Z-0898-2015Class II

Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010

Name: Z-0898-2015 Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010
Creator: Smiths Medical ASD, Inc.
Published: 2014-11-21
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-11-21 / Completed / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro Edge Safety... on 2014-11-21. FDA classified it as Class II and gives the reason as "Needle is not captured in the needle safety sheath in specific lots". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0898-2015
Classification: Class II
Status: Completed
Initiated: 2014-11-21
Posted: 2014-12-30
Recalling firm: Abbott Medical
Product: Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Needle is not captured in the needle safety sheath in specific lots.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Smith Medical sent on 11/24/2014, consignees an Urgent Field Safety Notice via FedEx Overnight. The notification instructs customers to inspect their inventory and complete and return the attached Urgent Field Safety Notice Confirmation Form to coordinate return of affected product to Smiths Medical for replacement/credit. For questions regarding this information, please contact Smiths Medicals Customer Service Department at 800-258-5361.
Quantity in commerce: 47,200
Distribution: US Nationwide Distribution in the states of AZ CA FL GA IL IN LA MA MN MO MS MT NC ND NJ NV NY OH OR PA RI TN TX VA WA WI WV
Product codes and lots: Lot Numbers: 2756526, 2771498

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0898-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0897-2015	Class II	Completed	Voluntary: Firm initiated	2015-01-07	2014-12-30
Z-0898-2015	Class II	Completed	Voluntary: Firm initiated	2015-01-07	2014-12-30
Z-0899-2015	Class II	Completed	Voluntary: Firm initiated	2015-01-07	2014-12-30

Product code FMI

K041399Class IIHypodermic Needle-Pro Edge Needle Protection DeviceSmiths Medical Asd, Inc. / cleared 2004-07-28

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)