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BD Luer-Lok 309580Recalls & reported problems

Becton, Dickinson And Company · SYRINGE 3ML LL W/NDL 18X1-1/2 RB · Class 2

All models of BD Luer-Lok (48)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This BD Luer-Lok syringe is a 3mL syringe sold with a needle. The 23 reports mostly describe leaking and needles that were hard to twist on or off, sometimes wasting medication, with no deaths and no injuries mentioned. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
23
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00382903095803), received between Oct 26, 2017 and May 26, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 4 reportsApr 2026: 1 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Leak/Splash7
  • Device Contamination with Chemical or Other Material6
  • Device Markings/Labelling Problem2
  • Connection Problem1
  • Contamination /Decontamination Problem1
  • Defective Component1
  • Detachment of Device or Device Component1
  • Device Contaminated at the User Facility1

Patient problems

  • No Clinical Signs, Symptoms or Conditions16
  • No Known Impact Or Consequence To Patient3
  • No Consequences Or Impact To Patient2
  • No Patient Involvement2

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 26, 2026

    STAFF HAVE REPORTED 2 INCIDENTS WHERE THEY WERE UNABLE TO EASILY RELEASE THE NEEDLE FROM OUR 3ML SYRINGES WITH 18G 1 1/2". STAFF STATED THEY ARE UNABLE TO TWIST THE NEEDLE OFF OF THE SYRINGE AFTER DRAWING UP THE MEDICATION. THE 2ND TIME IT HAPPENED WE WERE ABLE TO APPLY EXTRA PRESSURE AND RELEASE IT, BUT IT WAS MORE DIFFICULT TO UNSCREW THAN THEY ARE USED TO. BD PLASTIPAK, LEUR-LOK LOT # 6058491.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25276940 ↗
  • MalfunctionApr 1, 2026Leak/Splash

    NO ADDITIONAL INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24761400 ↗
  • MalfunctionMar 24, 2026Leak/Splash

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 18X1-1/2 RB HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 309580, BATCH#: 5338599, 5353717. IT WAS REPORTED BY THE CUSTOMER THAT CANNOT TWIST THE NEEDLE OF TO CONNECT INTO HER LINE, AND ALSO HER MEDICATION LEAK IT FROM THE BOTTLE MAKING IT CONTAMINATED. HELLO, ATTACHED YOU WILL FIND IMAGES OF THE LOT AND REFERENCE NUMBERS OF THE SYRINGES THAT HAVE BEEN DEFECTIVE IN THE LAST FEW DAYS. I WILL ALSO SUPPLY YOU WITH THAT INFORMATION VIA TEXT IN THIS EMAIL. I DID NOT SAVE ANY OF THE BAD SYRINGES FOR INVESTIGATION BECAUSE I COMPLETELY FORGOT TO. I GIVE MYSELF INJECTIONS AT HOME, SO THESE CIRCUMSTANCES DID NOT HAPPEN AT A HOSPITAL OR CLINIC AND THERE WERE NO CASES REPORTED BESIDES MY CALLING UP BD TO INFORM YOU OF WHAT HAS BEEN OCCURRING FOR QUITE SOME TIME. SYRINGES THAT HAVE BEEN DEFECTIVE WITHIN THE LAST FEW DAYS: LOT: 5338599, REF 309580, LOT: 5338599, REF 309580, LOT: 5353717, REF 309580, LOT: 5338599, REF 309580, LOT: 5338599, REF 309580. ADDITIONAL INFORMATION PROVIDED: A COUPLE OF THEM WERE DEFECTIVE ON THE SAME DAY. I AM THE PATIENT AND AM VERY SKILLED AT SELF-INJECTION AND HAVE BEEN EXPERIEN

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24681984 ↗
  • MalfunctionMar 24, 2026Leak/Splash

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 18X1-1/2 RB HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 309580 BATCH#: 5338599, 5353717. IT WAS REPORTED BY THE CUSTOMER THAT CANNOT TWIST THE NEEDLE OF TO CONNECT INTO HER LINE , AND ALSO HER MEDICATION LEAK IT FROM THE BOTTLE MAKING IT CONTAMINATED. VERBATIM: HELLO, ATTACHED YOU WILL FIND IMAGES OF THE LOT AND REFERENCE NUMBERS OF THE SYRINGES THAT HAVE BEEN DEFECTIVE IN THE LAST FEW DAYS. I WILL ALSO SUPPLY YOU WITH THAT INFORMATION VIA TEXT IN THIS EMAIL. I DID NOT SAVE ANY OF THE BAD SYRINGES FOR INVESTIGATION BECAUSE I COMPLETELY FORGOT TO. I GIVE MYSELF INJECTIONS AT HOME, SO THESE CIRCUMSTANCES DID NOT HAPPEN AT A HOSPITAL OR CLINIC AND THERE WERE NO CASES REPORTED BESIDES MY CALLING UP BD TO INFORM YOU OF WHAT HAS BEEN OCCURRING FOR QUITE SOME TIME. SYRINGES THAT HAVE BEEN DEFECTIVE WITHIN THE LAST FEW DAYS: LOT 5338599 REF 309580 LOT 5338599 REF 309580 LOT 5353717 REF 309580 LOT 5338599 REF 309580 LOT 5338599 REF 309580. ADDITIONAL INFORMATION PROVIDED: A COUPLE OF THEM WERE DEFECTIVE ON THE SAME DAY. I AM THE PATIENT AND AM VERY SKILLED AT SELF-INJECTION AND HAVE BEEN EXPERIENCING

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24681755 ↗
  • MalfunctionMar 20, 2026Leak/Splash

    IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL 18X1-1/2 RB DEMONSTRATED A LEAK. VERBATIM: CASE DESCRIPTION: THE CUSTOMER STATES ONCE THE MEDICATION IS PULLED , THE CUSTOMER CANNOT TWIST THE NEEDLE OF TO CONNECT INTO HER LINE , AND ALSO HER MEDICATION LEAK IT FROM THE BOTTLE MAKING IT CONTAMINATED , BECOMING UNABLE TO USE ! ALSO THE CUSTOMER STATES THAT SHE IS NOT BEING ABLE TO RECEIVE HER MEDICATION BECAUSE OF THE PRODUCT ERROR . PHONE NUMBER EMAIL: ADDRESS: PRODUCT: REF#: 309580 LOT#: 5338599 THE CLIENT ALSO STATES , ONCE THE COMPLAINT IS CONFIRMED SHE WOULD LIKE A REPLACEMENT FOR THE PRODUCTS ! ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS.: YES. WHEN THE SYRINGE DOES NOT TWIST OF OR PRODUCT LEAKS OUT OF THE BOTTOM, I AM UNABLE TO USE THAT DOSE OF MEDICATION MAKING ME TO HAVE TO WASTE AND DISCARD IT. I HAVE A PORT AND THE NEEDLE IS USED TO JUST PULL UP MEDS. IF I CANNOT TWIST THE CAP/NEEDLE OFF, I AM UNABLE TO ATTACH THE SYRINGE TO MY PORT. WHEN THE MEDICATION LEAKS OUT OF THE BOTTOM, IT THEN BECOMES CONTAMINATED WHICH CAN LEAD TO A SEVERE BLOOD INFECTION. EITHER WAY, I AM LOSING DOSES OF MEDICATION. CAN YOU P

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24648255 ↗
  • MalfunctionMar 20, 2026Connection Problem

    IT WAS REPORTED THAT BD SYRINGE 3 ML LL W/NDL 18X1-1/2 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. VERBATIM: CASE DESCRIPTION: THE CUSTOMER STATES ONCE THE MEDICATION IS PULLED, THE CUSTOMER CANNOT TWIST THE NEEDLE OF TO CONNECT INTO HER LINE, AND ALSO HER MEDICATION LEAK IT FROM THE BOTTLE MAKING IT CONTAMINATED, BECOMING UNABLE TO USE! ALSO, THE CUSTOMER STATES THAT SHE IS NOT BEING ABLE TO RECEIVE HER MEDICATION BECAUSE OF THE PRODUCT ERROR REF#: 309580. LOT#: 5338599. THE CLIENT ALSO STATES, ONCE THE COMPLAINT IS CONFIRMED SHE WOULD LIKE A REPLACEMENT FOR THE PRODUCTS! ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS: YES. WHEN THE SYRINGE DOES NOT TWIST OF OR PRODUCT LEAKS OUT OF THE BOTTOM, I AM UNABLE TO USE THAT DOSE OF MEDICATION MAKING ME TO HAVE TO WASTE AND DISCARD IT. I HAVE A PORT AND THE NEEDLE IS USED TO JUST PULL UP MEDS. IF I CANNOT TWIST THE CAP/NEEDLE OFF, I AM UNABLE TO ATTACH THE SYRINGE TO MY PORT. WHEN THE MEDICATION LEAKS OUT OF THE BOTTOM, IT THEN BECOMES CONTAMINATED WHICH CAN LEAD TO A SEVERE BLOOD INFECTION. EITHER WAY, I AM LOSING DOSES OF MEDICATION. CAN YOU PLEASE PROVIDE AN EXACT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24648254 ↗
  • MalfunctionNov 25, 2025Packaging Problem; Packaging Problem

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 18X1-1/2 RB HAD A PRIMARY PACKAGE INTEGRITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #309628 BATCH #5255357 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. MY NAME IS *** AND I WORK FOR AN FDA REGULATED PHASE 1 CLEAN ROOM MANUFACTURING FACILITY. I ORDERED TWO BOXES OF 1ML LUER-LOK SYRINGES THROUGH *****. ONE OF THE BOXES HAD DAMAGED SYRINGES INSIDE AND LOOKED LIKE THE BOX WAS NOT FILLED CORRECTLY. I HAVE ATTACHED THE PHOTO I TOOK UPON OPENING THE BOX SO YOU CAN SEE HOW CHAOTIC THE SYRINGES WERE PLACED IN THE BOX. I VISUALLY INSPECTED THE TOP 30 OR SO TO MAKE SURE THE OUTER WRAPPING WASN¿T COMPROMISED. THE REMAINING INVENTORY WAS LAID FLAT AND NOT DISORGANIZED. FORTUNATELY, I ONLY FOUND 2 OUT OF 30 THAT WERE DAMAGED. I HAVE NOT ENCOUNTERED THIS ISSUE BEFORE SO I THINK IT IS AN ISOLATED INCIDENT, NONE THE LESS I WANTED TO LET YOUR COMPANY KNOW JUST IN CASE THIS WASN¿T THE ONLY CASE INVOLVED. I WAS UNABLE TO FIND A QUALITY CONTROL EMAIL TO FORWARD THIS INFORMATION TO FOR DOCUMENTING. WOULD YOU PLEASE PROVIDE ME WITH AN EMAIL I CAN SENT THIS TO? SYRINGE, LUER-LOK 1 ML, CAT# 309628, LOT # 5255357, EXP

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23645464 ↗
  • MalfunctionOct 31, 2025Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 18X1-1/2 RB HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309580. BATCH#: 3355781. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ITEM - 309580. LOT - 3355781. PO - (B)(4). ISSUE - SYRINGES ARE LEAKING AT MIDWAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23442235 ↗
  • MalfunctionApr 16, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21849369 ↗
  • MalfunctionDec 17, 2024Defective Component; Defective Component

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20954251 ↗
  • MalfunctionNov 14, 2024Device 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 20684369 ↗
  • MalfunctionFeb 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE STOPPER SEPARATED FROM THE PLUNGER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN DRAWING UP MEDICATION PROGESTERONE. AUTO MEDICS OF IVF TREATMENT CUSTOMER STATES THAT A PIECE OF THE RUBBER STOPPER SEPARATED FROM THE DEVICE AND CONTAMINATED THE MEDICATION." RESIDENT CONSUMER: (B)(6). PHARMACY: (B)(6). DOE: 01FEB2024. ISSUE: WHEN DRAWING UP MEDICATION PROGESTERONE BRAND: AUTO MEDICS OF IVF TREATMENT CUSTOMER STATES THAT A PIECE OF THE RUBBER STOPPER SEPARATED FROM THE DEVICE AND CONTAMINATED THE MEDICATION. REF: (B)(4). LOT: 3300752. PT HARM: NO BUT DID LOOSE MEDICATION DOSAGE, HAD TO ORDER NEW DOSAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18707873 ↗
  • MalfunctionJun 10, 2022Device Contaminated at the User Facility; Device Contaminated at the User Facility

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 18 G FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THERE WAS A RUBBER ON THE NEEDLE OF A SYRINGE THAT WAS INSERTED INTO A VIAL. THERE WAS A RUBBER ON THE NEEDLE OF A SYRINGE THAT WAS INSERTED INTO A VIAL. I NOTICED THE RUBBER ON THE NEEDLE WHEN I WAS EXTRACTING THE PRODUCT, AND WHEN I PULLED OUT THE NEEDLE THE RUBBER REMAINED IN THE VIAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14651826 ↗
  • MalfunctionFeb 25, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 18 G X 1 1/2 IN., STERILE FOREIGN MATTER WAS FOUND IN THE BARREL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:309580 BATCH NO: 1081263.   IT WAS REPORTED BY THE CONSUMER OILY SUBSTANCE IN THE BARREL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13598674 ↗
  • MalfunctionNov 23, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH NEEDLE PLUNGER BENT EASILY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATED THAT THE 2ND BOX HAS SOME SYRINGES THAT ARE TOO EASY TO BEND."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12866470 ↗
  • MalfunctionJun 3, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 18X1-1/2 RB WAS MISSING THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISSING EXPIRATION DATE. VERBATIM: PHARMACY REPORTED FOUND OPENED BOXES OF PRODUCT THAT APPEARED TO BE EXPIRED. AFTER REVIEW OF LOT #S AND ITEM #S THEY ARE EXPIRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11931451 ↗
  • MalfunctionAug 26, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED THAT THE EXPIRATION DATE WAS MISSING FROM THE BD LUER-LOK¿ SYRINGE WITH NEEDLE BOX BEFORE USE. THIS OCCURRED AN UNSPECIFIED NUMBER OF TIMES IN LOT 3086255 AND AN UNSPECIFIED LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST HAS MULTIPLE BOXES THAT DO NOT HAVE THE EXPIRATION DATE ON THEM SO SHE WOULD LIKE TO KNOW WHAT IT IS."

    Patient problems: No Patient Involvement

    MAUDE report 10454585 ↗
  • MalfunctionJun 10, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL 18X1-1/2 RB HAD FOREIGN MATTER INSIDE THE BARREL OF THE SYRINGE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309580 BATCH NO.: 0077232. IT WAS REPORTED THAT WATER WAS FOUND INSIDE THE BARREL OF THE SYRINGE AND ALSO LIQUID WAS FOUND IN THE SEALED PACKAGING.

    Patient problems: No Patient Involvement

    MAUDE report 10141342 ↗
  • MalfunctionMar 2, 2020Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE ATTACHED NEEDLE BENT AND SEPARATED FROM THE BD LUER-LOK¿ SYRINGE DURING USE, AFTER DRAWING UP MEDICATION. THIS CAUSED THE MEDICINE TO LEAK OUT BEFORE THE SHOT COULD BE ADMINISTERED. THE MEDICATION WAS BEING USED FOR A PREGNANCY, AND THE FULL DOSE WAS NOT RECEIVED AS A RESULT OF THE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOUSE STATED, HE WAS ABLE TO DRAW THE MEDICATION, BUT IT STARTED TO LEAK BEFORE HE COULD ADMINISTER THE SHOT STATED, THE MEDICATION IS FOR HIS WIFE'S PREGNANCY STATED, A PIECE OF THE SYRINGE SNAPPED OFF? STATED, WAS NOT ABLE TO USE MEDICATION THAT WAS DRAWN UP AND AS A RESULT, HE HAD TO PAY OUT OF POCKET FOR MORE MEDICATION FOR HIS WIFE." "PRODUCT NUMBER 309580. HE STATED HE ADMINISTERS THE MEDICATION TO HIS WIFE, AND IN THIS PARTICULAR INCIDENT, HE STATED THE NEEDLE BENT AND GOT SEPARATED FROM THE PLUNGER RESULTING IN THE MEDICATION LEAKING OUT AND HIS WIFE NOT GETTING THE FULL AMOUNT SHE NEEDED. LOT NUMBER IS UNKNOWN AND THE DATE OF EVENT HE PROVIDED IS 12/19/19."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9776124 ↗
  • MalfunctionJun 25, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT A CLEAR, STICKY FOREIGN MATTER WAS NOTICED INSIDE THE BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE BEFORE BEING USED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HEALTH PROFESSIONAL AT CLINIC WAS ABOUT TO ADMINISTER MEDICATION WHEN NOTICED A CLEAR, STICKY GLUE-LIKE LIQUID INSIDE OF THE SYRINGE."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8730843 ↗
  • MalfunctionMar 27, 2018Unsealed Device Packaging

    IT WAS REPORTED BEFORE USE OF THE BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE ¿THE PRODUCTS WERE NOT PROPERLY SEALED.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7375392 ↗
  • MalfunctionFeb 12, 2018Out-Of-Box Failure; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT FOREIGN MATTER DESCRIBED AS A ¿BLACK FLAKE¿ WAS FOUND IN A BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE BEFORE USE. THERE WAS NO REPORT OF EXPOSURE INJURY OR MEDICAL INTERVENTIONS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7263435 ↗
  • MalfunctionOct 26, 2017Device Packaging Compromised; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT 3 ML BD LUER-LOK" SYRINGE WITH ATTACHED NEEDLE 18 G X 1 1/2 IN APPEARED TO HAVE MOLD INSIDE THE SEALED PACKAGE. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6979693 ↗

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-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-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-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-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-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-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

Other Syringe, piston devices

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Sources and updates

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