Food, drugs, devices › Becton Dickinson & Company
Device recall: BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid
FDA enforcement event 77639 is a device recall by Becton Dickinson & Company of Franklin Lakes, NJ, initiated 31 May 2017 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 28 Jun 2018. Initiation: voluntary: firm initiated. Becton Dickinson & Company has 84 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Becton Dickinson & Company, Franklin Lakes, NJ.
Reason for recall
"Hub damage resulting in breakage and/or leakage during use."
Distribution
"Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0207-2018 | BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection. | 2,598,000 units | Class II | Terminated | 13 Dec 2017 |
Context
Other enforcement events for Becton Dickinson & Company
All 84 events for Becton Dickinson & Company
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Hub damage resulting in breakage and/or leakage during use."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 Jun 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.