Medline HARH45RRecalls & reported problems
Medline Industries, Inc. · HARMONIC ACE+7 SHEARS 5MM X 45CM · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489081336), received between Sep 28, 2026 and Sep 29, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K193563); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Aug 3, 2023Open, Classified
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
Z-0120-2024 · Root cause: Packaging · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937764 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923526 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K193563. One submission often covers many models, so check the product and lot details in each record.
- Z-3095-2024 · May 7, 2024 · Open, ClassifiedMedline 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.
Other Single-use reprocessed ultrasonic surgical instruments devices
- N/AStryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed1 recall94 reports
- N/AStryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed1 recall24 reports
- MEDLINE HARH36RMedline Industries, Inc. · Single-use reprocessed ultrasonic surgical instruments1 recall24 reports
- N/AStryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed67 reports
- N/AStryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed1 death31 reports
- N/A HAR1136Stryker Sustainability Solutions, Inc. · Single-use reprocessed ultrasonic surgical instruments24 reports
- Medline HAR36MRMedline Industries, Inc. · Scalpel, ultrasonic, reprocessed16 reports
- Ace + 7 HARH36RSterilmed, Inc. · Scalpel, ultrasonic, reprocessed8 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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