BD Microtainer® Contact-Activated Lancet 366593Recalls & reported problems
Becton, Dickinson And Company · LANCET CONT-ACT PINK 21G X 1.8MM · Class 2
All models of BD Microtainer Contact-Activated Lancet (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Microtainer contact-activated lancet is a small needle used to prick the skin for blood sampling. The 89 reports mostly describe the lancet failing to retract and leaving the blade exposed, along with contamination, activation problems, and packaging issues; there are 11 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 89
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 30382903665939), received between Oct 30, 2017 and Apr 21, 2026 — classified as 11 injuries, 78 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (18 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, 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.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material18
- Defective Device10
- Difficult or Delayed Activation10
- Delivered as Unsterile Product8
- Product Quality Problem8
- Packaging Problem7
- Break6
- Retraction Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- No Known Impact Or Consequence To Patient24
- Needle Stick/Puncture6
- No Consequences Or Impact To Patient3
- Pain3
- Device Embedded In Tissue or Plaque2
- No Information2
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2026Material Separation
IT WAS REPORTED THAT AFTER A BLOOD COLLECTION PROCEDURE USING BD MICROTAINER CONTACT ACTIVATED LANCET, ONE PATIENT FELT THE SENSATION OF A FOREIGN BODY AND PAIN. A PHYSICIAN EXAMINED THE PATIENT AND DETERMINED THE CAUSE UNKNOWN AND BY THIS TIME, THE PAIN HAD SUBSIDED. AT A LATER DATE, THE PATIENT SELF EXCISED THE RAISED AREA OF SKIN AND BROUGHT THE SPECIMEN TO THE FACILITY. THERE IS NO REPORT OF ADDITIONAL MEDICAL INTERVENTION OR TREATMENT.
Patient problems: Foreign Body In Patient
MAUDE report 24945094 ↗MalfunctionJan 6, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT WHEN USING ONE (1) BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE UNIT FAILED TO RETRACT AFTER PRESSING THE BUTTON. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23974029 ↗MalfunctionDec 22, 2025Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT AFTER USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23870661 ↗MalfunctionNov 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AFTER USING ONE (1) BD MICROTAINER® CONTACT-ACTIVATED LANCET, IT WAS SUSPECTED THAT THERE WAS FOREIGN MATERIAL IN THE FINGER WHERE THE LANCET WAS USED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23464333 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT WHEN USING ONE (1) BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE PATIENT EXPERIENCED INCREASED PAIN, AND A BROKEN LANCET BLADE IN THE PATIENT'S FINGER WAS SUSPECTED. EXAMINATION OF THE SITE REVEALED NO BROKEN LANCET BLADE IN THE PATIENT'S FINGER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23425378 ↗MalfunctionOct 16, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT AFTER USING ONE (1) BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE BLADE DID NOT RETRACT AND REMAINED EXPOSED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23310480 ↗MalfunctionJun 9, 2025Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT WHEN USING ONE (1) BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE LANCET BLADE WOULD NOT RETRACT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22167449 ↗MalfunctionMar 17, 2025Premature Separation; Premature Separation
IT WAS REPORTED THAT PRIOR TO USING BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE PROTECTIVE CAP OF AN UNSPECIFIED NUMBER OF DEVICES COMES OFF EXPOSING NEEDLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21620855 ↗MalfunctionJul 9, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED AFTER USING A BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE BLADE DID NOT RETRACT BACK INTO THE HOUSING. NO IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19703408 ↗MalfunctionJun 28, 2024Break; Material Deformation; Mechanical Jam; Break; Material Deformation; Mechanical Jam
IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE IN THE OCCLUDED LEFT LOWER EXTREMITY FEMORAL ARTERY VIA THE RIGHT FEMORAL ARTERY, THE WASTE LIQUID BAG WAS ALLEGEDLY FOUND TO HAVE NO LIQUID REFLUX DURING THE SUCTION PROCESS. IT WAS FURTHER REPORTED THAT AFTER THE CATHETER WAS WITHDRAWN, THE SPRING AT THE TIP OF THE CATHETER WAS ALLEGEDLY FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19632428 ↗InjuryJun 8, 2024Defective Device; Defective Device
IT WAS REPORTED AFTER USING A BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE PATIENT COMPLAINED OF FINGER PAIN, REDNESS, AND SWELLING. THE PATIENT WONDERED IF THE BLADE BROKE IN THEIR FINGER. THE DOCTOR DIAGNOSED NERVE DAMAGE.
Patient problems: Nerve Damage
MAUDE report 19494001 ↗MalfunctionMay 20, 2024Break; Break
IT WAS REPORTED WHILE USING BD MICROTAINER® CONTACT-ACTIVATED LANCETS, THE FIRST LANCET USED DID NOT GIVE SUFFICIENT BLOOD FLOW SO A SECOND LANCET WAS USED. THE PATIENT REPORTED FINGER PAIN AND STAFF NOTICED SOME SKIN ON THE LANCET BUT DID NOT OBSERVE ANY OTHER ABNORMALITIES. LATER ON, THE PATIENT HAD A RED AND SWOLLEN FINGER. THEY FOUND A PIECE OF THE LANCET BLADE INSIDE THE INCISION. THE PATIENT REMOVED THE PIECE OF THE BLADE THEMSELVES. NO MEDICAL INTERVENTION WAS NECESSARY. NO FURTHER IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19353969 ↗MalfunctionApr 12, 2024Defective Device; Defective Device
IT WAS REPORTED WHEN USING BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE LANCET HOUSING BROKE APART. ANOTHER DEVICE WAS USED TO COMPLETE THE COLLECTION. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19098389 ↗MalfunctionMar 28, 2024Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion; Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion
IT WAS REPORTED THAT WHILE USING BD MICROTAINER® CONTACT-ACTIVATED LANCET THAT MULTIPLE DEFECTS WERE IDENTIFIED. THE CUSTOMER DISCOVERED LANCETS WITH FOREIGN MATTER, ASSEMBLY DEFECTS, MOLDING DEFECTS, CRACKS, AND DISCOLORATION. THE DEFECTS WERE DISCOVERED PRIOR TO USE, AND NO IMPACT TO PATIENTS WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18990432 ↗MalfunctionJan 12, 2024Product Quality Problem; Device Contamination with Chemical or Other Material; Product Quality Problem; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHILE USING BD MICROTAINER® CONTACT-ACTIVATED LANCET, THERE WERE MULTIPLE INSTANCES OF LOOSE CAPS AND EMBEDDED FOREIGN MATTER SEEN ACROSS TWO KNOWN LOT NUMBERS AND ONE UNKNOWN LOT NUMBER. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18507934 ↗MalfunctionDec 22, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO USING BD MICROTAINER® CONTACT-ACTIVATED LANCET, THERE WERE BLACK DOTS AND STAINS FOUND ON THE DEVICES. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18387021 ↗InjuryDec 15, 2023Product Quality Problem; Difficult or Delayed Activation; Premature Separation; Product Quality Problem; Difficult or Delayed Activation; Premature Separation
IT WAS REPORTED THAT BD MICROTAINER® CONTACT-ACTIVATED LANCET, NEEDLE TIP DOES NOT REBOUND, RESULTING IN NEEDLESTICK INJURY POST-USE. THIS HAS OCCURRED THREE TIMES. NO ADDITIONAL INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18335678 ↗MalfunctionOct 24, 2023Defective Device; Defective Device
IT WAS REPORTED THAT DURING USE WITH 2 BD MICROTAINER® CONTACT-ACTIVATED LANCET THE LANCET PULLED OUT OF THE DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON OCTOBER 10, THE TEACHER OF THE OUTPATIENT LABORATORY DEPARTMENT INFORMED THAT THERE WAS A QUALITY PROBLEM IN THE PROCESS OF COLLECTING PERIPHERAL BLOOD. WHEN I WENT TO THE SCENE, I FOUND THAT WHEN A NEEDLE WAS OPENED, IT WAS IN A BROKEN STATE, AND THE PINK PART HAD A DEFECT SIMILAR TO MELTING, AND IT FELL APART AFTER HOLDING IT. WHEN A NEEDLE IS USED, IT IS DIRECTLY PULLED OUT TOGETHER WITH THE PUNCTURE NEEDLE, AND THE PUNCTURE NEEDLE PULLED OUT AT THE SAME TIME IS THE TIP IS EXPOSED, AND IT IS SUSPECTED THAT THE PUNCTURE NEEDLE IS INSTALLED BACKWARDS. THE SCENE AND THE TEACHER DISASSEMBLED A NORMAL BLOOD COLLECTION DEVICE FOR COMPARISON, AND FOUND THAT THE PUNCTURE NEEDLE IN QUESTION WAS INDEED INSTALLED BACKWARDS, PLEASE HELP CONFIRM THIS PROBLEM. THE NEEDLE WAS PULLED OUT AND INSTALLED BACKWARDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17999219 ↗MalfunctionSep 28, 2023Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT PRIOR TO USE WITH BD MICROTAINER® CONTACT-ACTIVATED LANCET THE LANCET BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE PATIENT REPORTED THAT THE NEEDLE (BLADE) CAME OFF FROM THE BODY OF THE PRODUCT BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17839469 ↗MalfunctionSep 26, 2023Material Separation; Material Separation
IT WAS REPORTED THAT PRIOR TO USE WITH 2 BD MICROTAINER® CONTACT-ACTIVATED LANCET THE PROTECTIVE CAP IS LOOSE AND FALLS OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: CAP OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17818590 ↗MalfunctionSep 22, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD MICROTAINER® CONTACT-ACTIVATED LANCET FOREIGN MATTER WAS DISCOVERED ON DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: COMPLAINT DETAILS: BLACK SPOTS, STAINS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17804769 ↗MalfunctionSep 22, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD MICROTAINER® CONTACT-ACTIVATED LANCET MOLDING DEFECTS "BURRS" WERE DISCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: BURRS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17801383 ↗MalfunctionAug 10, 2023Break; Separation Problem; Break; Separation Problem
IT WAS REPORTED WHEN USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET DURING THE PROCESS OF COLLECTING PERIPHERAL BLOOD, THE DEVICES WERE BROKEN IN HALF WHEN THE PACKAGE WAS OPENED, AND ONE BLOOD COLLECTION DEVICE WAS PULLED OUT TOGETHER WITH THE PUNCTURE NEEDLE DURING USE. THIS EVENT OCCURRED 198 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE TEACHER OF THE LABORATORY DEPARTMENT OF THE OUTPATIENT CLINIC INFORMED THAT DURING THE PROCESS OF COLLECTING PERIPHERAL BLOOD, THERE WERE PROBLEMS SUCH AS INSUFFICIENT PUNCTURE DEPTH IN FEN TOUCH. BY OBSERVING THE OPERATION PROCESS OF THE BLOOD COLLECTION TEACHER IN THE OUTPATIENT CLINIC, IT WAS FOUND THAT A LARGE NUMBER OF PROBLEMATIC BLOOD COLLECTION NEEDLES CONTINUED TO APPEAR. AT THE SAME TIME, A FEW BLOOD COLLECTION DEVICES WERE BROKEN IN HALF WHEN THE PACKAGE WAS OPENED, AND ONE BLOOD COLLECTION DEVICE WAS PULLED OUT TOGETHER WITH THE PUNCTURE NEEDLE WHEN IT WAS IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17503243 ↗MalfunctionJun 30, 2023Crack; Solder Joint Fracture; Device Contamination with Chemical or Other Material; Material Deformation; Crack; Solder Joint Fracture; Device Contamination with Chemical or Other Material; Material Deformation
IT WAS REPORTED THAT WHILE USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET THAT THERE WAS FOREIGN MATER ON THE DEVICE NEEDLE, BLADE MOLDING DEFECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HE CUSTOMER RETURNED COMPLAINT PRODUCTS, REPORTING ABOUT SCRATCHED/DIRTY/CRACKED PRODUCTS AND BURRS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17240956 ↗MalfunctionJun 26, 2023Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT BD MICROTAINER® CONTACT-ACTIVATED LANCET HAD THE SPRING AND NEEDLE TIP FALL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHASE: WHEN THE PRODUCT IS IN USE DEFECT; WHEN USING THE PRODUCT, PULL OUT THE NEEDLE PROTECTION CAP, THE SPRING FALLS OFF / WHEN USING THE PRODUCT, PULL OUT THE NEEDLE PROTECTION CAP, THE NEEDLE TIP FALLS OFF QUANTITY: 2. EFFECTS: NO OTHER ADVERSE EFFECTS ON PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17198865 ↗
Other Lancet, blood devices
- BD Microtainer® Contact-Activated Lancet 366594Becton, Dickinson And Company · Lancet, blood64 reports
- OneTouch Ultrasoft 020-393LifeScan Europe GmbH · Lancet, Blood1 recall0 reports
- CARDINAL HEALTH SLMF200Cardinal Health 200, LLC · Lancet, blood16 reports
- BD Microtainer® Contact-Activated Lancet 366592Becton, Dickinson And Company · Single use only blood lancet with an integral sharps injury prevention feature14 reports
- Medline MPHSFTY28Medline Industries, Inc. · Single use only blood lancet with an integral sharps injury prevention feature6 reports
- Unistik Touch AT 1444Owen Mumford Limited · Lancet, Blood4 reports
- Unistik 3 AT 1012Owen Mumford Limited · Lancet, Blood3 reports
- BD Microtainer® QuikHeel™ Lancet 368101Becton, Dickinson And Company · Single use only blood lancet with an integral sharps injury prevention feature3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page