MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis… recallZ-0120-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Aug 3, 2023
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
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
FDA root cause category: Packaging
What the company is doing
Medline issued a recall notice to its consignees by email on 08/03/2023. The notice explained the problem and the potential risk. Those consignees who have transferred possession of the affected product were directed to notify their customers. The firm is seeking the return of the affected product. An error in the model number was noted (missing an "R" at the end) and the firm issued an updated letter on 09/19/2023 with the corrected number.
Recall details
- Recall number
- Z-0120-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 3, 2023
- Posted by the FDA
- Oct 16, 2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 18 units
- Product code
- NLQ
- FDA submissions
- K193563
- Distribution
- US
Product description
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
Code information (models, lots, serial numbers)
UDI/DI 10193489081336 (each), 20193489081333 (case), Lot Numbers: 498739, 498740, 499057, 499143, 499227
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline HARH45RMedline Industries, Inc. · Single-use reprocessed ultrasonic surgical instruments1 recall2 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 HARH36RMedline Industries, Inc. · Single-use reprocessed ultrasonic surgical instruments1 recall24 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92920).
- Z-0117-2024 · Open, ClassifiedMEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosurgical instrument
- Z-0118-2024 · Open, ClassifiedMEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument
- Z-0119-2024 · Open, ClassifiedMEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument
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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