BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref… recallZ-1109-2021 · Becton Dickinson & Company · initiated Dec 23, 2020
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 Becton Dickinson & Company 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
The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe.
FDA root cause category: Process control
What the company is doing
On 01/13/2020 BD issued an Urgent Medical Device Recall notices to distributors via letters and via e-mail. Distributors are requested to identify their customers and provide BD a customer list so that BD can undertake further communication to the users. BD will distribute the recall communication to the distributors customers via FedEx upon receiving the customer information from the distributors. A copy of the BD product recall customer letter will be provided to distributors, in the case they opt to contact their customers directly.
Recall details
- Recall number
- Z-1109-2021
- Status
- Terminated
- Initiated by the company
- Dec 23, 2020
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 155,200 needles
- Product code
- FMF
- FDA submissions
- K980987
- Distribution
- Distribution US nationwide and Canada
Product description
BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
Code information (models, lots, serial numbers)
Catalog (Ref No.) 305482 100/package UDI 00382903054824 Lot # 8142303 exp date 31-May-2023
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- 10 mL BD Syringe Slip Tip 305482Becton, Dickinson And Company · Syringe, piston1 recall3 reports
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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