CLASS II Device recall · Reported 7 Aug 2019 · FDA Enforcement Report
Acuject Variable Injection Needle recalled by Wilson-Cook Medical
Wilson-Cook Medical is recalling Acuject Variable Injection Needle. The recall was initiated on 14 Jun 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-2089-2019
- FDA event ID
- 83135
- Recalling firm
- Wilson-Cook Medical, Winston Salem, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jun 2019
- FDA classified
- 27 Jul 2019
- Reported
- 7 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 14 Jun 2019 | Recall initiated by company | |
| 27 Jul 2019 | Classified by FDA | +43 days |
| 7 Aug 2019 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for occluded injection needles.
Product as listed by the FDA
Acuject Variable Injection Needle
Where it was distributed
Distributed to China
Questions about this recall
Why was it recalled?
Potential for occluded injection needles.
Which lots are affected?
Lot Code W413079; Catalog Number VIN-25; Expiration Date 10/24/2021; UDI Number (01)00827002225268(17)211024(10)W4136079
Where was it sold?
Distributed to China
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 26 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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