BD Luer-Lok, BD SafetyGlide 305924Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00382903059249), received between Dec 11, 2017 and Jul 28, 2025 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jul 28, 2020Class IITerminated

   Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, resulting in missing and/or partially printed scale numbers and scale lines.

   Z-2889-2020 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Contamination; Contamination

  IT IS REPORTED, FOREIGN MATTER. EVENT DESCRIPTION: MATERIAL # 305924 LOT # 4073358 WE WOULD LIKE TO REPORT THIS MANUFACTURING DEFECT. THE SYRINGE WAS VISIBILITY DIRTY WHEN REMOVED FROM PACKAGING. PATIENT IMPACTED? : NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22630008 ↗
• MalfunctionAug 29, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE 25 G X 1 IN. WITH 3 ML SYRINGE THE SAFETY MECHANISM FAILED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT: SAFETY MECHAMISM WAS NOT WORKING PROPERLY AND MADE THE NEEDLE BENT OCCURRENCE: 1. CUSTOMER REQUEST REPLACEMENT FOR 6 BOXES OF PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643084 ↗
• MalfunctionMar 2, 2022Break; Break

  IT WAS REPORTED THAT THE PLUNGER ROD WAS BROKEN ON THE BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿SYRINGE PLUNGER DOES NOT HAVE PLUNGER TOP FOR FINGER TO PUSH VACCINE IN WITH PLUNGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654222 ↗
• MalfunctionJun 28, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE SEPARATED FROM THE SYRINGE AND LEAKED THE VACCINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE CAME APART FROM SYRINGE WITH THE DTAP-IPV-HIB -HB SPRAYING VACCINE ON THE BABY. DOSE REPEATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12076974 ↗
• MalfunctionApr 6, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 6 BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLES HAD VISIBLE CRACKS ON THEIR SYRINGES THAT LEAKED VACCINE MEDICINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DILUENT WAS DRAWN UP AND BEING INJECTED INTO PFIZER COVID VACCINE VIAL. WRITER NOTED DROPS OF FLUID APPEARING ON OUTDID OF SYRINGE FROM VERTICAL CRACK VISIBLE/PALPABLE ON SYRINGE. CONSEQUENTLY, SIX (6) DOSES OF VACCINE WAS DISCARDED AS UNSURE OF EXACT AMOUNT OF DILUENT THAT HAD BEEN INJECTED INTO VIAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624918 ↗
• MalfunctionDec 26, 2019Fungus in Device Environment; Device Contamination with Chemical or Other Material; Fungus in Device Environment; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB HAD MOLD LOCATED ON THE NEEDLE HUB. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305924, BATCH NO.: 8064678 & 8119703. IT WAS REPORTED THERE APPEARED TO BE MOLD LOCATED IN THE NEEDLE HUB. VERBATIM: NURSE WENT TO OPEN BD SAFETYGLIDE(3ML 25G X 1) LOT # 8064678. LOCATED IN THE NEEDLE HUB WAS WHICH APPEARS TO BE MOLD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9520348 ↗
• MalfunctionDec 20, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB HAS BEEN FOUND CONTAINING AN UNKNOWN LIQUID BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS A GEL LIKE SUBSTANCE WHICH SEEMS TO BE LUBRICANT IN THE SYRINGE AND ON THE STOPPER. CN CALLED STATING THAT THIS SEEMS TO BE A WIDE SPREAD PROBLEM ON GOING, THAT A LOT OF THE SYRINGES USED AT THEIR FACILITIES HAVE THE SAME VOLUME OF GEL LIKE SUBSTANCE WHICH SEEMS TO BE LUBRICANT IN THE SYRINGE AND ON THE STOPPER. REF NO (B)(4) LOT NOS. 8064678, 8119703.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9505608 ↗
• MalfunctionDec 19, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305924. BATCH NO.: 7347873. PER PHONE CALL ON (B)(6) 2019: MANAGER CALLED TO REPORT THAT NURSES AT HER FACILITY HAVE MULTIPLE BOXES OF 305924 SYRINGES THAT CONTAIN A CLEAR FLUID, WHICH IS POSSIBLY THE LUBRICANT, POOLING UP INSIDE THE SYRINGE AND BUBBLES AROUND THE STOPPER. THEY DO NOT USE THESE. BEEN AN ONGOING ISSUE WITH THESE BOXES.

  Patient problems: No Patient Involvement

  MAUDE report 9498049 ↗
• MalfunctionDec 13, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB HAS BEEN FOUND EXPERIENCING FIVE OCCURRENCES OF CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT FLUID/LUBRICANT/SUBSTANCE IN THE 3 ML BD SYRINGE. PER CUSTOMER EMAIL: THERE APPEARS TO BE FLUID/LUBRICANT/SUBSTANCE IN THE 3 ML BD SYRINGE WHEN THE NURSE OPENED THE PACKAGE TO TAKE THE SYRINGE OUT PRIOR TO WITHDRAWING VACCINE. THIS HAS HAPPENED TO SEVERAL SYRINGES NOTED BY THIS NURSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9467314 ↗
• MalfunctionDec 6, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB PLUNGER DETACHED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305924 BATCH NO. 7093912. IT WAS REPORTED THAT THE PLUNGER DETACHED FROM THE BLACK RUBBER. PER EMAIL FROM CUSTOMER: PLUNGER DETACHED FROM THE BLACK RUBBER AFTER DRAWING UP VACCINE. PLUNGER IS LOOSE AND SLIDES TO END OF SYRINGE. THIS IS THE SECOND ONE IN A WEEK BUT FROM A DIFFERENT BOX. NO OTHERS IDENTIFIED IN THE BOX.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9425918 ↗
• MalfunctionNov 27, 2019Leak/Splash; Leak/Splash

  MATERIAL NO. 305924. BATCH NO. 7093907. IT WAS REPORTED THAT BEFORE USE OF THE BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE THE PLUNGER WAS NOT ATTACHED TO THE RUBBER TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER NOT ATTACHED TO THE RUBBER TIP, NO WAY TO DRAW UP VACCINE. SLIDES RIGHT TO THE END IF HELD UP. ANOTHER PACKAGE IN THE BOX HAD A DEFECTIVE PLUNGER WHERE THE BLACK RUBBER WAS "WAVY" AND FLUID LEAKED PAST THE PLUNGER AND OUT THE END OF THE TUBE. THE NURSE WAS UNABLE TO SAVE THIS PRODUCT BECAUSE THERE WAS VACCINE IN IT AND SO IT WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9386118 ↗
• MalfunctionJul 29, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT 5 BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLES WERE MISSING THEIR SCALE MARKINGS, AND 1 SYRINGE WAS FOUND WITH THE INCORRECT VOLUME ON IT. ALL DEFECTS WERE FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SYRINGE IS MISSING THE MARKINGS. ONE SYRINGE HAD THE INCORRECT VOLUME ON THE SYRINGE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8836414 ↗
• MalfunctionApr 18, 2019Device Markings/Labelling Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305924 BATCH NO:8289599 IT WAS REPORTED THAT FACILITY DISCOVERED SYRINGES WITH EITHER FADED OR NON EXISTENT MARKINGS. PER CUSTOMER EMAIL: I WANTED TO SHARE WITH YOU THAT WE CAME ACROSS A SAFETY ISSUE HERE INVOLVING 3ML 25G NEEDLES/SYRINGES. WE REPORTED THIS AND HAVE NOTIFIED THE PROCUREMENT TEAM. THE MARKINGS ON THE SIDE OF THE SYRINGE ARE EITHER FADED OR NON-EXISTENT, AND SOMETIMES EVEN CAUSE THE 1.5 ML MARK TO READ AS 1 ML. THEY ARE REF # (B)(4) AND LOT # 8289599.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8527482 ↗
• MalfunctionMar 7, 2019Leak/Splash

  IT WAS REPORTED THAT WHEN A VACCINE WAS ADMINISTERED WITH A SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB LIQUID CAME SQUIRTING OUT OF THE PLUNGER SIDE. THE REPORT IS AS FOLLOWS, "VACCINE WAS DRAWN INTO THE SYRINGE FOR IMMUNIZATION AND ADMINISTRATION, CLIENT'S SKIN WAS PUNCTURED AND WHEN VACCINE WAS TO BE ADMINISTERED, LIQUID CAME SQUIRTING OUT OF THE PLUNGER SIDE. CLIENT NEEDED TO HAVE NEW VACCINE ADMINISTERED TO ALTERNATE ARM."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8400137 ↗
• MalfunctionFeb 20, 2019Leak/Splash

  IT WAS REPORTED THAT THE VACCINE LEAKED PAST THE PLUNGER AND OUT THE BOTTOM OF THE BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE'S SYRINGE WILL DRAWING UP THE MEDICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8354096 ↗
• MalfunctionJan 29, 2019Leak/Splash

  IT WAS REPORTED THAT DURING USE OF A BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE LEAKED AROUND THE PLUNGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8287379 ↗
• MalfunctionDec 3, 2018Leak/Splash

  IT WAS REPORTED THAT A BD SYRINGE LL W/NDL SFTYGLD RB WAS LEAKED DURING USE.

  Patient problems: No Information

  MAUDE report 8125066 ↗
• MalfunctionNov 16, 2018Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED THAT A BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE HAD A PLUNGER THAT WAS NOT LEVEL WITH THE SCALE MARKINGS. SPRAY ALSO CAME FROM THE PLUNGER DURING USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8080924 ↗
• MalfunctionNov 12, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE CONTAINED FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8060239 ↗
• MalfunctionNov 9, 2018Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE CONTAINED A FOREIGN OBJECT IN THE SYRINGE. NO SERIOUS INJURY, EXPOSURE, OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8057235 ↗
• MalfunctionAug 15, 2018Product Quality Problem

  IT WAS REPORTED WITH THE USE OF THE BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE THERE WAS AN ISSUE WITH INCORRECT NEEDLE LENGTH. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7786196 ↗
• MalfunctionJun 28, 2018Leak/Splash

  IT WAS REPORTED WITH THE USE OF A BD SAFETYGLIDE¿ SHIELDING HYPODERMIC THE NEEDLE WAS FOUND LEAKING AS "DURING INJECTION OF VACCINE, THE MAJORITY OF THE VACCINE PASSED THE SEAL OF THE PLUNGER AND BACKED TO THE BARREL OF THE SYRINGE. THE CLIENT DID NOT RECEIVE A FULL DOSE AND THEY WERE REQUIRED TO INJECT THE CHILD A SECOND TIME TO ADMINISTER A COMPLETE FULL DOSE. UPON CLOSER INSPECTION OF THE SYRINGE, IT WAS NOTED THAT THE PLUNGER WAS MISSHAPED ON ONE SIDE." THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7648761 ↗
• MalfunctionMar 26, 2018Leak/Splash

  IT WAS REPORTED THAT MEDICATION LEAKED FROM A BD SAFETYGLIDE¿, REGULAR BEVEL NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7370402 ↗
• MalfunctionMar 23, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER (DESCRIBED AS A ¿GREASY STICKY SUBSTANCE¿) WAS FOUND IN A BD SAFETYGLIDE, REGULAR BEVEL NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7366415 ↗
• MalfunctionMar 12, 2018Crack

  IT WAS REPORTED THAT BEFORE USE A BD SAFETYGLIDE¿ SYRINGE WITH NEEDLE MALFUNCTIONED AS ¿THE RUBBER STOPPER APPEARED CRACKED UPON INSPECTION BEFORE USE.¿ THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7330936 ↗