 2 MORE NEEDLES WHEN UNCAPPED. LOT NUMBER 8172774.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8536345 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110771. One submission often covers many models, so check the product and lot details in each record.

• Z-2614-2026 · Apr 28, 2026 · Open, Classified
  SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
• Z-2747-2017 · Sep 16, 2016 · Terminated
  BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
• Z-2751-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2752-2017 · Sep 16, 2016 · Terminated
  BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injec
• Z-2750-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care prof
• Z-2753-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2749-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professi
• Z-1936-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1937-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1055-2015 · Dec 19, 2014 · Terminated
  BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 4