BD Safety-LokRecalls & reported problems across all models
Becton, Dickinson And Company · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 360
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 0
We found 14 models of BD Safety-Lok by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 360 adverse event reports in the FDA's MAUDE database, received between Nov 6, 2017 and Sep 16, 2026 — classified as 17 injuries, 343 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (60 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BD Safety-Lok problems
Device problems
- Leak/Splash60
- Complete Blockage48
- Break40
- Detachment of Device or Device Component35
- Device Contamination with Chemical or Other Material27
- Material Protrusion/Extrusion18
- Defective Component16
- Material Separation16
Patient problems
- No Clinical Signs, Symptoms or Conditions187
- No Known Impact Or Consequence To Patient94
- Needle Stick/Puncture25
- No Consequences Or Impact To Patient20
- No Patient Involvement9
- Insufficient Information8
- Foreign Body In Patient7
- No Information7
BD Safety-Lok models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Safety-Lok 305901Needle, hypodermic, single lumen176 reports
- BD Safety-Lok 305902Needle, hypodermic, single lumen107 reports
- BD Safety-Lok 305900Needle, hypodermic, single lumen31 reports
- BD Safety-Lok 309606Needle, hypodermic, single lumen21 reports
- BD Safety-Lok 309592Needle, hypodermic, single lumen9 reports
- BD Safety-Lok 305559Needle, hypodermic, single lumen3 reports
- BD Safety-Lok 309593Needle, hypodermic, single lumen3 reports
- BD Safety-Lok 305564Needle, hypodermic, single lumen2 reports
- BD Safety-Lok 309594Needle, hypodermic, single lumen2 reports
- BD Safety-Lok 309596Needle, hypodermic, single lumen2 reports
- BD Safety-Lok 305553Needle, hypodermic, single lumen1 report
- BD Safety-Lok 305558Needle, hypodermic, single lumen1 report
- BD Safety-Lok 305561Needle, hypodermic, single lumen1 report
- BD Safety-Lok 309595Needle, hypodermic, single lumen1 report
Recent BD Safety-Lok adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionSep 10, 2026Material Twisted/Bent
Two needles from the same lot number bent when trying to inject medication to a patient struggling against restraint. Needle bent on contact with patient skin, not when needle was in the patient's body. The first needle bent on "[redacted]" when trying to inject the patient and the second needle bent on "[redacted]"-the next day when trying to inject the same patient. The first needle bent at a 90- degree angle and the second needle bent in a curved fashion. Proper intramuscular injection technique was maintained (injecting at a 90-degree angle, securing and isolating the muscle, physical hold applied correctly). Both times required a second physical hold and delayed treatment of the patient as a second needle needed to be obtained for medication administration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713853 ↗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 9, 2026Break
IT WAS REPORTED THAT BD NEEDLE SFTYGLD 23X1 RB NEEDLE PULLED OUT OF HUB. COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PER (B)(6) DURING A VACCINE INJECTION THE NEEDLE SEPARATED FROM THE HUB AND WAS LEFT IN THE PATIENT'S LEG. NO STRUGGLE/ISSUE WITH SHOT. IT JUST HAD SEPARATED AND LEFT NEEDLE IN THE LEG. HSI CONTROL NUMBER: 129056 HSI DESCRIPTION: SAFETYGLIDE NEEDLE HSI ITEM NUMBER: US_9875902 HSI MANUFACTURER PART NUMBER: 305902 HSI LOT OR SERIAL NUMBER: (B)(6).
Patient problems: Insufficient Information
MAUDE report 24831054 ↗
Other Becton, Dickinson And Company products
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- BD Insyte Autoguard33 models · 4,465 reports · 8 recalls
- BD SafetyGlide17 models · 2,185 reports
- BD Vacutainer Eclipse Blood Collection Needle4 models · 1,880 reports
- BD Vacutainer Push Button Blood Collection Set9 models · 1,831 reports
- BD Nexiva25 models · 1,614 reports · 1 recall
- BD BACTEC MGIT Mycobacteria Growth Indicator Tubes2 models · 1,554 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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