Sklar Instruments Recalls ECONO STERILE Surgical Scalpel Handles for Sterile Barrier Risk
Sklar Instruments recalls ECONO STERILE SCALPEL HDL #3 surgical handles due to packaging issues that may compromise the sterile barrier. The 150-unit recall affects units distributed nationwide with lot code SK-125.
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: This is an FDA Class II recall involving a risk-of-harm medical device (surgical instrument with potentially compromised sterile barrier) where no illnesses or injuries have been reported. Per the severity rubric, this fits the High (3) category: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE SCALPEL HDL #3 surgical handles (Model 96-3500M, UDI/DI 50649111149960) due to reports of packaging issues that may result in a breach of the sterile barrier.
The recall affects 150 units with lot code SK-125 distributed nationwide. Affected units are identified by model number 96-3500M and UDI/DI 50649111149960.
A breach of the sterile barrier in medical devices used in surgical procedures could result in the product becoming contaminated or non-sterile. This may compromise patient safety if the affected products are used in medical procedures.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
- Manufacturer
- Sklar Instruments
- Affected units
- 150
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 (3)
- 96-3500M
- UDI/DI 50649111149960
- Lot codes: SK-125
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Sklar Instruments 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.
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