FDAClass IIJanuary 22, 2025

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

ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)

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?

96-2478, UDI/DI 50649111492615, Lot codes: SK-121

Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
Recalling firm
Sklar Instruments
Quantity
0 units
Distribution
Domestic: Nationwide Distribution
Recall date
January 22, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls