FDAClass IISeptember 18, 2024

Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 recall

Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.

Why was Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 recalled?

Potential for an incomplete seal on the packaging tray.

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?

Item Number: HARH36R. UDI/DI: 20193489081326 (case), 10193489081329 (each). Lot Numbers: 499617, 499843, 500207, 500315, 507265.

Product
Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
46 units
Distribution
US Nationwide distribution.
Recall date
September 18, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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