Hypodermic Needle Pro Edge" Safety Device 20G x1 recallZ-0897-2015 · Smiths Medical ASD, Inc. · initiated Nov 21, 2014
Class II Completed All recalls posted in December 2014
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 Smiths Medical ASD, 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
Needle is not captured in the needle safety sheath in specific lots.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0897-2015
- Recall class
- Class II
- Status
- Completed
- Initiated by the company
- Nov 21, 2014
- Posted by the FDA
- Dec 30, 2014
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 334,000
- Product code
- FMI
- FDA submissions
- K041399
- 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 description
Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 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.
Code information (models, lots, serial numbers)
Lot Numbers: 2731779, 2763138, 2771516, 2771517
Other devices under the same FDA submission
2 devices cleared under K041399 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Jelco 402510Icu Medical, Inc. · Needle, hypodermic, single lumen91 reports
- Jelco 402310Icu Medical, Inc. · Needle, hypodermic, single lumen5 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 69842).
- Z-0898-2015 · CompletedHypodermic 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 intend…
- Z-0899-2015 · CompletedHypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intended…
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 18, 2026. Text above is shown as published by the FDA.
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