Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears… recallZ-3095-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated May 7, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for an incomplete seal on the packaging tray.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-3095-2024
- Status
- Open, Classified
- Initiated by the company
- May 7, 2024
- Posted by the FDA
- Sep 10, 2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 46 units
- Product code
- NLQ
- FDA submissions
- K193563
- Distribution
- US Nationwide distribution.
Product description
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.
Code information (models, lots, serial numbers)
Item Number: HARH36R. UDI/DI: 20193489081326 (case), 10193489081329 (each). Lot Numbers: 499617, 499843, 500207, 500315, 507265.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MEDLINE HARH36RMedline Industries, Inc. · Single-use reprocessed ultrasonic surgical instruments1 recall24 reports
Other devices under the same FDA submission
1 device cleared under K193563 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Medline HARH45RMedline Industries, Inc. · Single-use reprocessed ultrasonic surgical instruments1 recall2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95126).
- Z-3092-2024 · Open, ClassifiedMedline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.
- Z-3093-2024 · Open, ClassifiedMedline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.
- Z-3094-2024 · Open, ClassifiedMedline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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