BD Nano 2nd Gen 320550Recalls & reported problems
Becton Dickinson Pen Limited · BD Nano 2nd Gen Pen Needles, 4mm, 32G, 5bevel, UTW · Class 2
All models of BD Nano 2nd Gen (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Nano 2nd Gen pen needle, used with insulin pens, has 1,892 adverse event reports on record, with no deaths and 23 injuries. Most reports describe medication not flowing through the needle, with needles clogging during injection, not attaching to the pen, and sometimes breaking or leaking. There were no reports in the last 12 months, compared with 123 in the year before. 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
- 2,044
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,044 adverse event reports that list this exact device (DI 00382903205509), received between Sep 12, 2019 and Sep 30, 2026 — classified as 23 injuries, 2,021 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (1,340 reports).
2 other recalls cover devices cleared under the same FDA submission (K212015); 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. 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
- Failure to Deliver1,340
- Misconnection171
- Complete Blockage129
- Break122
- Leak/Splash109
- Defective Device91
- Failure to Prime48
- Defective Component39
Patient problems
- No Clinical Signs, Symptoms or Conditions1,764
- No Consequences Or Impact To Patient158
- No Known Impact Or Consequence To Patient51
- Pain36
- Hyperglycemia33
- Foreign Body In Patient17
- Bruise/Contusion8
- Skin Inflammation/ Irritation8
Recent adverse event reports
The 25 most recent of 2,044 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954932 ↗MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954826 ↗MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954790 ↗MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954703 ↗MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954654 ↗MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954533 ↗MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954025 ↗MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953587 ↗MalfunctionSep 30, 2026Misconnection; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950723 ↗MalfunctionSep 30, 2026Misconnection; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950543 ↗MalfunctionSep 30, 2026Misconnection; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950094 ↗MalfunctionSep 30, 2026Misconnection; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949991 ↗MalfunctionSep 30, 2026Misconnection; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949900 ↗MalfunctionSep 30, 2026Misconnection; Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949338 ↗MalfunctionSep 30, 2026Failure to Deliver
Consumer Reported found about 2 dozen pen needles from two different lot number. Unknown amount on each lot #. Needles would not prime. noticed after removed from pen the non patient end needle to be bent. DC Lot # 3017179 Lot # 3025239Catalog# unknown - 32g 4mm 2nd gen Date of Event Unknown Sample Status Awaiting sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943940 ↗MalfunctionSep 30, 2026Failure to Deliver
Consumer Reported found about 2 dozen pen needles from two different lot number. Unknown amount on each lot #. Needles would not prime. noticed after removed from pen the non patient end needle to be bent. DC.Lot # 3017179.Lot # 3025239.Catalog# unknown - 32g 4mm 2nd gen. Date of Event Unknown. Sample Status Awaiting sample.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943781 ↗MalfunctionSep 30, 2026Failure to Deliver
Consumer Reported found about 2 dozen pen needles from two different lot number. Unknown amount on each lot #. Needles would not prime. noticed after removed from pen the non patient end needle to be bent. DC Lot # 3017179 Lot # 3025239Catalog# unknown - 32g 4mm 2nd gen Date of Event Unknown Sample Status Awaiting sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943671 ↗MalfunctionSep 30, 2026Failure to Deliver
Consumer Reported found about 2 dozen pen needles from two different lot number. Unknown amount on each lot #. Needles would not prime. noticed after removed from pen the non patient end needle to be bent. DC Lot # 3017179 Lot # 3025239Catalog# unknown - 32g 4mm 2nd gen Date of Event Unknown Sample Status Awaiting sample.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943594 ↗MalfunctionSep 30, 2026Defective Device
Consumer left voicemail reporting defective needles. Rep returned his call and left voicemail requesting return call. Consumer returned call and reported that needle is protruding through the green inner shield. He stated that he has 17 pen needles where the needle came through the inner shield. Consumer stated that he stuck his finger with the needles a few times.I asked consumer about re-shielding after use and he said that he does not re-shield with the green cover but he prepares the insulin and puts it into the refrigerator for use when it is time to take his injection. Consumer is new to using pen needles and did not seem very sure of how to use. He stated that he does not re-use.Lot #: 3276406.Catalog #: 320550.Date of Event: unknown.Samples available: sending mail kit.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943420 ↗MalfunctionSep 30, 2026Defective Device
Consumer left voicemail reporting defective needles. Rep returned his call and left voicemail requesting return call. Consumer returned call and reported that needle is protruding through the green inner shield. He stated that he has 17 pen needles where the needle came through the inner shield. Consumer stated that he stuck his finger with the needles a few times.I asked consumer about re-shielding after use and he said that he does not re-shield with the green cover but he prepares the insulin and puts it into the refrigerator for use when it is time to take his injection. Consumer is new to using pen needles and did not seem very sure of how to use. He stated that he does not re-use.Lot #: 3276406Catalog #: 320550Date of Event: unknownSamples available: sending mail kit.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943419 ↗MalfunctionSep 30, 2026Defective Device
Consumer left voicemail reporting defective needles. Rep returned his call and left voicemail requesting return call. Consumer returned call and reported that needle is protruding through the green inner shield. He stated that he has 17 pen needles where the needle came through the inner shield. Consumer stated that he stuck his finger with the needles a few times.I asked consumer about re-shielding after use and he said that he does not re-shield with the green cover but he prepares the insulin and puts it into the refrigerator for use when it is time to take his injection. Consumer is new to using pen needles and did not seem very sure of how to use. He stated that he does not re-use.Lot #: 3276406.Catalog #: 320550.Date of Event: unknown.Samples available: sending mail kit.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943410 ↗MalfunctionSep 30, 2026Break
Consumer Reported found from this box only 30 pen needles that broke off into different injection sites. Stomach Leg and arm.Wife able to remove the needle with a tweezer each time.Denied reuse of needles. does not pinch up site. Before this box always used the BD 8mm pen needles. DCLot # 2333537Catalog# 320550Date of Event unknownDate of event 04.29.2029Sample Status Awaiting sample unused from this box
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943343 ↗MalfunctionSep 30, 2026Break
Consumer Reported found from this box only 30 pen needles that broke off into different injection sites. Stomach Leg and arm.Wife able to remove the needle with a tweezer each time.Denied reuse of needles. does not pinch up site. Before this box always used the BD 8mm pen needles. DCLot # 2333537Catalog# 320550Date of Event unknownDate of event 04.29.2029Sample Status Awaiting sample unused from this box
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943273 ↗MalfunctionSep 30, 2026Failure to Deliver
Consumer Reported found about 2 dozen pen needles from two different lot number. Unknown amount on each lot #. Needles would not prime. noticed after removed from pen the non patient end needle to be bent. DC Lot # 3017179 Lot # 3025239Catalog# unknown - 32g 4mm 2nd gen Date of Event Unknown Sample Status Awaiting sample.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943240 ↗MalfunctionSep 30, 2026Break
Consumer Reported found from this box only 30 pen needles that broke off into different injection sites. Stomach Leg and arm.Wife able to remove the needle with a tweezer each time.Denied reuse of needles. does not pinch up site. Before this box always used the BD 8mm pen needles. DCLot # 2333537Catalog# 320550Date of Event unknownDate of event 04.29.2029Sample Status Awaiting sample unused from this box.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943155 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K212015. One submission often covers many models, so check the product and lot details in each record.
- Z-2424-2024 · Jun 18, 2024 · Open, ClassifiedBD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for
- Z-3179-2026 · Jul 26, 2023 · Open, ClassifiedEWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
Other Needle, hypodermic, single lumen devices
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
- BD Safety-Lok 305901Becton, Dickinson And Company · Needle, hypodermic, single lumen176 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