BD Allergy Syringe 305541Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00382903055418), received between Jan 14, 2021 and Nov 24, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Defective Component” (6 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20767537 ↗
• MalfunctionJun 28, 2023Break; Break

  IT WAS REPORTED THAT 51 OF THE 1ML ALLERGIST SYRINGE NEEDLES BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: COMMENT: THEY PUT INTO VIAL AND BREAK. THEY PUT INTO VIAL AND BREAK. PER CUST-THEY PUT INTO VIAL AND BREAK OFF. THEY PUT INTO VIAL AND BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17220980 ↗
• MalfunctionAug 16, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT BD¿ ALLERGY SYRINGE HAD DEFECTIVE NEEDLES. NO SERIOUS INJURY REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME OF THE NEEDLES DID NOT HAVE AN OPEN BEVIL OR WERE MISSHAPEN NEEDLES.

  Patient problems: Pain

  MAUDE report 15237069 ↗
• MalfunctionAug 16, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT BD¿ ALLERGY SYRINGE HAD DEFECTIVE NEEDLES. NO SERIOUS INJURY REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME OF THE NEEDLES DID NOT HAVE AN OPEN BEVIL OR WERE MISSHAPEN NEEDLES

  Patient problems: Pain

  MAUDE report 15237027 ↗
• MalfunctionAug 16, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT BD¿ ALLERGY SYRINGE HAD DEFECTIVE NEEDLES. NO SERIOUS INJURY REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME OF THE NEEDLES DID NOT HAVE AN OPEN BEVIL OR WERE MISSHAPEN NEEDLES

  Patient problems: Pain

  MAUDE report 15236743 ↗
• MalfunctionAug 15, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT INACCURATE LABEL INFORMATION WAS FOUND ON A BD¿ ALLERGY SYRINGE BOX. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE FREQUENTLY HAVE BOXES THAT ARE PRINTED ON THE OUTSIDE AS TREATMENT SYRINGES WHEN OPENED THE PACKS MAY BE PRINTED AS TREATMENT UPON OPENING THEY MAY BE TESTING SYRINGES AND VICE/ VERSA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229689 ↗
• MalfunctionAug 15, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE PLUNGER ROD WAS MALFORMED ON THE BD¿ ALLERGY SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SOME OF THE PLUNGERS WERE MALFORMED."

  Patient problems: Pain

  MAUDE report 15228452 ↗
• MalfunctionAug 15, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT BD¿ ALLERGY SYRINGE HAD A MALFORMED PLUNGER. NO SERIOUS INJURY REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME OF THE PLUNGERS WERE MALFORMED.

  Patient problems: Pain

  MAUDE report 15228135 ↗
• MalfunctionAug 15, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED THAT THE BD¿ ALLERGY SYRINGE HAD A DISCOLORED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER CALLED STATING THAT THEY RECEIVED A DEFECTIVE PRODUCT."

  Patient problems: Pain

  MAUDE report 15227709 ↗
• MalfunctionAug 15, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD¿ ALLERGY SYRINGE EXPERIENCED DEFECTIVE PLUNGER. NO SERIOUS INJURY REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME OF THE PLUNGERS WERE MALFORMED.

  Patient problems: Pain

  MAUDE report 15224683 ↗
• MalfunctionAug 15, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED THAT BD¿ ALLERGY SYRINGE HAD DISCOLORED NEEDLES. NO SERIOUS INJURY REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OTHER THING I NOTICED ABOUT THE NEEDLES IS THAT SOME OF THEM HAVE A MATTE APPEARANCE VS THE USUAL SILVER APPEARANCE THAT OUR NEEDLES USUALLY HAVE.

  Patient problems: Pain

  MAUDE report 15224678 ↗
• MalfunctionAug 15, 2022Unexpected Color; Unexpected Color

  IT WAS REPORTED THAT THE BD¿ ALLERGY SYRINGE HAD A DISCOLORED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER CALLED STATING THAT THEY RECEIVED A DEFECTIVE PRODUCT."

  Patient problems: Pain

  MAUDE report 15224579 ↗
• MalfunctionNov 19, 2021Device Contamination with Chemical or Other Material; Inaccurate Information; Missing Information; Device Contamination with Chemical or Other Material; Inaccurate Information; Missing Information

  IT WAS REPORTED THAT IN SOME CASES, THE INCORRECT NEEDLES WERE RECEIVED IN THE TRAY OF BD¿ ALLERGY SYRINGES. IN OTHER CASES, THE LABELING ON THE PACKAGING WAS INCORRECT OR MISSING INFORMATION. ADDITIONALLY, WHITE OR RED FIBERS WERE FOUND ON THE NEEDLE WHEN REMOVING THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN YOU OPEN UP EACH INDIVIDUAL TRAY SOME ARE ACTUALLY THE TESTING NEEDLES (1/2 ML 27G 3/8). WE HAVE SEEN THIS MULTIPLE TIMES, AS WELL AS THE OPPOSITE WAY, WHERE WE ORDER TESTING NEEDLES. IT SAYS TESTING ON THE SHIPPING BOX, BUT OPEN EACH INDIVIDUAL TRAY AND IT IS TREATMENT NEEDLES INSTEAD OF TESTING. WE HAVE ALSO HAD A FEW INDIVIDUAL TRAYS THAT HAVE NO LABEL OR PRINT ON THEM OTHER THAN THE LOT AND EXPIRATION DATE. SOMETHING EVEN MORE CONCERNING IS THAT WE HAVE FOUND SO MANY TREATMENT NEEDLES THAT WHEN WE PULL OFF THE CAP, THERE IS WHITE OR RED FIBERS ON THE NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12847666 ↗
• MalfunctionJan 14, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THERE WAS NO EXPIRATION DATE ON THE SYRINGE ALLERGY 1ML W/NDL 27X3/8 IB PACKAGING. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED ITEM # 305541, LOT # 6111954 NO EXPIRATION DATES ON PACKAGES."

  Patient problems: No Patient Involvement

  MAUDE report 11175022 ↗

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-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-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-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-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-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