BD Vacutainer Safety-Lok Blood Collection SetRecalls & reported problems across all models
Becton, Dickinson And Company · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 367
- Deaths reported
- 0
- Injuries reported
- 88
- Recalls
- 0
We found 10 models of BD Vacutainer Safety-Lok Blood Collection Set by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 367 adverse event reports in the FDA's MAUDE database, received between Oct 27, 2017 and Sep 16, 2026 — classified as 88 injuries, 279 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (87 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 Vacutainer Safety-Lok Blood Collection Set problems
Device problems
- Leak/Splash87
- Product Quality Problem86
- Difficult or Delayed Activation62
- Fluid/Blood Leak33
- Physical Resistance/Sticking31
- Volume Accuracy Problem27
- Device Markings/Labelling Problem12
- Break10
Patient problems
- No Clinical Signs, Symptoms or Conditions189
- Needle Stick/Puncture85
- No Known Impact Or Consequence To Patient65
- No Consequences Or Impact To Patient18
- Exposure to Body Fluids11
- No Information4
- Bruise/Contusion3
- Blood Loss2
BD Vacutainer Safety-Lok Blood Collection Set models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Vacutainer® Safety-Lok™ Blood Collection Set 367283Tubes, vials, systems, serum separators, blood collection135 reports
- BD Vacutainer® Safety-Lok™ Blood Collection Set 367281Tubes, vials, systems, serum separators, blood collection101 reports
- BD Vacutainer® Safety-Lok™ Blood Collection Set 367287Tubes, vials, systems, serum separators, blood collection31 reports
- BD Vacutainer® Safety-Lok™ Blood Collection Set 367292Tubes, vials, systems, serum separators, blood collection29 reports
- BD Vacutainer® Safety-Lok™ Blood Collection Set 367285Tubes, vials, systems, serum separators, blood collection21 reports
- BD Vacutainer® Safety-Lok™ Blood Collection Set 367297Tubes, vials, systems, serum separators, blood collection20 reports
- BD Vacutainer® Safety-Lok™ Blood Collection Set 367296Tubes, vials, systems, serum separators, blood collection12 reports
- BD Vacutainer® Safety-Lok™ Blood Collection Set 367294Tubes, vials, systems, serum separators, blood collection8 reports
- BD Vacutainer® Safety-Lok™ Blood Collection Set 367288Tubes, vials, systems, serum separators, blood collection7 reports
- BD Vacutainer® Safety-Lok™ Blood Collection Set 367298Tubes, vials, systems, serum separators, blood collection3 reports
Recent BD Vacutainer Safety-Lok Blood Collection Set adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792533 ↗MalfunctionSep 16, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787116 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734676 ↗MalfunctionSep 10, 2026Retraction Problem
It was reported while using BD Vacutainer® Safety-Lok¿ Blood Collection Set, the rubber stopper at the end of three devices did not spring back, resulting in blood leakage. No adverse impact was reported regarding the patient or user.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721207 ↗MalfunctionMay 27, 2026Fluid/Blood Leak
IT WAS REPORTED THAT DURING BLOOD DRAW OF ONE PATIENT USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, BLOOD LEAKED FROM THE RUBBER SLEEVE OF ONE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25302616 ↗MalfunctionMay 20, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, 5 DEVICES HAD POOR SLEEVE FUNCTION AND LEAKED BLOOD FROM THE NP CANNULA. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231967 ↗MalfunctionMay 12, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, 1 DEVICE EXHIBITED POOR SLEEVE FUNCTION AND LEAKED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153518 ↗MalfunctionMay 7, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE PIERCED THE RUBBER SLEEVE OF 10 DEVICES RESULTING IN SAMPLE LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25112694 ↗MalfunctionApr 14, 2026Fluid/Blood Leak; Short Fill; Difficult or Delayed Activation
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, AN UNSPECIFIED NUMBER OF DEVICES EXHIBITED INSUFFICIENT BLOOD FLOW, SAMPLE LEAKAGE FROM A DEFECTIVE RUBBER SLEEVE, AND DIFFICULTY IN ACTIVATING THE SAFETY FEATURE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24879102 ↗MalfunctionApr 13, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE RUBBER SLEEVE FAILED TO RETRACT, CAUSING THE CANNULA TO BECOME EXPOSED AND BLOOD TO LEAK OUT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865219 ↗MalfunctionApr 3, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, RESISTANCE IS SEEN DURING BLOOD DRAW USING AN UNSPECIFIED NUMBER OF DEVICES. WHEN THE NURSE ENGAGES THE YELLOW NEEDLE SHIELD, ANY BLOOD THAT IS IN THE TUBING SHOOTS OUT OF THE NEEDLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778572 ↗MalfunctionMar 30, 2026Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, AN UNSPECIFIED NUMBER OF TUBES WOULD NOT FILL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24733885 ↗MalfunctionMar 12, 2026Material Separation
REPORT 6 OF 6 IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE BROKE IN THE BLOOD COLLECTION TUBE WITH ONE PATIENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24579906 ↗MalfunctionMar 11, 2026Material Separation
REPORT 5 OF 6 IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE BROKE IN THE BLOOD COLLECTION TUBE WITH ONE PATIENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24576609 ↗MalfunctionMar 11, 2026Material Separation
REPORT 4 OF 6 IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE NEEDLE BROKE IN THE BLOOD COLLECTION TUBE WITH ONE PATIENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24572538 ↗
Other Becton, Dickinson And Company products
- BD Vacutainer SST10 models · 4,985 reports · 3 recalls
- BD Luer-Lok48 models · 5,117 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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