CLASS II Device recall · Reported 31 Jul 2019 · FDA Enforcement Report
Safety-Lok Syringe recalled by Becton Dickinson &
Becton Dickinson & is recalling Safety-Lok Syringe, distributed in 13 states. The recall was initiated on 1 Feb 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2008-2019
- FDA event ID
- 82138
- Recalling firm
- Becton Dickinson &, Franklin Lakes, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Feb 2019
- FDA classified
- 22 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 1 Feb 2019 | Recall initiated by company | |
| 22 Jul 2019 | Classified by FDA | +171 days |
| 31 Jul 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.
Product as listed by the FDA
3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
Where it was distributed
The products were distributed to the following US states: FL, IL, KS, MA, ND, NH, NY, OH, PA, RI, SC, VA, and WI. The products were distributed to the following foreign countries: Suriname.
FloridaIllinoisKansasMassachusettsNorth DakotaNew HampshireNew YorkOhioPennsylvaniaRhode IslandSouth CarolinaVirginiaWisconsin
Questions about this recall
Is Safety-Lok Syringe recalled?
Yes. Becton Dickinson & recalled Safety-Lok Syringe on 1 Feb 2019. The recall is Class II and its status is Terminated. Recall number Z-2008-2019.
Why was it recalled?
The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.
Which lots are affected?
Lot Number 8307694
Where was it sold?
The products were distributed to the following US states: FL, IL, KS, MA, ND, NH, NY, OH, PA, RI, SC, VA, and WI. The products were distributed to the following foreign countries: Suriname.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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