N/A 309647Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00382903096473), received between Dec 26, 2018 and Mar 18, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Defective Component” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Defective Component; Defective Component

  NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21636054 ↗
• MalfunctionJan 29, 2025Defective Component; Defective Component

  MATERIAL#:309647, BATCH#: UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGE 5ML LS SP125 STOPPER WAS DEFECTIVE / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOMETHING WITH THE RUBBER. I DON'T HAVE THE FULL EXPLANATION OF THE ISSUE. I ALSO DON'T HAVE A LOT NUMBER. ADDITIONAL INFORMATION PROVIDED: PLEASE PROVIDE THE DATE OF EVENT: AUG 26, 2024. 2. PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE: NOT AVAILABLE. 3. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? WE HAVE THE SYRINGES WITH THE SAME LOT#, BUT WITHOUT VISIBLE DEFECT. IF YOU WOULD LIKE TO HAVE THEM, OUR ADDRESS IS: LABORATORY, SAMPLE PROCUREMENT, (B)(6). 4. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THE DEFECTIVE SYRINGES WERE DISCOVERED BEFORE BLOOD COLLECTIONS, SO NO HARM TO PATIENTS. ALL SYRINGES WITH THE SAME LOT NUMBER WERE REMOVED FROM CIRCULATION IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21270021 ↗
• MalfunctionSep 29, 2024Defective Component; Defective Component

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20330383 ↗
• MalfunctionFeb 8, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD¿ LUER SLIP SYRINGE STERILE, SINGLE USE, 5 ML HAD LIQUID IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY FOUND A HAND FULL OF THE 10 ML SYRINGES THAT HAD AN OIL SUBSTANCE IN THEM AND WONDERED IF THIS WAS SOMETHING THAT CAME FROM THE MANUFACTURE AND WAS STILL SAFE TO USE OR IF THEY SHOULD REMOVE ANY THAT WERE FOUND TO HAVE THE OIL INSIDE THE SYRINGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480849 ↗
• MalfunctionJul 9, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 300 SYRINGE 5ML LS SP125 EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE DISCOVERED A STICKY SUBSTANCE INSIDE OF MULTIPLE SYRINGES INSIDE THE SEALED PACKAGING. WE AUDITED ALL SEALED CASES WITH THIS LOT NUMBER AND FOUND IMPACTED PRODUCT IN THREE DIFFERENT CASES. WHEN AUDITING A DIFFERENT LOT NUMBER, WE DID NOT IDENTIFY THE SAME ISSUE. QTY IMPACTED  300 EA. PHYSICAL CONFIRMATION OF 10 DIFFERENT SYRINGES (ALL 300 ARE SEQUESTERED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12145920 ↗
• MalfunctionNov 21, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 5ML LS SP125 EXPERIENCED POOR PERFORATION ON PACKAGING WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309647; BATCH NO: 9115907. INCIDENT DETAILS: THE 5 ML SLIP TIP SYRINGES PACKAGES ARE NOT COMPLETELY SEALED AND ARE BREAKING APART. WE USE THE 5 ML SLIP TIP ON OUR STERILE TRAYS AND THIS LENDS ITSELF TO AN ACCIDENTAL CONTAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9354827 ↗
• MalfunctionNov 21, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO USE IT WAS DISCOVERED THAT THE PACKAGES ARE NOT SEALED PROPERLY WITH A BD SYRINGE 5ML LS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STERILE PACKAGING IS NOT SEALED PROPERLY. SYRINGES FALLING OUT OF PACKAGING INTO NON STERILE BINS, CANNOT USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9354804 ↗
• MalfunctionNov 21, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE SYRINGE 5ML LS SP125 PACKAGING WAS NOT COMPLETELY SEALED AND THE PRODUCT WAS FOUND "FALLING OUT" BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PACKAGES ARE NOT COMPLETELY SEALED AND THE PRODUCT IS FALLING OUT"

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9354781 ↗
• MalfunctionDec 26, 2018Expiration Date Error

  IT WAS REPORTED WITH THE USE OF THE BD¿ SYRINGE SLIP TIP THERE WAS AN ISSUE WITH NO EXPIRATION DATE ON THE PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8197876 ↗

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-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-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-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-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-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-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-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