FDAClass IIApril 7, 2021

Stryker Sustainability Solutions recall

Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product…

Why was Stryker Sustainability Solutions recalled?

Product was distributed without receiving regulatory clearance.

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?

Catalog Number: HARH36 GTIN: 07613327346251 Lot Number: 12444050

Product
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product…
Recalling firm
Stryker Sustainability Solutions
Quantity
102 units
Distribution
Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.
Recall date
April 7, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls