CLASS II Device recall · Reported 6 Jul 2016 · FDA Enforcement Report
Specimen Containers, Screw-On, Leak-Resistant Lid recalled by Dynarex
Dynarex is recalling dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, distributed nationwide in the US. The recall was initiated on 3 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-2057-2016
- FDA event ID
- 73584
- Recalling firm
- Dynarex, Orangeburg, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Mar 2016
- FDA classified
- 27 Jun 2016
- Reported
- 6 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 3 Mar 2016 | Recall initiated by company | |
| 27 Jun 2016 | Classified by FDA | +116 days |
| 6 Jul 2016 | 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
Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection
Where it was distributed
US Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International: Canada
Nationwide AlabamaArkansasFloridaGeorgiaMassachusettsNorth CarolinaNew HampshireNew JerseyNew YorkOhioPennsylvaniaTexasVirginia
Questions about this recall
Is Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single recalled?
Yes. Dynarex recalled Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single on 3 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-2057-2016.
Why was it recalled?
Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
Which lots are affected?
Lot Numbers: 31899, 32014, 32015, 32410 & 32411
Where was it sold?
US Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International: Canada
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.
More recalls from Dynarex
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM recalled | Dynarex | Labeling Errors | MA, NJ |
| Device | CLASS II | CPR Shield With One Way Valve and Barrier Filter recalled by Dynarex | Dynarex | Labeling Errors | NY |
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