FDAClass IIJanuary 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO recall: Sterility Concern

ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor

Why was ECONO STERILE medical procedure kits labeled as: ECONO recalled?

Reports of various packaging issues that may result in a breach of the sterile barrier.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

96-2395M, UDI/DI 50649111448896, Lot codes: SK-133

Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor
Recalling firm
Sklar Instruments
Quantity
25 units
Distribution
Domestic: Nationwide Distribution
Recall date
January 22, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls