CLASS II Device recall · Reported 15 Jun 2016 · FDA Enforcement Report
Henry Schein Single Use Syringe Luer-Lock, Intended recalled
Becton Dickinson & is recalling Henry Schein Single Use Syringe Luer-Lock, Intended for use by health care professionals, distributed nationwide in the US. The recall was initiated on 25 Mar 2016 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-1937-2016
- FDA event ID
- 73828
- Recalling firm
- Becton Dickinson &, Franklin Lakes, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Mar 2016
- FDA classified
- 9 Jun 2016
- Reported
- 15 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 25 Mar 2016 | Recall initiated by company | |
| 9 Jun 2016 | Classified by FDA | +76 days |
| 15 Jun 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.
Product as listed by the FDA
Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
Where it was distributed
Nationwide Distribution to NY only
Questions about this recall
Is Henry Schein Single Use Syringe Luer-Lock, Intended for use by health care professionals recalled?
Yes. Becton Dickinson & recalled Henry Schein Single Use Syringe Luer-Lock, Intended for use by health care professionals on 25 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1937-2016.
Why was it recalled?
BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.
Which lots are affected?
Catalog (REF #) 309642, Lot #'s 4163814, 4252723, 4252726, 4252729, 4293878, 4340516, 5017729 and 5017735
Where was it sold?
Nationwide Distribution to NY only
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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