Z-3095-2024Class II

Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and...

Name: Z-3095-2024 Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-05-07
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-05-07 / Open, Classified / root cause: packaging

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of 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 on 2024-05-07. FDA classified it as Class II and gives the reason as "Potential for an incomplete seal on the packaging tray". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3095-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-07
Posted: 2024-09-10
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Reason for recall: Potential for an incomplete seal on the packaging tray.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Medline notified consignees on about 05/06/2024 via letter sent email or First-Class mail. Consignees were instructed to examine inventory and quarantine any affected units, return any affected product that they may have on hand for credit or replacement, notify customers or personnel if the affected product was further distributed or transferred, and complete and return the response form.
Quantity in commerce: 46 units
Distribution: US Nationwide distribution.
Product codes and lots: Item Number: HARH36R. UDI/DI: 20193489081326 (case), 10193489081329 (each). Lot Numbers: 499617, 499843, 500207, 500315, 507265.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3095-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3092-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-10
Z-3093-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-10
Z-3094-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-10
Z-3095-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-10

Product code NLQ

K193563UnclassifiedMedline ReNewal Reprocessed Harmonic ACE+7 ShearsSurgical Instrument Service and Savings Inc.(Dba Medline Ren / cleared 2020-08-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)