N/A 305125Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00382903051250), received between Aug 3, 2018 and Nov 13, 2025 — classified as 2 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (12 reports).

3 other recalls cover devices cleared under the same FDA submission (K021475); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD NEEDLE 25X1 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305125. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE A CURRENT INHOUSE INVESTIGATION OPEN FOR VISIBLE PARTICLES IN WHICH WE UTILIZED YOUR PRECISIONGLIDE NEEDLE 25G X 1 (0.5MM X 25MM) STERILE, BD REF (B)(4) FOR RECONSTITUTION OF SAMPLE VIALS AND ARE REQUESTING THE MATERIAL COMPOSITION OF THE NEEDLE AND PACKAGING MATERIAL. AS WELL AS FOR 1 ML LUER-LOK SYRINGE BD (B)(4), MATERIAL AND PACKAGING COMPOSITION. PRODUCT/MODEL NUMBER: 305125, 309628.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542214 ↗
• MalfunctionJan 8, 2025Complete Blockage; Complete Blockage

  ADDITIONAL INFORMATION RECEIVED. NO ADVERSE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103371 ↗
• MalfunctionDec 29, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION RECEIVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032813 ↗
• MalfunctionDec 29, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032789 ↗
• MalfunctionDec 23, 2024Complete Blockage; Complete Blockage

  MATERIAL#: 305125 BATCH#: 4060114. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WE HAVE HAD 3 IM NEEDLES IN THE LAST TWO DAYS THAT WERE DEFECTIVE. IT SEEMS LIKE THE NEEDLES WERE OCCLUDED. I DON¿T KNOW WHAT THE LOT NUMBER WAS FOR YESTERDAY, AS I WAS JUST INFORMED OF THIS. HOWEVER, THE NEEDLE TODAY WAS FROM LOT NUMBER: 4060014. THESE ARE THE PRECISIONGLIDE NEEDLES 25G X 1¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20999842 ↗
• MalfunctionDec 21, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20996918 ↗
• MalfunctionDec 13, 2024Complete Blockage; Complete Blockage

  ADDITIONAL INFORMATION RECEIVED. HARM TO PATIENT HCP: WAS THERE ANY HARM TO THE PATIENT OR HEALTHCARE PROFESSIONAL (HCP)? PATIENTS HAD TO BE POKED TWICE TO ADMINISTER THE IMMUNIZATION. DELAY IN TREATMENT: DID THE EVENT CAUSE ANY DELAY IN TREATMENT? TREATMENT WAS DELAYED BY A FEW MINUTES IN THE PATIENTS WHO WERE POKED BY THE DEFECTIVE NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931784 ↗
• MalfunctionDec 11, 2024Leak/Splash; Leak/Splash

  MATERIALS: 305125 BATCH#: UNKNOWN. VERBATIM: PLEASE FIND ATTACHED THE NEEDLE EXTENDER VIDEO OF THE LEAK THAT I EITHER MENTIONED TO YOU OR ROB A MONTH OR 2 AGO. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20902235 ↗
• MalfunctionNov 1, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL: 305125. BATCH#: 4060114. IT WAS REPORTED BY THE CUSTOMER THAT WHILE PREPARING A VACCINE, I NOTICED SOME BLACK SORT OF FILAMENT THROUGH THE CAP ON ONE OF YOUR NEEDLES (I HAD NOT YET OPENED IT), WHEN I REMOVED THE CAP IT WAS CLEAR THERE WAS SOME SORT OF IMPURITY ON THE NEEDLE. IF YOU NOTICE ON THE PHOTO OF THE OPENED NEEDLE, THERE IS A LOT OF BLACK FILAMENT AT THE BASE OF THE NEEDLE ON THE WHITE PART. I DID NOT USE IT FOR THE INJECTION AND ISOLATED IT UNTIL I COULD CONTACT YOUR COMPANY. SINCE THEN I HAVE FOUND 2 MORE NEEDLES WITH THE SAME SORT OF IMPURITY ON IT (MUCH LESS, JUST ONE SMALL FILAMENT IT LOOKS LIKE), BUT I HAVE TAKEN TO INSPECTING EACH NEEDLE PRIOR TO INJECTION PREPARATION. I AM NOT SURE IF IT IS THE METAL THAT HAS SPLINTERED OFF OR NOT, BUT IT IS THERE PRIOR TO REMOVING THE CAP FROM THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I HAVE NOTICED AN IMPURITY OR MANUFACTURING DEFECT ON SOME OF YOUR BD PRECISIONGLIDE NEEDLES (SPECIFICALLY REF:(B)(4), LOT: 4060114, EXP: 20209-04-30, 2 SEPARATE BOXES) WHILE PREPARING INJECTIONS. ATTACHED ARE SOME PHOTOS OF THE AFFECTED PRODUCT. WHILE PREPARING A VACCINE, I NOTICED SOME BLACK SORT OF FILAM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586984 ↗
• MalfunctionOct 31, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL: 305125; BATCH#: 4060114. IT WAS REPORTED BY THE CUSTOMER THAT WHILE PREPARING A VACCINE, I NOTICED SOME BLACK SORT OF FILAMENT THROUGH THE CAP ON ONE OF YOUR NEEDLES (I HAD NOT YET OPENED IT), WHEN I REMOVED THE CAP IT WAS CLEAR THERE WAS SOME SORT OF IMPURITY ON THE NEEDLE. IF YOU NOTICE ON THE PHOTO OF THE OPENED NEEDLE, THERE IS A LOT OF BLACK FILAMENTS AT THE BASE OF THE NEEDLE ON THE WHITE PART. I DID NOT USE IT FOR THE INJECTION AND ISOLATED IT UNTIL I COULD CONTACT YOUR COMPANY. SINCE THEN, I HAVE FOUND 2 MORE NEEDLES WITH THE SAME SORT OF IMPURITY ON IT (MUCH LESS, JUST ONE SMALL FILAMENT IT LOOKS LIKE), BUT I HAVE TAKEN TO INSPECTING EACH NEEDLE PRIOR TO INJECTION PREPARATION. I AM NOT SURE IF IT IS THE METAL THAT HAS SPLINTERED OFF OR NOT, BUT IT IS THERE PRIOR TO REMOVING THE CAP FROM THE NEEDLE. NO ADVERSE EVENT OR SERIOUS INJURY REPORTED AS THE NEEDLES WERE UNUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577097 ↗
• MalfunctionFeb 21, 2024Complete Blockage; Device Contamination with Chemical or Other Material; Complete Blockage; Device Contamination with Chemical or Other Material

  MATERIALS#: (B)(4) BATCH#: 2244893 IT WAS REPORTED BY THE CUSTOMER THAT THE CANNULA IS RESTRICTED BY A FOREIGN MATERIAL NEAR NEEDLE OPENING WITHIN THE NEEDLE HUB AND THE VOIDS WHICH ARE NOT PRESENT IN FIGURE BELOW ON LEFT (CLOGGED NEEDLE) DUE TO DRIED DRUG PRODUCT RESIDUE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLE SKU#: BD PRECISION GLIDE 25GX1¿ ART. NO. (B)(4) LOT# 2244893 DESCRIPTION: ¿ OOT NEEDLE (FIGURE BELOW NEEDLE ON LEFT; SHOWN BY THE ARROW) DEMONSTRATES THE CANNULA IS RESTRICTED BY A FOREIGN MATERIAL NEAR NEEDLE OPENING WITHIN THE NEEDLE HUB. THIS IS ALIGNED WITH TESTING RESULTS OF NEEDLE CLOGGING/ BLOCKAGE. ¿ FIGURE BELOW ON RIGHT CIRCLED REGION SHOWS VOIDS WHICH ARE NOT PRESENT IN FIGURE BELOW ON LEFT (CLOGGED NEEDLE) DUE TO DRIED DRUG PRODUCT RESIDUE. THE DIFFERENCE IN CONTRAST (I.E. DENSITIES) BETWEEN THE FOREIGN MATERIAL CAUSING BLOCKAGE OF NEEDLE (ON LEFT) AND THE DRIED DRUG PRODUCT RESIDUE RULE OUT THAT THE FOREIGN MATERIAL IS DRUG PRODUCT RELATED. ADDITIONAL INFORMATION: 1. ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF MM-DD-YYYY? IF UNKNOWN, CAN STATE UNKNOWN. (B)(6) 2024. 2. HOW WAS THE PATIENT OUTCOME? ARE THERE AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753244 ↗
• MalfunctionNov 13, 2023Product Quality Problem; Product Quality Problem

  MAT# 305125, BATCH# 2117120. IT WAS REPORTED BY THE CUSTOMER THAT BD SKU# 305125 IS SUPPOSED TO BE A 25G X 1" HYPODERMIC NEEDLE. HOWEVER, THE CUSTOMER DISCOVERED MULTIPLE INSTANCES OF ROUGHLY 1/2" NEEDLES MIXED IN AMONGST 2 BOXES OF 100. THEY SENT PICTURES AND HAVE RETAINED SAMPLES TO SEND BACK FOR INSPECTION. PLEASE MAKE ARRANGEMENTS TO SEND A PREPAID RETURN KIT TO THE ADDRESS BELOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118445 ↗
• MalfunctionNov 7, 2023Obstruction of Flow; Obstruction of Flow

  NO ADDITIONAL INFORMATION RECEIVED MATERIAL#: 305125 BATCH: 3083975 IT WAS REPORTED BY CUSTOMER THAT THEY ARE ABLE TO DRAW IT OUT OF THE VIAL. HOWEVER, THEY ARE UNABLE TO PUSH THE VACCINE INTO THE MUSCLE. THEY ATTEMPTED AGAIN A SECOND TIME, AND THE SAME THING HAPPENED. INCIDENT DATE: 24OCT2023 VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. (B)(6). REF 305125 NEEDLE 25X1 RB LOT 3083975 THEY ARE ABLE TO DRAW IT OUT OF THE VIAL. HOWEVER, THEY ARE UNABLE TO PUSH THE VACCINE INTO THE MUSCLE. THEY ATTEMPTED AGAIN A SECOND TIME, AND THE SAME THING HAPPENED. INCIDENT DATE: 24OCT2023 THEY STILL HAVE THE NEEDLES TO SEND IN FOR INVESTIGATION, IF NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 18082994 ↗
• MalfunctionOct 3, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED BD® NEEDLE 1 IN. SINGLE USE, STERILE, HAD MIXED PRODUCT IN THE PACKAGE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE ISSUE THAT ONE OF THEIR SITES REPORTED THAT THERE ARE 14 0.5 INCH NEEDLES THAT WERE PACKED WITH THE 1 INCH NEEDLES WHICH WERE SEPARATED FROM THE 1 INCH NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17866122 ↗
• MalfunctionSep 28, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED WHILE USING BD® NEEDLE 1 IN. SINGLE USE, STERILE, 25 G THERE WAS A MIX OF PRODUCT IN THE BOX. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A COUPLE OF NEEDLES ARE 5/8 ARE MIXED IN WITH 1 IN. 2 ARE LABELED AS THE 1 IN AND 2 ARE LABELED AS THE 5/8 IN THE 1 IN BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840368 ↗
• MalfunctionJun 28, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 2 BOXES HAD OTHER SIZED NEEDLES WITH THE BD SAFETYGLIDE¿ NEEDLE ONLY 25 G X 1 IN. THE FOLLOWING WAS RECIEVED BY THE INITIAL REPORTER. VERBATIM: CUSTOMER STATED THAT LABEL SAYS 25 GAUGE X1 BUT SOME OF THE NEEDLES IN THE PACKAGE ARE DIFFERENT SIZES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221715 ↗
• MalfunctionMay 17, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE WAS BLOCKED DURING THE VACCINE INJECTION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWO DIFFERENT NURSES USED SYRINGES FROM THIS BOX. BOTH REPORTED THAT WHEN THEY WENT TO INJECT THE VACCINE INTO THE PATIENT, THE VACCINE WOULD NOT GO THROUGH THE NEEDLE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948103 ↗
• MalfunctionMay 17, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE WAS BLOCKED DURING THE VACCINE INJECTION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWO DIFFERENT NURSES USED SYRINGES FROM THIS BOX. BOTH REPORTED THAT WHEN THEY WENT TO INJECT THE VACCINE INTO THE PATIENT, THE VACCINE WOULD NOT GO THROUGH THE NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948102 ↗
• MalfunctionApr 28, 2023Material Discolored; Material Discolored

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE CANNULA DISCOLORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER CALLED TO REPORT THAT AFTER INJECTION HE NOTICED TIP OF NEEDLE WAS DISCOLORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828789 ↗
• MalfunctionJan 26, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT EXCESSIVE EPOXY WAS FOUND ON THE BD PRECISIONGLIDE¿ NEEDLE AND HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM WRITING TO INFORM YOU OF A DEFECTIVE NEEDLE I HAD RECEIVED FROM MY PHARMACY... THE ANOMALY IS THE WHITE MARKING ON THE SIDE OF THE BLUE NEEDLE BASE. ALL THE OTHER ONES I HAVE USED ARE SOLIDLY BLUE AROUND THAT AREA."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251397 ↗
• MalfunctionOct 29, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE 25 G BD¿ NEEDLE 1 IN. SINGLE USE, STERILE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS INSPECTED UNDER OPTICAL MICROSCOPY AND WE FOUND WHAT APPEARED TO BE ¿BLOCKAGE¿ NEAR THE TIP OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15695704 ↗
• MalfunctionMar 24, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 3 BD HYPO-POSIFLUSH-ANESTHESIA SYRINGE/NEEDLES LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE DISTRIBUTOR REPORTED A CONSUMER HAS HAD A FEW COMPLAINTS OF THEIR BD NEEDLES LEAKING. DATE OF EVENT : UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13888586 ↗
• MalfunctionJan 14, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE 25 G BD¿ NEEDLE 1 IN. SINGLE USE, STERILE HAD THE NEEDLE PENETRATE THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:  IT WAS REPORTED BY THE CONSUMER THE NEEDLE THROUGH THE SHIELD RESULTING IN A NEEDLE STICK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 13259017 ↗
• MalfunctionJul 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN "EXTRA PIECE OF NEEDLE" WAS FOUND ATTACHED TO THE BD PRECISIONGLIDE¿ NEEDLE IN LOT 0022982 WHEN ATTEMPTING TO ADMINISTER A FLU VACCINE. ADDITIONALLY, ANOTHER NEEDLE FROM LOT 0051133 HAD A RING OF EPOXY NEAR THE NEEDLE TIP, AND THE VACCINE COULD NOT BE ADMINISTERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WRITER WAS PREPARING A FLU VACCINE INJECTION AT THE FLU CLINIC. WHEN I WENT TO CHANGE TO NEEDLE ON THE SYRINGE I NOTED AN EXTRA PIECE OF NEEDLE ATTACHED TO THE BLUE HUB. NEEDLE SIZE 25G 1" REF #305125, LOT # 0022982A- NEEDLE WAS PLACED CAREFULLY BACK INTO CAP WITH EXTRA PIECE AND WAS SECURED TO GIVEN TO, PUBLIC HEALTH NURSE. WRITER WAS ADMINISTERING FLU VACCINE TO CLIENT. AFTER PUNCTURING THE SKIN TO INSERT THE NEEDLE IN THE LT DELTOID WRITER NOTICED THE NEEDLE WAS NOT ADVANCING, UPON ASSESSING THE NEEDLE WRITER NOTICED A WHITE PLASTIC RING LOCATED NEAR THE TIP OF THE NEEDLE. NO VACCINE WAS ADMINISTERED , NEEDLE REMOVED, BAND AID APPLIED OVER SITE. WRITER THEN SUCCESSFULLY IMMUNIZED CLIENT IN THE RT DELTOID WITH THE FLU VACCINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240373 ↗
• InjuryJul 28, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED NEEDLE 25X1 RB BROKE OFF INTO THE PATIENT'S BODY DURING INJECTION. THE PATIENT WENT TO THE ER, BUT THEY WERE UNABLE TO REMOVE THE NEEDLE. A FUTURE SURGERY WAS SCHEDULED TO REMOVE THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HE SAID HE WAS RECEIVING AN INJECTION, AND THE NEEDLE SNAPPED OFF THE HUB, AND STAYED IN HIS BODY." "CUSTOMER EXPLAINED THAT THE PODIATRIST HE SEES WAS "DRY NEEDLING" WITH THE HUB AGAINST THE SKIN WHEN THE NEEDLE BROKE - CUSTOMER WENT TO THE ER TO HAVE NEEDLE REMOVED - ER DID NOT REMOVE NEEDLE - CUSTOMER HAS ANOTHER APPT FOR SURGERY TO REMOVE NEEDLE WITH ANOTHER SURGEON".

  Patient problems: Foreign Body In Patient

  MAUDE report 12236644 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021475. One submission often covers many models, so check the product and lot details in each record.

• Z-0588-2021 · Nov 18, 2020 · Terminated
  BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the bo
• Z-0207-2018 · May 31, 2017 · Terminated
  BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain bl
• Z-1009-2012 · Oct 8, 2011 · Terminated
  BD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications