Z-0207-2018Class II

BD Precision Glide Needle 18G x 1 RB, Catalog 305195

Name: Z-0207-2018 BD Precision Glide Needle 18G x 1 RB, Catalog 305195
Creator: Becton Dickinson & Company
Published: 2017-05-31
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2017-05-31 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion... on 2017-05-31. FDA classified it as Class II and gives the reason as "Hub damage resulting in breakage and/or leakage during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0207-2018
Classification: Class II
Status: Terminated
Initiated: 2017-05-31
Posted: 2017-12-07
Terminated: 2018-06-28
Recalling firm: Becton Dickinson & Co
Product: 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.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Hub damage resulting in breakage and/or leakage during use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 31, 2017 BD distributed Urgent Medical Device Recall notices and Business Response Cards to their customers. Customers were advised to immediately review their inventory for the specific Catalog (Ref) and lot number, discontinue use of and quarantine the affected item. Complete and return the Business Response Card form via fax to BD 855-544-4803 or email the form to [email protected]. Return all affected products with the completed Business Response Card form following the instruction on the enclosed packing instruction. Upon receipt of the returned product, BD will issue product replacement. Note: If customers do not have any of the affected lots in your inventory, please complete the Business Response Card form indicating you have zero (0) quantity. Customers who have questions or require further assistance with the return of the recalled product, please contact 855-215-4932 between 8AM and 5PM, EST, Monday through Friday.
Quantity in commerce: 2,598,000 units
Distribution: Nationwide Distribution
Product codes and lots: Lot Number: 6152995 Expiration Date: 31-Jul-21

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0207-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0207-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-07

Product code FMI

K021475Class IIBd Single Lumen Needle, Syringe and Blood Collection SetBd / cleared 2002-07-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)