BD Safety-Lok 309596Recalls & reported problems
Becton, Dickinson And Company · SYRINGE SAFETYLOK 3ML LL W/NDL 22X1 · Class 2
All models of BD Safety-Lok (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30382903095965), received between Feb 15, 2018 and May 15, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Aspiration Issue” (1 report).
1 other recall cover devices cleared under the same FDA submission (K944757); 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 16, 2026.
Most reported problems
Device problems
- Aspiration Issue1
- Device Markings/Labelling Problem1
- Retraction Problem1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2018Retraction Problem; Aspiration Issue
IT WAS REPORTED THERE WAS DIFFICULT PLUNGER MOVEMENT FOUND WHILE USING A 3 ML BD SAFETY-LOK¿ SYRINGE WITH DETACHABLE NEEDLE AS THE CONSUMER STATED "THE SYRINGE DID NOT DRAW UP THE MEDICATION." THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7515014 ↗MalfunctionFeb 15, 2018Device Markings/Labelling Problem
IT WAS REPORTED THAT BD SAFETY-LOK¿ SYRINGE WITH DETACHABLE NEEDLE HAD SCALE MARKING ISSUES FOUND BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7275227 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K944757. One submission often covers many models, so check the product and lot details in each record.
- Z-2008-2019 · Feb 1, 2019 · Terminated3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- 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
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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