AcuJect recallZ-2089-2019 · Wilson-Cook Medical Inc. · initiated Jun 14, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Wilson-Cook Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for occluded injection needles.
FDA root cause category: Employee error
What the company is doing
Wilson-Cook Medical notified their customer on about 06/14/2019 via "URGENT: MEDICAL DEVICE RECALL" letter. The letter instructed customers to examine inventory for affected devices, quarantine any affected devices, notify customers if the product has been further distributed, and return affected devices to Cook China as soon as possible. The customer was also instructed to complete the provided Recall Return Response form and send it to Cook China.
Recall details
- Recall number
- Z-2089-2019
- Status
- Terminated
- Initiated by the company
- Jun 14, 2019
- Recalling firm
- Wilson-Cook Medical Inc.
- Quantity
- 24
- Product code
- FBK
- FDA submissions
- K941305
- Distribution
- Distributed to China
Product description
Acuject Variable Injection Needle
Code information (models, lots, serial numbers)
Lot Code W413079; Catalog Number VIN-25; Expiration Date 10/24/2021; UDI Number (01)00827002225268(17)211024(10)W4136079
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AcuJect G22526Cook Incorporated · endoscopic injection needle, gastroenterology-urology1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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