Medline ReNewal Harmonic ACE+7 Shears (Medline) – Packaging Seal Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
MEDLINE INDUSTRIES, LP Northfield
Lot Codes / Batch Numbers
Item Number: HARH36R. UDI/DI: 20193489081326 (case), 10193489081329 (each). Lot Numbers: 499617, 499843, 500207, 500315, 507265.
Products Sold
Item Number: HARH36R. UDI/DI: 20193489081326 (case), 10193489081329 (each). Lot Numbers: 499617, 499843, 500207, 500315, 507265.
MEDLINE INDUSTRIES, LP Northfield is recalling Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v20 due to Potential for an incomplete seal on the packaging tray.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for an incomplete seal on the packaging tray.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026