BD Luer-Lok 309604Recalls & reported problems
Becton, Dickinson And Company · Syringe 10ml LL · Class 2
Quick summary
This BD Luer-Lok syringe is a 10 mL locking-tip syringe. Reports mostly describe cracked or leaking syringes, poor printing and foreign matter found before use, and occasional volume-marking problems. There are 103 adverse event reports naming its identifier, including 1 injury and no deaths. 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
- 103
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 30382903096047), received between Sep 23, 2016 and Apr 28, 2026 — classified as 1 injury, 102 malfunctions.
The most frequently reported specific device problem is “Break” (17 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break17
- Leak/Splash17
- Device Contamination with Chemical or Other Material13
- Device Markings/Labelling Problem8
- Crack7
- Defective Component7
- Volume Accuracy Problem7
- Fluid/Blood Leak6
Patient problems
- No Clinical Signs, Symptoms or Conditions60
- No Known Impact Or Consequence To Patient28
- No Consequences Or Impact To Patient10
- No Patient Involvement5
- No Information2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 103 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT THE BD SYRINGE 10ML LL HAD FORIENG MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A COMPLAINT ABOUT POOR PRINTING & FOREIGN MATTER CONTAMINATION FOUND BEFORE USE. IT WAS REPORTED THAT DURING THE VISUAL INSPECTION WITHIN THE PROCESS, CUSTOMER IDENTIFIED NONCONFORMING PRODUCTS. THE DEFECT IS INK SMUDGING. THIS IS DUE TO POOR PRINTING AND FOREIGN MATTER CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25020060 ↗MalfunctionSep 18, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE BD SYRINGE 10ML LL HAD FORIENG MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A COMPLAINT ABOUT POOR PRINTING & FOREIGN MATTER CONTAMINATION FOUND BEFORE USE. IT WAS REPORTED THAT DURING THE VISUAL INSPECTION WITHIN THE PROCESS, CUSTOMER IDENTIFIED NONCONFORMING PRODUCTS. THE DEFECT IS INK SMUDGING. THIS IS DUE TO POOR PRINTING AND FOREIGN MATTER CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23092003 ↗MalfunctionNov 24, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20767563 ↗MalfunctionOct 31, 2024Defective Component; Defective Component
IT WAS REPORTED THAT THE BD LUER-LOK STOPPER WAS DEFECTIVE / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM JAPANESE TO ENGLISH: IT WAS REPORTED THAT BLOOD LEAKAGE OCCURRED DURING USE DUE TO DEFORMED GASKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20583298 ↗MalfunctionOct 23, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD LUER-LOK HAD LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM JAPANESE TO ENGLISH: DURING LIPOSUCTION SURGERY, CUSTOMER CONNECTED A CANNULA (MADE BY COLEMAN) TO THIS SYRINGE AND ASPIRATED, BUT THE FAT WOULD NOT ASPIRATE. THEY SUSPECTED THAT THE CAUSE OF THE FAT NOT ASPIRATING WAS A LEAK IN THE CONNECTION, SO THEY APPLIED GEL AROUND THE CONNECTION (TO FILL THE LEAK PART), AND WHEN THEY ASPIRATED AGAIN, THEY ARE ABLE TO ASPIRATE. CUSTOMER WOULD LIKE US TO INVESTIGATE THE PRODUCT FOR ANY LEAKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20518907 ↗MalfunctionSep 30, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE BD LUER-LOK STOPPER SEPARATED FROM PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM JAPANESE TO ENGLISH: IT WAS REPORTED THAT DURING THE INSPECTION OF THE PRODUCTS AT TOGO MEDIKIT, SMEAR/MISSING SCALE, DIRT, DISLODGED GASKET, DAMAGE, BURR WERE DETECTED BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20340226 ↗MalfunctionSep 30, 2024Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT THE BD LUER-LOK HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM JAPANESE TO ENGLISH: IT WAS REPORTED THAT DURING THE INSPECTION OF THE PRODUCTS AT TOGO MEDIKIT, SMEAR/MISSING SCALE, DIRT, DISLODGED GASKET, DAMAGE, BURR WERE DETECTED BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20338898 ↗MalfunctionSep 30, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM JAPANESE TO ENGLISH: IT WAS REPORTED THAT DURING THE INSPECTION OF THE PRODUCTS AT TOGO MEDIKIT, SMEAR/MISSING SCALE, DIRT, DISLODGED GASKET, DAMAGE, BURR WERE DETECTED BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20337171 ↗MalfunctionJul 16, 2024Crack; Crack
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19755828 ↗MalfunctionJun 9, 2024Missing Information; Missing Information
MATERIAL #: 309604. BATCH#: UNKNOWN. IT WAS REPORTED THAT THE BD LUER-LOK PACKAGING HAD LABEL CONTENT MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE SEVERAL SYRINGES WITH NO EXPIRATION DATE ON THE PACKAGE. I WAS HOPING YOU COULD HELP US FIGURE IT OUT. THE NUMBER UNDER THE BARCODING IS (B)(6). PRODUCT NUMBER - 309604.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19495297 ↗MalfunctionMar 19, 2024Volume Accuracy Problem; Volume Accuracy Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18935398 ↗MalfunctionFeb 22, 2024Defective Device; Defective Device
IT WAS REPORTED THAT THE BD LUER-LOK BARREL/FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM JAPANESE TO ENGLISH: "IT WAS REPORTED THAT DEFORMATION OF THE SYRINGE TIP WAS OBSERVED DURING INSPECTION AT TOGO MEDIKIT (1 CASE). SEVEN OTHER DEFECTIVE PRODUCTS WERE REPORTED." 41 SAMPLES WERE RETURNED. BDJ CONFIRMED 1 LUER DEFORMED, 2 BARREL DEFORMED, 17 EMBEDDED FM/BLACK SPOTS, 2 STOPPER DEFORMED AND 19 SCALE MARKING BLURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18762995 ↗MalfunctionFeb 21, 2024Defective Component; Defective Component
IT WAS REPORTED THAT THE BD LUER-LOK LUER WAS CRACKED/DAMAGED/DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM JAPANESE TO ENGLISH: "IT WAS REPORTED THAT DEFORMATION OF THE SYRINGE TIP WAS OBSERVED DURING INSPECTION AT TOGO MEDIKIT (1 CASE). SEVEN OTHER DEFECTIVE PRODUCTS WERE REPORTED." 41 SAMPLES WERE RETURNED. BDJ CONFIRMED 1 LUER DEFORMED, 2 BARREL DEFORMED, 17 EMBEDDED FM/BLACK SPOTS, 2 STOPPER DEFORMED AND 19 SCALE MARKING BLURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18754623 ↗MalfunctionFeb 21, 2024Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT THE BD LUER-LOK LUER WAS CRACKED/DAMAGED/DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM JAPANESE TO ENGLISH: "IT WAS REPORTED THAT DEFORMATION OF THE SYRINGE TIP WAS OBSERVED DURING INSPECTION AT TOGO MEDIKIT (1 CASE). SEVEN OTHER DEFECTIVE PRODUCTS WERE REPORTED." (B)(4) SAMPLES WERE RETURNED. BDJ CONFIRMED (B)(4) LUER DEFORMED, (B)(4) BARREL DEFORMED, (B)(4) EMBEDDED FM/BLACK SPOTS, (B)(4) STOPPER DEFORMED AND (B)(4) SCALE MARKING BLURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18754622 ↗MalfunctionFeb 21, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18754621 ↗MalfunctionFeb 21, 2024Crack; Crack
IT WAS REPORTED THAT THE BD LUER-LOK LUER WAS CRACKED/DAMAGED/DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM JAPANESE TO ENGLISH: "IT WAS REPORTED THAT DEFORMATION OF THE SYRINGE TIP WAS OBSERVED DURING INSPECTION AT TOGO MEDIKIT (1 CASE). SEVEN OTHER DEFECTIVE PRODUCTS WERE REPORTED." 41 SAMPLES WERE RETURNED. BDJ CONFIRMED 1 LUER DEFORMED, 2 BARREL DEFORMED, 17 EMBEDDED FM/BLACK SPOTS, 2 STOPPER DEFORMED AND 19 SCALE MARKING BLURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18754067 ↗MalfunctionDec 10, 2023Device 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 18298464 ↗MalfunctionSep 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT 6 BD LUER-LOK¿ TIP SYRINGES HAD EMBEDDED FOREIGN MATTER IN THEM. THIS COMPLAINT WAS CREATED TO CAPTURE THE 5TH OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS REPORT IS ABOUT FADED PRINTING. THE PRINTING ON THE SYRINGE WAS FADED." VIA BDJ INVESTIGATION TEAM: "BDJ RECEIVED 122 UNUSED SAMPLS. AFTER OBSERVATION, CATEGORIZED THE FOLLOWING DEFECTS. 1. UNUSED PRINT DEFECTS 87. 2. UNOPENED PRINT DEFECTS (LOT#1312426) 3. 3. STAINS 12 4. PLUNGER DEFORMATION 5. 5. SCRATCHES OR OTHER DAMAGE 9. 6. EMBEDDED FOREIGN MATTER".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17737922 ↗MalfunctionSep 13, 2023Defective Component; Defective Component
IT WAS REPORTED THAT 9 BD LUER-LOK¿ TIP SYRINGES WERE DAMAGED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS REPORT IS ABOUT FADED PRINTING. THE PRINTING ON THE SYRINGE WAS FADED." VIA BDJ INVESTIGATION TEAM: "BDJ RECEIVED 122 UNUSED SAMPLS. AFTER OBSERVATION, CATEGORIZED THE FOLLOWING DEFECTS: 1. UNUSED PRINT DEFECTS 87. 2. UNOPENED PRINT DEFECTS (LOT#1312426) 3. 3. STAINS 12. 4. PLUNGER DEFORMATION 5. 5. SCRATCHES OR OTHER DAMAGE 9. 6. EMBEDDED FOREIGN MATTER".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17737920 ↗MalfunctionSep 13, 2023Break; Defective Component; Break; Defective Component
IT WAS REPORTED THAT 5 BD LUER-LOK¿ TIP SYRINGES HAD DAMAGED/DEFORMED PLUNGER RODS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS REPORT IS ABOUT FADED PRINTING. THE PRINTING ON THE SYRINGE WAS FADED." VIA BDJ INVESTIGATION TEAM: "BDJ RECEIVED 122 UNUSED SAMPLS. AFTER OBSERVATION, CATEGORIZED THE FOLLOWING DEFECTS. 1. UNUSED PRINT DEFECTS 87. 2. UNOPENED PRINT DEFECTS (LOT#1312426) 3. 3. STAINS 12. 4. PLUNGER DEFORMATION 5. 5. SCRATCHES OR OTHER DAMAGE 9. 6. EMBEDDED FOREIGN MATTER".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17737919 ↗MalfunctionSep 13, 2023Illegible Information; Illegible Information
IT WAS REPORTED THAT 3 BD LUER-LOK¿ TIP SYRINGES HAD LIGHT/FADED SCALE MARKINGS ON THEM. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS REPORT IS ABOUT FADED PRINTING. THE PRINTING ON THE SYRINGE WAS FADED." VIA BDJ INVESTIGATION TEAM: "BDJ RECEIVED 122 UNUSED SAMPLS. AFTER OBSERVATION, CATEGORIZED THE FOLLOWING DEFECTS. 1. UNUSED PRINT DEFECTS 87. 2. UNOPENED PRINT DEFECTS (LOT#1312426) 3. 3. STAINS 12 . 4. PLUNGER DEFORMATION 5. 5. SCRATCHES OR OTHER DAMAGE 9. 6. EMBEDDED FOREIGN MATTER".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17737917 ↗MalfunctionSep 13, 2023Illegible Information; Illegible Information
IT WAS REPORTED THAT 87 OF THE BD LUER-LOK¿ SYRINGE HAD LIGHT SCALE MARKING. REPORT 1 OF 6. THE FOLLOWING WAS TRANSLATED FROM (B)(6) TO ENGLISH: THIS REPORT IS ABOUT FADED PRINTING. THE PRINTING ON THE SYRINGE WAS FADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17737332 ↗MalfunctionSep 8, 2023Crack; Crack
IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP SYRINGE BARREL WAS CRACKED WHEN REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THE CUSTOMER REPORTED THAT THE BARREL WAS CRACKED WHEN OPENED. POTENTIAL LOT NUMBER:23AL100, 23A2400, 23B0700".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17715751 ↗MalfunctionJul 20, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE LEAKAGE OCCURRED. THIS OCCURRED IN 6 BOXES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DETAILS OF THE COMPLAINT ARE OUTLINED BELOW. PRODUCT CODE : 309604 BD 10-CC SYRINGE WITHOUT NEEDLE; LOT # : 2346550; ISSUE : ASPER THE END-USER, WE HAVE A LIQUID LEAKAGE PROBLEM WITH THE 10ML SYRINGES; QUANTITY: 6 BX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17367323 ↗MalfunctionMar 13, 2023Break; Break
IT WAS REPORTED THAT 6 BD LUER-LOK¿ TIP SYRINGES HAD BROKEN/DAMAGED LUER TIPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "DAMAGED COMPONENTS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16529651 ↗
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, ClassifiedSYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
- Z-2753-2017 · Sep 16, 2016 · TerminatedBD 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 · TerminatedBD 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 · TerminatedBD 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 · TerminatedBD 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 · TerminatedBD 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 · TerminatedBD 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 · TerminatedHenry 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 · TerminatedHenry 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 · TerminatedBD 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
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.