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BD Luer-Lok 309605Recalls & reported problems

Becton, Dickinson And Company · SYRINGE 10ML LL TIP BULK CONVENIENCE PAK · Class 2

All models of BD Luer-Lok (48)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This BD Luer-Lok syringe has 233 adverse event reports, with no injuries and no deaths. The reports mostly describe foreign particles or contamination found in syringes, leaks, and cracks. No recalls name this device. Reports fell from 47 in the previous 12 months to 24 in the last 12 months.

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
228
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 228 adverse event reports that list this exact device (DI 30382903096054), received between Oct 20, 2017 and Sep 21, 2026 — classified as 228 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (65 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.

Reports received per month

Nov 2023: 3 reportsDec 2023: 4 reportsJan 2024: 4 reportsFeb 2024: 2 reportsMar 2024: 0 reportsApr 2024: 5 reportsMay 2024: 2 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 3 reportsOct 2024: 3 reportsNov 2024: 0 reportsDec 2024: 7 reportsJan 2025: 5 reportsFeb 2025: 3 reportsMar 2025: 3 reportsApr 2025: 12 reportsMay 2025: 6 reportsJun 2025: 0 reportsJul 2025: 3 reportsAug 2025: 1 reportsSep 2025: 1 reportsOct 2025: 6 reportsNov 2025: 2 reportsDec 2025: 3 reportsJan 2026: 0 reportsFeb 2026: 4 reportsMar 2026: 1 reportsApr 2026: 5 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 1 reportsAug 2026: 1 reportsSep 2026: 1 reportsOct 2026: 0 reports20242025202612
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Contamination with Chemical or Other Material65
  • Leak/Splash39
  • Contamination /Decontamination Problem30
  • Crack21
  • Contamination15
  • Device Markings/Labelling Problem14
  • Defective Component12
  • Volume Accuracy Problem10

Patient problems

  • No Clinical Signs, Symptoms or Conditions130
  • No Known Impact Or Consequence To Patient79
  • No Consequences Or Impact To Patient9
  • No Patient Involvement9
  • Insufficient Information1
  • No Information1

Recent adverse event reports

The 25 most recent of 228 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 21, 2026Contamination /Decontamination Problem

    It was reported that BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK contained foreign matterComplaint via Phone. Case description: Customer reported finding large white particles inside the syringe. She stated that the particles were attached to the plunger and that she had never seen anything like this before. Product: BD Luer-Lok Syringe.Ref#: 309605.Lot#: 6133350.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50842474 ↗
  • MalfunctionAug 27, 2026Contamination

    It was reported that BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK contained foreign matter.Verbatim: Complaint via Email. Email attached.DMR # (b)(4) PO #: (b)(4)Defect Material Description: Syringe Tray, 10mL BD 20PK (Ref. 309605)Lot number: 6078987Item Code: 309605Defective quantity: 10Defect description: Marking on the barrel of the 10 mL syringe, that seems like something chemically interacted with the plastic. 2 samples available to be returned.Observed date: (b)(6) 2026Observed during which process stage: ILPIR/ DMI number if launched: Sample availability for supplier to investigate: YESIs defective evidence (i.e. Pictures; test results etc.) available? YESIs patient impacted? NOIf defect has been reported to third party? NOIf the defect report from QuVa customer? NOIs there a Trend observed? NO Supplier Action Investigation Required

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50479185 ↗
  • MalfunctionJul 28, 2026Contamination

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50059455 ↗
  • MalfunctionJun 17, 2026Contamination

    IT WAS REPORTED THAT BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK CONTAINED FOREIGN MATTER. MATERIAL#: 309605. BATCH#: 5310147. IT WAS REPORTED BY THE CUSTOMER THAT ONE SYRINGE WAS FOUND TO CONTAIN A FOREIGN PARTICULATE. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ON 05/27/2026, DURING VISUAL INSPECTION OF LOT 20260520-54152A X HCI 1000 MCG IN 10 ML SYRINGE, ONE SYRINGE WAS FOUND TO CONTAIN A FOREIGN PARTICULATE. THIS UNIT IS AVAILABLE FOR RETURN. PRODUCT: STERILE SYRINGE TRAY 10ML. LOT NUMBER: 5310147. PART NUMBER: 309605. NUMBER OF DEFECTIVE UNITS: 1. DEFECT TYPE: FOREIGN PARTICULATE. PRODUCT COMPLAINT : (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25540107 ↗
  • MalfunctionApr 21, 2026Contamination /Decontamination Problem

    IT WAS REPORTED THAT BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK CONTAINED FOREIGN MATTER. COMPLAINT VIA EMAIL. DURING VISUAL INSPECTION OF LOT 20260330-5298A2, PHENYLEPHRINE HCI 1000 MCG IN 10 ML OF NS SYRINGE, ONE SYRINGE WAS FOUND TO HAVE AN INK SPOT ON THE PLUNGER LID, ONE WAS FOUND TO HAVE A DEFECTIVE PLUNGER SEAL AND ONE HAD DEFECTIVE SYRINGE MARKINGS WITH THE NUMBERS FADED OFF COMPLETELY. THESE UNITS ARE AVAILABLE FOR RETURN. DETAILS FOR YOUR INVESTIGATION: PRODUCT: STERILE SYRINGE TRAY 10ML LOT NUMBER: 5310147 PART NUMBER: 309605 NUMBER OF DEFECTIVE UNITS: 3 DEFECT TYPE: INK SPOT, SYRINGE DEFECT & DEFECTIVE SYRINGE MARKINGS PRODUCT COMPLAINT: (B)(4). CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 30-MAR-2026 DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. N/A ¿ NO PATIENT USAGE AT THIS POINT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24943397 ↗
  • MalfunctionApr 17, 2026Contamination /Decontamination Problem

    IT WAS REPORTED THAT BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK SLIPPERY SYRINGE. VERBATIM: COMPLAINT VIA PHONE. CASE DESCRIPTION: THEY ORDERED THE PRODUCT AND THEY NOTICED IT'S MADE OF A DIFFERENT MATERIAL. THEY STICK LABELS TO IT USUALLY BUT THE LABELS ARE NOT STICKING WELL ON THIS ONE BECAUSE THE MATERIAL IS SLIPPERY. IN CASE OF A CONFIRMED PRODUCT COMPLAINT, THEY WANT A REPLACEMENT. CUSTOMER NAME: X PHONE NUMBER: X EMAIL: X FACILITY NAME: X FACILITY ADDRESS: X PRODUCT: 10 ML BD LUER-LOK SYRINGE PHARMACY CONVENIENCE PAK, REF#: 309605, LOT#: 5353731 - THEY HAVE (B)(4) CASES, 5328426 - THEY HAVE (B)(4) FULL CASES. COULD YOU PLEASE SHARE THE TOTAL NUMBER OF OCCURRENCES AND THE QUANTITY AFFECTED FOR THE REPORTED ISSUE, AFTER WE PROCEEDED WITH THE REPLACEMENT REQUEST? I CANNOT PROVIDE NUMBERS BASED ON THIS. WE HAVE HAD SEVERAL PHARMACY TECHNICIANS COMPLAIN ALL SYRINGES (EVEN IN DIFFERENT TRAY) WITHIN THE LOT HAVE THE SAME NON-STICKING/ADHERING PROBLEM. NUMBERS WERE NOT REPORTED TO ME, UNFORTUNATELY. CLARIFY IF SLIPPERY SUBSTANCE WAS NOTED NEAR THE LEUR OR INSIDE THE SYRINGE? THE SLIPPERY FEEL IS ON THE OUTSIDE OF THE SYRINGE. IT IS THE WHOLE ENTIRE BARREL FROM THE LUER LOCK TIP TO T

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24911731 ↗
  • MalfunctionApr 8, 2026Contamination

    IT WAS REPORTED THAT BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK CONTAINED FOREIGN MATTER. COMPLAINT VIA EMAIL. DURING VISUAL INSPECTION OF LOT: 20260312 651B82 PHENYLEPHRINE HCI 1000 MCG IN 10 ML OF NS SYRINGE, 1 SYRINGE WAS DISCOVERED TO HAVE A FOREIGN PARTICULATE. UNIT IS AVAILABLE FOR RETURN UPON REQUEST. DETAILS FOR YOUR INVESTIGATION: PRODUCT: 50ML SYRINGE, LOT NUMBER: 5282734, PART NUMBER: 309653, NUMBER OF DEFECTIVE: UNITS 1, DEFECT TYPE: DURING VISUAL INSPECTION 1 SYRINGE WAS FOUND TO CONTAIN A FOREIGN PARTICULATE, PRODUCT COMPLAINT: (B)(4), QUANTITY: (B)(4). ADDITIONAL INFORMATION RECEIVED ON 20MAR2026. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DDMMMYYYY? THE PRODUCT WAS CREATED 3/12/2026. THE PARTICULATE WAS DISCOVERED ON (B)(6) 2026. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. N/A NO PATIENT USAGE AT THIS POINT. THE DESCRIPTION STATES, ¿DURING VISUAL INSPECTION OF LOT: 20260312 651B82 PHENYLEPHRINE HCL 1000 MCG IN 10 ML OF NS SYRINGE.¿ HOWEVER, THE PROVIDED MATERIAL NUMBER: 309653. CORRESPONDS TO A 50 ML PRODUCT. COULD YOU PLEASE RECHECK AND CONFIRM WHICH MATERIAL IS IMPACTED? THE PART NUMBER

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24818518 ↗
  • MalfunctionApr 8, 2026Contamination

    IT WAS REPORTED THAT BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK CONTAINED FOREIGN MATTER. COMPLAINT VIA EMAIL. DURING VISUAL INSPECTION OF LOT 20260312 651B82 PHENYLEPHRINE HCI 1000 MCG IN 10 ML OF NS SYRINGE, 1 SYRINGE WAS DISCOVERED TO HAVE A FOREIGN PARTICULATE. UNIT IS AVAILABLE FOR RETURN UPON REQUEST. DETAILS FOR YOUR INVESTIGATION PRODUCT 50ML SYRINGE LOT NUMBER 5282734 PART NUMBER 309653 NUMBER OF DEFECTIVE UNITS 1 DEFECT TYPE DURING VISUAL INSPECTION 1 SYRINGE WAS FOUND TO CONTAIN A FOREIGN PARTICULATE PRODUCT COMPLAINT (B)(4) QUANTITY (B)(4). ADDITIONAL INFORMATION RECEIVED ON 20MAR2026 CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DDMMMYYYY? THE PRODUCT WAS CREATED 3/12/2026. THE PARTICULATE WAS DISCOVERED (B)(6) 2026. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. N/A NO PATIENT USAGE AT THIS POINT. THE DESCRIPTION STATES, ¿DURING VISUAL INSPECTION OF LOT 20260312 651B82 PHENYLEPHRINE HCL 1000 MCG IN 10 ML OF NS SYRINGE.¿ HOWEVER, THE PROVIDED MATERIAL NUMBER 309653 CORRESPONDS TO A 50 ML PRODUCT. COULD YOU PLEASE RECHECK AND CONFIRM WHICH MATERIAL IS IMPACTED? THE PART NUMBER IMPACTED IS 309605. TH

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24818516 ↗
  • MalfunctionApr 2, 2026Contamination

    IT WAS REPORTED THAT BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK CONTAINED FOREIGN MATTER. COMPLAINT VIA PHONE. PLUNGER OF SYRINGE IS DIRTY; IT APPEARS IN SOME PLACES THE PLASTIC IS DISCOLORED AND IN OTHERS IT DOES LOOK LIKE DIRT. 27-MAR-2026: NO PATIENT CONCERNS FOR THIS INSTANCE. DELIVERY ADDRESS (B)(6). DATE OCCURRED ON (B)(6) 2026.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24767207 ↗
  • MalfunctionMar 5, 2026Contamination

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24523781 ↗
  • MalfunctionFeb 16, 2026Packaging Problem

    BLACK STRIP ON BACK OF PACKAGING, WHEN SEPARATED NOTED THAT NOT SEALED WHERE BLACK STRIP IS PRESENT REPRESENTING CONCERN FOR STERILITY. NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24345559 ↗
  • MalfunctionFeb 13, 2026Contamination /Decontamination Problem

    IT WAS REPORTED THAT BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK CONTAINED FOREIGN MATTER. RCC RECEIVED A COMPLAINT VIA EMAIL. PLEASE SEE THE ATTACHED IMAGE(S) AND DETAILS OF REPORTED DEFECTIVE MATERIAL: DMR # (B)(4) PO #: (B)(4) DEFECT MATERIAL DESCRIPTION: SYRINGE TRAY, 10ML BD 20PK (REF. 309605) LOT NUMBER: 5274495 AND 5275045 ITEM CODE: 309605 DEFECTIVE QUANTITY: 1 EA DEFECT DESCRIPTION: BROWN PARTICULATES BEING IMBEDDED IN THE PLASTIC OF THE SYRINGE BARREL WALL. OBSERVED DATE: (B)(6) 2026 OBSERVED DURING WHICH PROCESS STAGE: MARKET IR/ DMI NUMBER IF LAUNCHED: SAMPLE AVAILABILITY FOR SUPPLIER TO INVESTIGATE: YES IS DEFECTIVE EVIDENCE (I.E. PICTURES; TEST RESULTS ETC.) AVAILABLE? YES IS PATIENT IMPACTED? NO IF DEFECT HAS BEEN REPORTED TO THIRD PARTY? NO IF THE DEFECT REPORT FROM QUVA CUSTOMER? NO IS THERE A TREND OBSERVED? NO

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24330042 ↗
  • MalfunctionFeb 13, 2026Contamination /Decontamination Problem

    IT WAS REPORTED THAT BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK CONTAINED FOREIGN MATTER. RCC RECEIVED A COMPLAINT VIA EMAIL. PLEASE SEE THE ATTACHED IMAGE(S) AND DETAILS OF REPORTED DEFECTIVE MATERIAL: DMR # (B)(4), PO #: (B)(4). DEFECT MATERIAL DESCRIPTION: SYRINGE TRAY, 10ML BD 20PK (REF. 309605) LOT NUMBER: 5274495 AND 5275045, ITEM CODE: 309605, DEFECTIVE QUANTITY: 1 EA. DEFECT DESCRIPTION: BROWN PARTICULATES BEING IMBEDDED IN THE PLASTIC OF THE SYRINGE BARREL WALL. OBSERVED DATE: (B)(6) 2026. OBSERVED DURING WHICH PROCESS STAGE: MARKET IR/ DMI NUMBER IF LAUNCHED: SAMPLE AVAILABILITY FOR SUPPLIER TO INVESTIGATE: YES, IS DEFECTIVE EVIDENCE (I.E. PICTURES, TEST RESULTS ETC.) AVAILABLE? YES, IS PATIENT IMPACTED? NO, IF DEFECT HAS BEEN REPORTED TO THIRD PARTY? NO, IF THE DEFECT REPORT FROM QUVA CUSTOMER? NO, IS THERE A TREND OBSERVED? NO.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24330040 ↗
  • MalfunctionFeb 11, 2026Contamination /Decontamination Problem

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24314334 ↗
  • MalfunctionDec 30, 2025Nonstandard Device; Manufacturing, Packaging or Shipping Problem; Nonstandard Device; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK CONTAINED A PLUNGER ROD THAT WAS BROKEN / DAMAGED. DEFECT ¿ DAMAGE TO THE PLUNGER ROD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23927654 ↗
  • MalfunctionDec 15, 2025Contamination; Contamination

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309605, BATCH#: 5211789. RCC RECEIVED A COMPLAINT VIA EMAIL. UPON VISUAL INSPECTION OF SYRINGES, IT WAS DISCOVERED THAT THERE WERE 205 COSMETIC DEFECTS RELATING TO OFF-COLORED MATTER EMBEDDED IN THE GROOVES OF THE SYRINGE. SOLUTION DOES NOT TOUCH THAT AREA, AND IT DOES NOT MOVE. THE MATTER ALSO APPEARS TO BE COLORED PLASTIC LIKE PARTICLES. ITEM: D309605, LOT#: 5211789, EXPIRY: 06/30/2030.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23812386 ↗
  • MalfunctionDec 4, 2025Contamination; Contamination

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23723473 ↗
  • MalfunctionNov 5, 2025Crack; Crack

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #309605 LOT #5241727. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. CUSTOMER STATES THAT THEY HAD SOME OF THE 10ML LUERLOCK SYRINGES CRACK. CUSTOMER HAS PRODUCT TO RETURN IF NEEDED. CUSTOMER DID NOT HAVE THE PRODUCT NUMBER OR THE CERTAIN LOT NUMBER BUT THEY DID HAVE THE LOT NUMBER THAT THEY HAVE ONSITE (NOT SURE IF IT'S THE SAME LOT THAT CRACKED). LOT NUMBER 5241727,309605. ADDITIONAL INFORMATION PROVIDED: TO FOLLOW UP, WE HAD MORE CRACKING. I WAS ALSO INFORMED BY MY TECH THAT THEY HAVE BEEN FINDING THEM CRACKED BEFORE THEY EVEN USE THEM, IT IS USUALLY 1-2 FROM EACH BOX OF THE 20 SYRINGES. NEW LOT NUMBER: 5260078. ADDITIONAL INFORMATION RECEIVED ON 10/29/2025: MAJORITY WAS DURING USE HOWEVER ONE OF MY TECHS HAS MENTIONED THAT SHE SEEN SOME BROKEN PRIOR TO USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23475682 ↗
  • MalfunctionNov 3, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23459691 ↗
  • MalfunctionOct 31, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23444239 ↗
  • MalfunctionOct 30, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23432708 ↗
  • MalfunctionOct 30, 2025Crack; Crack

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 309605, BATCH#: UNKNOWN (PROVIDED LOT: 5121433, 5211788). RCC RECEIVED A COMPLAINT VIA EMAIL. DURING COMPOUNDING OF LOT#: 20251008-96D150 THE FOLLOWING SYRINGE ISSUES WERE NOTICED, 1 CRACKED SYRINGE - AVAILABLE FOR RETURN. 1 SYRINGE WITH NO MARKINGS ¿ NOT AVAILABLE FOR RETURN. 1 SYRINGE WITH FADED MARKINGS¿ NOT AVAILABLE FOR RETURN. 1 SYRINGE WILL ALMOST NO MARKINGS¿ NOT AVAILABLE FOR RETURN. 2 WITH FOREIGN PARTICULATE ON THE RUBBER STOPPER (DOES NOT APPEAR TO MOVE) ¿ NOT AVAILABLE FOR RETURN. TWO DIFFERENT LOT# WERE USED IN COMPOUNDING SO I¿M UNSURE THE LOT# IN WHICH THE COMPLAINTS ARE FROM. DATE OF THE COMPLAINT IS ON (B)(6) 2025. NO PATIENTS ARE INVOLVED. ON (B)(6) 2025: PCC-25-135, STERILE SYRINGE TRAY 10ML, 309605 EXPIRY 4/30/2309 AND 6-30-2030 5121433, 5211788, SYRINGE MARKINGS, MISSING MARKINGS, FADED MARKINGS, 3. ON (B)(6) 2025: PCC-25-135, STERILE SYRINGE TRAY 10ML, 309605, EXPIRY 4/30/2309 AND 6-30-2030 5121433, 5211788, FOREIGN PARTICULATE, SITTING ON THE STOPPER 2. ON (B)(6) 2025: PCC-25-135, STERILE SYRINGE TRAY

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23432705 ↗
  • MalfunctionOct 21, 2025Break; Defective Component; Break; Defective Component

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23354277 ↗
  • MalfunctionOct 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23354276 ↗
  • MalfunctionOct 21, 2025Leak/Splash; Leak/Splash

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23354275 ↗

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-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-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-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-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-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-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-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

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Sources and updates

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