ECONO STERILE Trousseau Dilator (Sklar) – Packaging Sterility Breach (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
Brand
Sklar Instruments
Lot Codes / Batch Numbers
941-0191, UDI/DI 50649111232730. Lot codes: 9249410191
Products Sold
941-0191, UDI/DI 50649111232730. Lot codes: 9249410191
Sklar Instruments is recalling ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Numb due to Reports of various packaging issues that may result in a breach of the sterile barrier.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reports of various packaging issues that may result in a breach of the sterile barrier.
Recommended Action
Per FDA guidance
On December 3, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Action required: 1. Check your inventory for any affected product lots (see Attachment A). If you have affected product in inventory, discontinue use immediately. 2. Notify Additional Users. If you have further distributed any of the items referenced in this notification, you must notify those downstream customers of this recall. Forward a copy of this letter, along with copies of Attachment A and the Recall Acknowledgement form, for such customers to complete and return to Sklar. 3. Notify Sklar. Please complete the enclosed Recall Acknowledgement form as soon as possible, indicating whether you do or do not have any of the affected products remaining in your inventory and whether you have distributed any of the affected products to downstream customers. Return the form to Sklar by e-mail to surgi@sklarcorp.com. 4. Return the affected product. If you do have any of the affected products in inventory, Sklar customer service will contact you to arrange for the affected product to be returned. Sklar will credit its direct customers for returned affected product once it receives the affected product back. Sklar Instruments is committed to providing high quality, safe, and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have experienced an adverse event associated with any of these products, please contact us and/or report the event to FDA s MedWatch Adverse Event Reporting program online.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026