BD Luer-Lok 309632Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00382903096329), received between Nov 27, 2017 and Aug 5, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (5 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150035 ↗
• MalfunctionAug 5, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL W/NDL 21X1 RB LUER WAS CRACKED /DAMAGED /DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #:309632 BATCH#:5063045. RCC RECEIVED A COMPLAINT VIA EMAIL. " ON FRIDAY, (B)(6) 2025, A DOSE CONTAMINATION INCIDENT WAS REPORTED AT THE XXXXXXXXXXXXXXXXX. THE CONTAMINATION OCCURRED DUE TO A BROKEN SYRINGE, WHICH COMPROMISED THE CONNECTION AND CAUSED THE DOSE TO SPRAY UNEXPECTEDLY. AS A RESULT, THE PATIENT, STAFF, AND ROOM WERE CONTAMINATED. THE PATIENT WAS CLEANED, AND THE SITE RECEIVED A REPLACEMENT DOSE. THE PATIENT LATER RETURNED THE SAME DAY TO RECEIVE THE REPLACEMENT DOSE. THE ROOT CAUSE OF THIS ISSUE WAS THAT THE SYRINGE THAT WAS MISSING THE INNER PORTION OF THE MALE SLIP TIP. THIS MAY HAVE BROKEN OFF IN THE LUER CAP, OR HAVE BEEN MISSING DURING. DISPENSING." ITEM# 309632 LOT# 5063045.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716301 ↗
• MalfunctionJun 24, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL W/NDL 21X1 RB NEEDLE HUB HAD A HOLE WAS CRACKED / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309632 BATCH # 4325352. RCC RECEIVED A COMPLAINT VIA EMAIL. OPERATORS HAVE REPORTED THAT SOME OF THE NEEDLES FROM THIS LOT EITHER HAVE THE GREEN CAP NOT INTACT TO THE PLUNGER OR THERE IS DAMAGE TO THE GREEN PLASTIC HOUSING THE NEEDLE. PHOTOS ARE ATTACHED AS A REFERENCE. THE SITE WILL CONTINUE TO USE THIS LOT, HOWEVER, THE ONES AFFECTED WILL BE DISCARDED. PRODUCT#: 309632 LOT#: 4325352.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324574 ↗
• MalfunctionJun 10, 2025Crack; Crack

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL W/NDL 21X1 RB LUER WAS CRACKED / DAMAGED / DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 309632, BATCH#: 5063044. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE 5 ML LEUR LOCK SYRINGES WERE BREAKING AT THE LEUR TIP OF THE SYRINGE (THE HUB). THE INNER PIECE OF THE LEUR TIP WOULD BREAK/CRACK, PREVENTING SOME PATIENTS FROM BEING INJECTED WITH THEIR DOSES. ADDITIONALLY, OPERATORS DRAWING DOSES HAD MULTIPLE INSTANCES OF THIS OCCURRING PRIOR TO LEAVING THE PHARMACY. PRODUCT#: 309632, LOT#: 5063044. ADDITIONAL INFORMATION RECEIVED ON 4-JUNE-2025: EVENTS THAT AFFECTED PATIENTS' DOSES OCCURRED ON 16APR25 AND 23APR25. I DON'T HAVE SPECIFIC DATES FOR THE SYRINGES CAUGHT BEFORE THEY WERE DISPENSED. PLEASE SEE ATTACHED PHOTO OF PATIENT DOSE AFFECTED. TWO (2) PATIENTS WERE ABLE TO GET THEIR DOSES. ANOTHER HAD TO GET THEIR SCAN RESCHEDULED. NO PATIENT HARM/INJURY HAS BEEN REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180631 ↗
• MalfunctionJun 10, 2025Crack; Crack

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180627 ↗
• MalfunctionFeb 19, 2025Connection Problem; Connection Problem

  MATERIAL#: 309632, BATCH NUMBER#: 4066411. IT WAS REPORTED THAT THE BD LUER-LOK HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. THE SYRINGE NEEDLE IS FOUND TO NOT BE FULLY TWISTED INTO THE SECURED POSITION IN THE SYRINGE CAP. THE NEEDLE REQUIRES TWISTING WITH THE CAP TO SECURELY ATTACH IT TO THE BARREL. EVEN WITH TWISTING, THE NEEDLES MAY DETACH. THE CAP SOMETIMES DOES NOT EASILY LOCK, EVEN AFTER TAPPING IT CLOSED. ALSO, DUE TO THE NEEDLE NOT BEING FULLY INSERTED, THE SHIELD THAT CAPS THE NEEDLE OF THE 5ML BD SYRINGE (LOT: 4066411) WAS COMING OFF TOO EASILY. PHARMACIST WAS PLACING THE CAPPED SYRINGE FACING DOWN INTO A DOSE CALIBRATOR TO MEASURE DOSE ACTIVITY. UPON LIFTING THE SYRINGE OUT OF THE DOSE CALIBRATOR, THE CAP REMAINED STUCK INSIDE THE DOSE CALIBRATOR, EXPOSING THE NEEDLE OF THE SYRINGE. A SIMILAR OCCURRENCE WAS NOT PREVIOUSLY REPORTED FOR THIS LOT NUMBER. HOWEVER, THE PHARMACIST HAD THIS HAPPEN 3 TIMES IN A ROW. THE FAILURE RATE WAS 3 OUT OF 18. PRODUCT#: 309632, LOT#: 4066411. ADDITIONAL INFORMATION PROVIDED: 1. IT WAS MENTIONED "THE SYRINGE NEEDLE IS FOUND TO NOT BE FULLY TWISTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414744 ↗
• MalfunctionJan 29, 2025Crack; Crack

  NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21269963 ↗
• MalfunctionJan 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060532 ↗
• MalfunctionOct 29, 2024Volume Accuracy Problem; Volume Accuracy Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559435 ↗
• MalfunctionOct 22, 2024Volume Accuracy Problem; Volume Accuracy Problem

  MATERIAL: 309632. BATCH#: 3324994. IT WAS REPORTED THAT THE BD SYRINGE 5ML LL W/NDL 21X1 RB HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT 3 SYRINGES FROM THIS LOT HAVE BLACK MARK THAT GOES ALL AROUND THE SYRINGE. APPEARS TO BE ON THE OUTSIDE OF THE SYRINGES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. 3 SYRINGES FROM THIS LOT HAVE BLACK MARK THAT GOES ALL AROUND THE SYRINGE. APPEARS TO BE ON THE OUTSIDE OF THE SYRINGES. PRODUCT#: 309632, LOT#: 3324994. CUSTOMER RESPONSE: 1.DATE OF EVENT: 09/10/2024. 2.THE SITE NO LONGER HAS THE 5ML SYRINGES. 3.NO ADVERSE EVENTS OF SERIOUS INJURY REPORTED TO PATIENT OF HEALTHCARE PROFESSIONALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20511276 ↗
• MalfunctionFeb 20, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD LUER-LOK CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINANT (HAIR OR PLUNGER SHRED?) DISCOVERED IN BARREL OF 5ML SYRINGE DURING INSPECTION PRIOR TO COMPOUNDING. SYRINGE WAS QUARANTINED AND NOT USED FOR COMPOUNDING THE DOSE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744478 ↗
• MalfunctionNov 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18156922 ↗
• MalfunctionDec 12, 2022Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT THE BD LUER-LOCK¿ SYRINGE WITH NEEDLE LEAKED AND A CRACK WAS FOUND IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE RECEIVED A COMPLAINT FROM ONE OF OUR CUSTOMERS STATING THAT A BD SYRINGE THEY RECEIVED A DOSE IN WAS LEAKING. THE SYRINGE WAS RETURNED TO THE PHARMACY AND A CRACK ON THE SIDE OF THE SYRINGE WAS FOUND. DATE OF EVENT WAS (B)(6) 2022. THE PROCEDURE WAS ABLE TO BE COMPLETED ALTHOUGH SOME PRODUCT WAS LOST DUE TO THE LEAK. WE ARE NOT AWARE OF ANY ADVERSE EFFECTS ON THE PATIENT. THE SYRINGE WAS DISPOSED OF AS MEDICAL WASTE BECAUSE THE SYRINGE IS BIOHAZARDOUS WASTE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15965181 ↗
• MalfunctionAug 30, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE EXPERIENCED BROKEN CAP WITH ONE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER ONE SYRINGE WITH BROKEN CAP OBSERVED ON (B)(6) 2022 AND CAUSED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15325498 ↗
• MalfunctionJun 20, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE EXPERIENCED INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BOX LABELING SIZE DOES NOT MATCH WHAT IS ON THE STICKER ATTACHED TO THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14746701 ↗
• MalfunctionMar 25, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT SYRINGE 5ML LL W/NDL 21X1 RB HAD NO SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309632, BATCH NO: 0209102.   IT WAS REPORTED THAT THERE WERE NO MARKINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572606 ↗
• MalfunctionJan 19, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE SYRINGE 5ML LL W/NDL 21X1 RB HAD NO SCALE MARKINGS ON IT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 5TH OF 7 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO WRITING ON SYRINGES."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11198425 ↗
• MalfunctionNov 18, 2020Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT THE SYRINGE 5ML LL W/NDL 21X1 RB PLUNGER WAS SEATED INCORRECTLY AND DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATED THAT THEY HAVE HAD THE SAME ISSUE WITH TWO DIFFERENT SYRINGES. CUSTOMER STATED THAT THE PLUNGER IS NOT SEATED CORRECTLY AND THAT THERE IS AN ISSUE WITH THE PLUNGER'S CIRCUMFERENCE. FOR MATERIAL 309632; DOE (B)(6) 2020. BEFORE USE, NO ADVERSE EVENTS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10860770 ↗
• MalfunctionSep 1, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE 5ML LL W/NDL 21X1 RB EXPERIENCED A BRON NEEDLE AND A NEEDLE THAT WAS LOOSE/PULLED OUT OF HUB. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309632, BATCH NO: UNKNOWN. 2020-08-06: RECEIVED VOICEMAIL FROM CONSUMER WITH SYRINGE COMPLAINT. CONSUMER STATED HE HAD A .5 ML SYRINGE THAT CAME APART AND HE LOST AN ENTIRE VIAL OF MEDICINE DUE TO THIS. LG FROM PHONE CALL: CONSUMER RETURNED PHONE CALL FROM VOICEMAIL HE RECEIVED FROM REP. STATED THE NEEDLE BROKE OFF OF ONE OF HIS SYRINGES WHEN DRAWING UP HIS MEDICATION AND IT WENT INTO THE MEDICATION VIAL. STATED HE LOST A WHOLE VIAL OF MEDICATION DUE TO THIS. STATED HE HAS ALSO EXPERIENCED NEEDLE SEPARATION TOWARDS THE END OF HIS INJECTIONS. STATED THIS DOESN'T HAPPEN A LOT BUT HAS HAPPENED ABOUT 2-3 TIMES. LG PRODUCT COMPLAINTS RECEIVED A CALL FROM A CONSUMER. HE MENTIONED THAT HIS LUER-LOK¿ TIP SYRINGE (309632) FELL APART AS HE WAS ABOUT TO INJECT HIMSELF WITH MEDICINE AND HIS MEDICINE SPILLED ON (B)(6) 2020. HE WAS NOT HARMED IN ANY SORT OF WAY SINCE THIS OCCURRED RIGHT BEFORE INJECTION. HE SPOKE TO A BD REP AND THEY SAID THEY WOULD REPLACE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10476987 ↗
• MalfunctionNov 13, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ DETACHABLE NEEDLE HAD SEPARATED FROM THE BD¿ TUBERCULIN SYRINGE AND REMAINED INSIDE THE CAP WHEN REMOVING IT DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED WHEN SHE REMOVES THE CAP FROM THE NEEDLE, THE NEEDLE AND HUB REMAINS INSIDE THE CAP. SHE USES THE PLYER TO REMOVE THE NEEDLE. SHE USES TWICE A DAY, SHE HAS ABOUT 14 NEEDLE DETACHED FROM THE HUB REMAINED IN THE NEEDLE SHIELD."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9315376 ↗
• MalfunctionJun 4, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE HAD STERILITY ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309632, BATCH NO.: 9008885. CUSTOMER WOULD LIKE TO KNOW IF THERE HAVE BEEN ANY COMPLAINTS, FIELD ISSUES, OR MANUFACTURING DEVIATIONS AS THERE WAS A STERILITY POSITIVE FOR BACTERIA. VERBATIM: AS PART OF AN ONGOING INVESTIGATION INTO A STERILITY POSITIVE, WE ARE CONTACTING THE SUPPLIER OF STERILE MATERIALS USED IN OUR PROCESS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8667306 ↗
• MalfunctionMay 16, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT THERE WAS BLACK MATERIAL FOUND ON THE SYRINGE. THOUGHT I WOULD PASS ALONG A PHOTO OF A 5 ML BD SYRINGE ISSUE WE FOUND TODAY. ONE OF OUR NPT¿S BROUGHT IT TO MY ATTENTION TO FORWARD ALONG. I CAN¿T TELL WHAT THE BLACK MATERIAL IS, INK OR RUBBER? BUT IT¿S ALL OVER THE INTERIOR AND EXTERIOR OF THE SYRINGE WITHIN THE WRAPPER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8617493 ↗
• MalfunctionNov 26, 2018Contamination /Decontamination Problem

  IT WAS REPORTED THAT BEFORE USE OF THE BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE HAD BLACK SPOTS ON THE SEAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8103006 ↗
• MalfunctionJan 26, 2018Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE SCALE MARKINGS OF A BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE WERE MISSING, FOUND BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7221400 ↗
• MalfunctionDec 27, 2017Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE SCALE MARKINGS ON A BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE WERE NOT MARKED BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7148155 ↗

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-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-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-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