BD Safety-Lok 305901Recalls & reported problems

Summary

The FDA's MAUDE database contains 176 adverse event reports that list this exact device (DI 00382903059010), received between Nov 27, 2017 and Sep 16, 2026 — classified as 14 injuries, 162 malfunctions.

The most frequently reported specific device problem is “Break” (25 reports).

4 other recalls cover devices cleared under the same FDA submission (K951254); 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 176 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792554 ↗
• MalfunctionAug 6, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50164196 ↗
• MalfunctionJul 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25856905 ↗
• MalfunctionJul 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25838645 ↗
• MalfunctionJul 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25817325 ↗
• MalfunctionJul 2, 2026Connection Problem

  IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X5/8 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHILE GIVING THE INJECTION, AFTER PUSHING THE PLUNGER AND REMOVING THE SYRINGE, WE HEARD A CLICK AND THE NEEDLE SEPARATED FROM THE SYRINGE. NEEDLE WAS REMOVED FROM PT LEG AND DISCARDED. PT WAS NOT HARMED, NO MEDICATION SPILLED FROM NEEDLE OR SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25696483 ↗
• MalfunctionJul 2, 2026Break; Material Separation

  IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF HUB. DURING INJECTION OF A 2-MONTH-OLD BABY, NEEDLE SEPARATED FROM HUB AND NEEDLE REMAINED IN PATIENT'S MUSCLE. PATIENT HAD A RETAINED PARTIAL NEEDLE POST INJECTION. SAFETY WAS NOT ABLE TO BE ENGAGED CREATING ANOTHER SAFETY CONCERN. FIRST NAME: (B)(6). LAST NAME: (B)(6). CITY: (B)(6) SERIOUS INJURY PATIENT HAD A RETAINED PARTIAL NEEDLE POST INJECTION. SAFETY WAS NOT ABLE TO BE ENGAGED CREATING ANOTHER SAFETY CONCERN. 12-JUN-2026: HERE IS THE REQUESTED INFORMATION: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. PICTURE AVAILABLE IS MENTIONED AS YES, IF POSSIBLE, COULD YOU PLEASE PROVIDE PICTURE SAMPLES FOR INVESTIGATION? WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? ADDITIONAL OBSERVATION AND EVALUATION BY PEDIATRICIAN IN A CLINIC SETTING AND REASSURANCE TO PARENTS.

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

  MAUDE report 25693112 ↗
• MalfunctionJun 29, 2026Break

  IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X5/8 RB NEEDLE WAS BROKEN. VERBATIM: WE HAD AN ISSUE WITH A NURSE HAVING THE NEEDLE OF THE 25G X 5/8" REF: 305901 BREAKING OFF AND GETTING STUCK IN A VACCINE VIAL. VIAL AND NEEDLE HAVE BEEN DISPOSED OF, BUT WE WERE JUST WONDERING IF THIS IS SOMETHING THAT CAN HAPPEN FROM HUMAN ERROR OR IF IT IS A KNOWN ISSUE WITH SOME OF THE NEEDLES. IS IT OK TO USE THE REMAINING NEEDLES IN THE BOX? NONE OF THE PREVIOUS NEEDLES HAD THIS ISSUE THAT WERE TAKEN FROM THE BOX, JUST THIS SPECIFIC ON. THANKS, ADDITIONAL INFORMATION: DATE OF THE INCIDENT WAS MAY (B)(6) 2026 AND LOT # 4058321.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659270 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF HUB. VERBATIM: NEEDLE DETACHED FROM HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160273 ↗
• MalfunctionMay 8, 2026Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124726 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF HUB. COMPLAINT VIA EMAIL. THE NEEDLES SEEM TO NOT BE SEATED CORRECTLY AND ARE BREAKING OFF WHEN USED TO DRAW UP INJECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956486 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF HUB. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED THE NEEDLES SEEM TO NOT BE SEATED CORRECTLY AND ARE BREAKING OFF WHEN USED TO DRAW UP INJECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956483 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF HUB. COMPLAINT VIA EMAIL. WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER, (B)(6), AND INCLUDE COMPLAINT#: (B)(4) ON ANY FUTURE COMMUNICATIONS. INJURIES OR ADVERSE EVENT: NO. ITEM: 305901. QUANTITY AFFECTED:1 EACH. SERIAL/LOT NUMBER: (B)(6). PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE NEEDLE OUT OF THE PATIENT'S INJECTION SITE AND ENGAGED THE SAFETY, THE NEEDLE CAME DISLODGED FROM THE BASE ON THE NEEDLE. CUSTOMER DISPOSITION REQUEST: CREDIT. CUSTOMER CONTACT INFORMATION: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905933 ↗
• MalfunctionApr 6, 2026Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796290 ↗
• MalfunctionApr 6, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X5/8 RB CONTAINED FOREIGN MATTER. COMPLAINT VIA PHONE. CASE DESCRIPTION: THERE IS A HAIR STICKING OUT OF THE CAP, SHE CAN EVEN SEE THE HAIR FOLLICLE. PRODUCT: BD SAFETYGLIDE¿ NEEDLE 25 G X 5/8 IN. REF#: 305901, LOT#: 5080421. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 19-MAR-2026. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NEAR MISS. NO PATIENT HARM OCCURRED. NURSE WENT TO ATTACH THE NEEDLE TO SYRINGE BUT COULD CLEARLY SEE THE HAIR STICKING OUT OF THE CAP AND DID NOT USE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791164 ↗
• MalfunctionApr 2, 2026Break; Detachment of Device or Device Component

  "NO ADDITIONAL INFORMATION WAS PROVIDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767372 ↗
• MalfunctionMar 25, 2026Break

  IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #305901 BATCH #5080421 VERBATIM: STAFF WAS TRYING TO MIX DILUENT WITH VACCINE AND THE NEEDLE CAME COMPLETELY OUT OF THE SAFETY GLIDE NEEDLE AND WAS STUCK IN THE DILUENT VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24693911 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305901 BATCH # 5295926 VERBATIM: EMAIL ¿ COMPLAINT VIA EMAIL ATTACHED DISTRIBUTION IS PROVIDING NOTIFICATION OF THE FOLLOWING PRODUCT COMPLAINT, AND WE TRUST THAT YOU WILL TAKE THE APPROPRIATE CORRECTIVE ACTIONS TO RESOLVE THIS ISSUE. THE INFORMATION RELEVANT TO THE COMPLAINT IS AS FOLLOWS: SUPPLIER PRODUCT NUMBER: 305901 SUPPLIER PRODUCT DESCRIPTION: NEEDLE HYPO SAF 25GA 5/8IN QUANTITY INVOLVED: (B)(4) EA LOT# 5295926 SAMPLE AVAILABLE: N IS INVESTIGATION RESPONSE REQUESTED: Y. DATE OF EVENT: 2/2/2026 AFTER ADMINISTERING A SUBCUTANEOUS INJECTION, UPON WITHDRAWAL OF THE NEEDLE FROM THE SUBCUTANEOUS TISSUE, THE NEEDLE DETACHED FROM THE HUB/CANNULA BASE AND REMAINED LODGED IN THE PATIENT'S SUBCUTANEOUS TISSUE. APPROXIMATELY 1 CM OF THE NEEDLE PROTRUDED FROM THE SKIN SURFACE. THE NEEDLE WAS IMMEDIATELY AND SAFELY REMOVED MANUALLY WITHOUT COMPLICATIONS. INTERNAL REF # (B)(4). HB. WAS PATIENT OR END-USER INJURED: N WHEN WAS INCIDENT NOTICED: DURING USE WAS INCIDENT DISCOVERED DURING DIRECT PATIENT CARE: Y WAS ANY MEDICAL TREATMENT REQUI

  Patient problems: Foreign Body In Patient

  MAUDE report 24671066 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. 25G 5/8 IN. NEEDLE CAME APART FROM THE HUB WHEN GIVING AN INJECTION TO INFANT. MEDICATION ADMINISTERED AND WHEN REMOVING FROM THE THIGH THE NEEDLE SEPARATED FROM THE HUB AND REMAINED IN PLACE. IT DID NOT STAY INTACT WITH THE SYRINGE AND SAFETY COVER. STAFF WAS ABLE TO REMOVE NEEDLE FROM THIGH, WITH NO RETAINED EQUIPMENT. USED WITH BD 1 ML SYRINGE WITH LEUR-LOK TIP, LOT # 5260229 AND EXPIRATION DATE OF 8-31-2030.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318286 ↗
• MalfunctionJan 22, 2026Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148990 ↗
• MalfunctionJan 21, 2026Break

  I WAS GIVING A VACCINE; THE NEEDLE CAME RIGHT OUT OF THE PLASTIC CASE AND THE NEEDLE ITSELF STAYED IN THE INFANT. I HAD TO PULL IT OUT OF THE SKIN. (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130331 ↗
• MalfunctionJan 20, 2026Activation Problem

  IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 25X5/8 RB SAFETY MECHANISM BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305901 BATCH#: 5301004. THE NURSE ADMINISTERED THE MEDICATION AND WHEN SHE ATTEMPTED TO ENGAGE THE SAFETY MECHANISM, SHE NOTED THAT THE PLASTIC ON THE SAFETY GUARD WAS BROKEN AND THE NEEDLE WAS NO LONGER ATTACHED TO THE SYRINGE. THE 25-GAUGE SQ NEEDLE WAS IN THE INJECTION SITE (ABDOMEN) OF THE PATIENT. A SECOND NEEDLE WAS DEFECTIVE; THE NEEDLE DIDN'T RELEASE BUT WHEN ENGAGING SAFETY IT BENT IN HALF. 305901, 5301004.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115295 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #:305901 BATCH#:5301004 VERBATIM: SUBQ NEEDLE MALFUNCTION UPON ADMINISTRATION. RN DREW UP ATROPINE AS ORDERED WITH RED BLUNT FILL NEEDLE. SWITCHED NEEDLE TO SUBQ NEEDLE PER STANDARD PROCESS FOR INJECTION ADMINISTRATION. DRUG GIVEN IN ENTIRETY AND RN WENT TO INITIATE SAFETY MECHANISM ON NEEDLE BEFORE DISPOSAL. NEEDLE DETACHED FROM DEVICE AT SYRINGE END OF NEEDLE AND REMAINED IN PATIENT¿S ABDOMEN STICKING OUT. RN THEN HAD TO CAREFULLY PULL BARE NEEDLE FROM PATIENT¿S ABDOMEN FOR DISPOSAL AS IT WAS NO LONGER ATTACHED TO THE REST OF THE SAFETY DEVICE. VERIFIED AGAIN THAT NEEDLE WAS NOT EXPIRED AND STILL WITHIN DATE FOR APPROPRIATE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23984927 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X5/8 RB 305901 NEEDLE PULLED OUT OF HUB. AFTER ADMINISTERING A FLU VACCINE TODAY, (B)(6) 2025, I PROCEEDED TO ACTIVATE THE SAFETY ON THE NEEDLE. WHEN TOUCHING THE BOTTOM OF THE SAFETY FEATURE, THE NEEDLE CAME OFF OF IT'S "HUB". THE NEEDLE WAS A 25 GAUGE 5/8". NO INJURY OCCURRED; HOWEVER, I AM REPORTING THIS INCIDENT TO THE MANUFACTURER AS WAS INSTRUCTED IN THE RECALL OF THE 1" NEEDLES. I AM ALSO NOTIFYING MY PRACTICE AND REGIONAL MANAGERS. LOT# 5214203 EXP 7/31/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921722 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT BD 305901 NEEDLE SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF HUB. VERBATIM: IT WAS THE BD SAFETYGLIDE NEEDLE REF# 305901 LOT# 5080421. THE NEEDLE WAS INSERTED INTO A VIAL. WHEN THE NEEDLE WAS BEING REMOVED FROM THE VIAL, THE NEEDLE SEPARATED FROM THE HUB. NO PATIENT WAS HARMED. THE NEEDLE WAS PUT IN A SHARPS CONTAINER, BUT WE HAVE RETAINED THE HUB AND PACKAGING FOR INSPECTION IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908944 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951254. One submission often covers many models, so check the product and lot details in each record.

• Z-2889-2020 · Jul 28, 2020 · Terminated
  BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
• Z-0315-2018 · Jul 5, 2017 · Terminated
  SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.
• Z-3116-2017 · Jun 13, 2017 · Terminated
  BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from
• Z-2748-2017 · Sep 16, 2016 · Terminated
  BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below th