BD Safety-Lok 305553Recalls & reported problems
Becton, Dickinson And Company · SYRINGE SAFETYLOK 1ML W/NDL 27X1/2 · Class 2
All models of BD Safety-Lok (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382903055531), received between Nov 27, 2017 and Nov 27, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 18, 2026.
Most reported problems
Device problems
- Device Markings/Labelling Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2017Device Markings/Labelling Problem
IT WAS REPORTED THAT THE 1 ML BD SAFETY-LOK¿ TUBERCULIN SYRINGE WITH 27 G X 1/2 IN. PERMANENTLY ATTACHED NEEDLE HAD SCALE MARKING ISSUES AND APPEARED TO HAD CROOKED MARKINGS. FOUND DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTIONS NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7060057 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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