Smiths Medical Needle Pro Edge Safety Device Recall for Uncaptured Needles
Smiths Medical ASD, Inc. is recalling specific lots of Needle Pro Edge Safety Devices because the needle is not captured in the safety sheath.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a safety mechanism failure (needle not captured in sheath), which poses a risk of needlestick injury. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 334,000 units of the Needle Pro Edge Safety Device, 20G x1 (Reorder Number: 402010). The affected lots are 2731779, 2763138, 2771516, and 2771517. These products were distributed nationwide 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, and WV.
The recall was initiated because the needle is not captured in the needle safety sheath in specific lots. The Needle Pro Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Healthcare providers and consumers should stop using the affected lots and contact Smiths Medical ASD, Inc. for further instructions or a return.
The recalled product
- Product
- 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.
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- Affected units
- 334,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: 2731779
- 2763138
- 2771516
- 2771517
Distribution
Part of a larger recall action
This product is one of 3 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Smiths Medical ASD, Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · needlestick injury
See all →- HighMedline IV Catheter Kits Recalled Over Needle Retraction Issue
FDA (Devices) · 2025-07-09
- HighBD Insyte Autoguard IV Catheter Needles May Fail to Retract Properly
FDA (Devices) · 2023-12-06
- HighSafety Blood Collection Needles Recalled Due to Safety Mechanism Activation Difficulty
FDA (Devices) · 2021-11-17
- HighBD Nexiva IV Catheter Recall Due to Needle Shield Failure
FDA (Devices) · 2018-11-14
- SevereArrow International Recalls Hemodialysis Catheter Kits Due to Needlestick Risk
FDA (Devices) · 2017-06-14
Similar recalls
- ModerateSmith Medical JELCO Hypodermic Needle Recall for Incorrect Specifications
FDA (Devices) · 2019-06-12
- HighSmiths Medical Recalls Hypodermic Needles Due to Syringe Hub Defects
FDA (Devices) · 2017-07-12
- HighSmiths Medical Recalls Insulin Syringes With Visible Particulate on Needles
FDA (Devices) · 2014-01-15
- HighSmiths Medical Recalls Insulin Syringes Due to Visible Particulate on Needles
FDA (Devices) · 2014-01-15
- ModerateSmiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
FDA (Devices) · 2014-03-19
- HighSmiths Medical Insulin Syringes Recalled for Visible Particulate on Needles
FDA (Devices) · 2014-01-15