FDAClass IIFebruary 8, 2023

Turbett Surgical Container recall: Sterility Concern

Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

Why was Turbett Surgical Container recalled?

Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.

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?

GTIN: 00859464007281 Lot Number: All Lot Numbers Serial Number: All Serial Numbers

Product
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Recalling firm
Turbett Surgical, Inc.
Quantity
61 units
Distribution
US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.
Recall date
February 8, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls