BD Luer-Lok 309581Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00382903095810), received between Nov 27, 2017 and Jun 3, 2026 — classified as 3 injuries, 71 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (30 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 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Leak/Splash

  IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL 25X1 RB HAD LEAKAGE. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CONTACT NAME: X CONTACT NUMBER: X CONTACT EMAIL (IF AVAILABLE): ITEM(S): 309581 LOT(S): N/A DATE INCIDENT OCCURRED (B)(6) 2026 WAS THE PATIENT IMPACTED? IF YES, DESCRIBE: YES, THE SYRINGES WERE LEAKING AND THE PATIENT WAS UNABLE TO USE THEM. IS A SAMPLE AVAILABLE?: NO CUSTOMER REQUEST?: REPLACEMENT SYRINGES LOT UNKNOWN (B)(6) 2026 VMF CUSTOMER DISCARDED MEDICATION WASTED BUT WAS ABLE TO ADMINISTER WITH ANOTHER SYRINGE. CUSTOMER PURCHASES FROM PHARMACY OF AMERICA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375292 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL 25X1 RB NEEDLE WAS BROKEN. COMPLAINT VIA PHONE. CASE DESCRIPTION: THE CLIENT STATES THAT HE USE THIS PRODUCT 52 TIMES A YEAR , 1 TIME AT EACH SATURDAY , AND HE RECEIVED SOME NEEDLES THAT WAS WITH MALFUNCTION , SOME OF THE NEEDLES BROKE ALONG AS USE IT , ONE TIME IT BROKE INSIDE OF HIS THIGH, AND THE CLIENT ALSO STATES THAT HE NOT HAVE BEEN GUIDED TO A HOSPITAL AND HE CAN SORT IT OUT BY HIMSELF CUSTOMER NAME: X, PHONE NUMBER: X, EMAIL: X, ADDRESS: (B)(6), PRODUCT: 3 ML BD LUER-LOK SYRINGE WITH ATTACHED NEEDLE 25 G X 1 IN. REF: 309581, LOT: 4345487.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25005789 ↗
• MalfunctionMar 25, 2026Nonstandard Device

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 25X1 RB BARREL / FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 309581 BATCH#: 5304809 VERBATIM: COMPLAINT VIA PHONE. PIR ATTACHED CASE DESCRIPTION: CUSTOMER STATES THAT WHEN SHE WAS GETTING READY TO DO A VACCINE SHE NOTICED THAT THE PLASTIC ON THE SYRINGE WAS NOT SEALED, THERE SEEMS TO BE SOME SORT OF GAP, AND BECAUSE OF THAT ALL OF THE PRODUCT LEAKED. PRODUCT: BD LUER-LOK SYRINGE WITH ATTACHED NEEDLE 25 G. REF#: (B)(4) LOT#: 5304809.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686438 ↗
• MalfunctionSep 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 25X1 RB HAD LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 309581. BATCH#: 2301213. POOR RESPONSE RATE WHEN I CONTACTED BD REGARDING MY COMPLAINT. I GIVE MOM HER B12 SHOTS. I MAKE SURE NEEDLE IS ON CORRECTLY. WHEN PUSHING PLUNGER B12 LEAKS OUT BETWEEN SYRINGE & THE NEEDLE INSERT, I GIVE MOM HER B12 SHOTS. I MAKE SURE NEEDLE IS ON CORRECTLY. WHEN PUSHING PLUNGER B12 LEAKS OUT BETWEEN SYRINGE & THE NEEDLE INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052295 ↗
• MalfunctionJul 9, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 25X1 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309581, BATCH#: 4345489. RCC RECEIVED A COMPLAINT VIA EMAIL. MATERIAL: 309581, BATCH: 4345489, WAS FOUND TO HAVE "GOOPY" STUFF STRINGING BETWEEN THE TOP INSIDE OF THE SYRINGE AND THE STOPPER. I WAS SENT PICTURES AND IT APPEARS TO BE EXCESS STOPPER LUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459396 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 25X1 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309581, BATCH #3354842. IT WAS REPORTED BY THE CUSTOMER THAT THE CUSTOMER STATED SHE INJECTS VITAMIN B12 AND THAT IT IS DIFFICULT TO DRAW UP MEDICATION WHEN THE MEDICATION WAS FINALLY DRAWN UP, WHILE SHE INJECTED, THE WHOLE MEDICATION SPILLED. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCT COMPLAINT - CUSTOMER CALLED AND STATED SHE CALLED SOMETIME IN 22ND DECEMBER AND SPOKE TO A (B)(4) WHO PROMISED CALLING HER BACK. CHECKED RECORDS TO SEE IF THERE WAS ANY CASE IN CUSTOMER NAME, NO CASE FOUND. CUSTOMER STATED SHE INJECTS VITAMIN B12 AND THAT IT IS DIFFICULT TO DRAW UP MEDICATION USING REF 309581 LOT 3354842, WHEN THE MEDICATION WAS FINALLY DRAWN UP, WHILE SHE INJECTED THE WHOLE MEDICATION SPILLED. NO PT HARM, SAMPLE IS AVAILABLE FOR RETURN. SEND CONTAINER FOR SAMPLE RETURN. CUSTOMER RESPONDED ON 09-MAY. TO WHOM IT MAY CONCERN: AS STATED TO CUSTOMER SERVICE REPRESENTATIVE, (B)(6) ON TUESDAY MAY 6, 2025: INITIALLY, I CONTACTED CUSTOMER SERVICE ON DECEMBER 23 2024 @ 2:22 PM AND I SPOKE WITH REGARDING THE M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092134 ↗
• MalfunctionMay 27, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 25X1 RB HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309581, BATCH #3354842. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCT COMPLAINT - CUSTOMER CALLED AND STATED SHE CALLED SOMETIME IN 22ND DECEMBER AND SPOKE TO A (B)(4) WHO PROMISED CALLING HER BACK. CHECKED RECORDS TO SEE IF THERE WAS ANY CASE IN CUSTOMER NAME, NO CASE FOUND. CUSTOMER STATED SHE INJECTS VITAMIN B12 AND THAT IT IS DIFFICULT TO DRAW UP MEDICATION USING REF 309581, LOT 3354842, WHEN THE MEDICATION WAS FINALLY DRAWN UP, WHILE SHE INJECTED THE WHOLE MEDICATION SPILLED. NO PT HARM, SAMPLE IS AVAILABLE FOR RETURN. SEND CONTAINER FOR SAMPLE RETURN. CUSTOMER RESPONDED ON 09-MAY. TO WHOM IT MAY CONCERN: AS STATED TO CUSTOMER SERVICE REPRESENTATIVE (B)(4) ON TUESDAY MAY 6, 2025: INITIALLY, I CONTACTED CUSTOMER SERVICE ON DECEMBER 23, 2024 @ 2:22 PM AND I SPOKE WITH **** REGARDING THE MATTER. I PUT THE DEFECTIVE PRODUCT ALONG WITH THE B12 CONTAINER IN A BAGGIE AS SOON AS I HAD ATTEMPTED MY INJECTION. UNDERSTANDABLY, IT IS THE VERY BUSY TIME OF THE YEAR FOR EVERYONE. WHEN I EXPLAINED THE SITUATION TO, SHE ASKED ME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091754 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 25X1 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #309581, BATCH #4137800. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ITEM(S): 309581, LOT(S):4137800, DATE INCIDENT OCCURRED: LATE LAST YEAR AND (B)(6) 2025. WAS THE PATIENT IMPACTED? YES. IF YES, DESCRIBE: PORTION OF THE NEEDLE POPPED OFF AND SPRAYED MEDICATION EVERYWHERE, WIFE WAS EXPOSED TO TESTOSTORONE AND WAS NOT ABLE TO TAKE THE MEDICATION. IS A SAMPLE AVAILABLE?: YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066971 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 25X1 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #309581. BATCH #4137800. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CONTACT NAME: CONTACT NUMBER: CONTACT EMAIL (IF AVAILABLE): ITEM(S): 309581 LOT(S): 4137800 DATE INCIDENT OCCURRED: LATE LAST YEAR AND (B)(6) 2025. WAS THE PATIENT IMPACTED? YES. IF YES, DESCRIBE: PORTION OF THE NEEDLE POPPED OFF AND SPRAYED MEDICATION EVERYWHERE, WIFE WAS EXPOSED TO TESTOSTERONE AND WAS NOT ABLE TO TAKE THE MEDICATION. IS A SAMPLE AVAILABLE? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066970 ↗
• MalfunctionApr 8, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21802400 ↗
• MalfunctionJan 16, 2025Volume Accuracy Problem; Volume Accuracy Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172525 ↗
• MalfunctionJan 7, 2025Connection Problem; Connection Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095956 ↗
• MalfunctionNov 27, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20790321 ↗
• MalfunctionOct 31, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577091 ↗
• MalfunctionSep 25, 2024Complete Blockage; Complete Blockage

  MATERIAL: 309581. BATCH#: 4052464. IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 25X1 RB NEEDLE WAS CLOGGED / BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CUSTOMER CALLED INTO THE EMBECTA QUEUE AND TRANSFERRED TO PRODUCT COMPLAINTS REGARDING A CLOGGED NEEDLE FOR REF 309581 LOT# 4052464.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306285 ↗
• MalfunctionAug 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MATERIAL#: 309581 BATCH#: UNKNOWN IT WAS REPORTED THAT THE BD LUER-LOK NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE RECEIVED A COMPLAINT ABOUT NEEDLES THAT ARE TOO FRAGILE, BEND, AND SEEM SOFT WHEN PIERCING THE STOPPER OF A VACCINE VIAL AND ON THE USER¿S ARM. THE OPERATOR TRIED TO PUSH ON THE NEEDLE WITH HIS HAND, AND IT DETACHED FROM THE PLASTIC TIP. NO INCIDENT REPORTED WITH THE USER. WE HAVE A SAMPLE OF THE SYRINGE WITH NEEDLE.¿ ADDITIONAL INFORMATION PROVIDED: 1. EVENT DATE: 03-07-2024. 2. BATCH NUMBER: 3244921. 3. NUMBER OF TIMES: TWICE AT FLEURY HOSPITAL AND A MONTH AGO AT (B)(6), REPRESENTATIVE HAVING ALREADY BEEN CONTACTED A MONTH AGO. 4. ADDRESS TO COLLECT SAMPLE: (B)(6). 5. NO INCIDENT OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20092086 ↗
• MalfunctionApr 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067919 ↗
• MalfunctionJan 17, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530782 ↗
• MalfunctionApr 21, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE THE NEEDLE WAS THE INCORRECT LENGTH. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAD PRODUCT 309581AND IT WAS SUPPOSED TO BE A 3ML 25G 1IN SYRINGE BUT WHEN THE CUSTOMER OPENS UP THE BOX IT WAS A HALF INCH NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16791607 ↗
• MalfunctionFeb 8, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE THE NEEDLE PULLED OUT OF THE HUB. THIS OCCURRED 2 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, WHEN REMOVING NEEDLE SHIELD, NEEDLE AND PART THAT HOLDS THE NEEDLE SEPARATED FROM SYRINGE. 2 SYRINGES AFFECTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16328345 ↗
• MalfunctionFeb 8, 2023Defective Device; Defective Device

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE THE NEEDLE PULLED OUT OF THE HUB. THIS OCCURRED 4 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED THAT THE NEEDLE IS COMING OUT OF THE HUB AND IT STAYED IN HIS SKIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 16321963 ↗
• MalfunctionFeb 8, 2023Break; Break

  IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE THE PLUNGER WAS DAMAGED. THIS OCCURRED 52 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RUBBER PART OF THE SYRINGE IS DETACHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16318534 ↗
• MalfunctionFeb 1, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE PROTECTIVE CAP OF THE BD LUER-LOK¿ TIP SYRINGE WITH THE BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE IS A FOREIGN OBJECT INSIDE THE PROTECTIVE CAP"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279442 ↗
• MalfunctionDec 16, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED BY THE CUSTOMER THAT 2 OF THE BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE WERE UNABLE TO DRAW MEDICATION, ONLY A FEW DROPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOUSE CALLED FOR ASSISTANCE WITH DRAWING HIS WIFE'S B-12. TWO ATTEMPTS WERE MADE TO DRAW MEDICATION, BUT IT WAS UNSUCCESSFUL. STATED, ONLY A FEW DROPS WENT INTO SYRINGES STATED, HE TRIED THE SYRINGE ON TWO DIFFERENT VIALS, BUT THE RESULT WAS THE SAME SPOUSE STATED, HE TRIED A FEW TIMES WITH THE SAME TWO SYRINGES BEFORE CALLING IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000649 ↗
• MalfunctionDec 5, 2022Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 1 IN. HAVE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATES THAT THESE ITEMS HAVE A DEFECT AND HAVE BROKEN OFF IN THE ARMS OF PATIENTS SPILLING APPROXIMATELY $200 WORTH OF VACCINE ON THE GROUND.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15921009 ↗

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-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-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-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-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-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-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