Stryker Harmonic ACE +7 Shears Recalled for Lack of Regulatory Clearance
Stryker is recalling 102 units of Harmonic ACE +7 Shears because they were distributed without receiving regulatory clearance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stryker Sustainability Solutions is recalling 102 units of the Ethicon Endo-Surgery, Inc. Harmonic ACE +7 Shears with Advanced Hemostasis (5mm Diameter x 36cm). The product is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
The recall was initiated because the product was distributed without receiving regulatory clearance. The affected units are identified by Catalog Number HARH36, GTIN 07613327346251, and Lot Number 12444050.
The product was distributed worldwide, including nationwide distribution in the United States (specifically Ohio) and in Israel. No specific instructions for consumers are provided in the source text.
The recalled product
- Product
- Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be us
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 102
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: HARH36 GTIN: 07613327346251 Lot Number: 12444050
Distribution
Related recalls
Same manufacturer · Stryker Sustainability Solutions
See all →- HighDaig Livewire Steerable Electrophysiology Catheter Sterile Seal Defect Recall
FDA (Devices) · 2026-05-20
- HighReprocessed electrophysiology catheters recalled over incomplete sterile seals
FDA (Devices) · 2026-05-20
- HighReprocessed Electrophysiology Catheter Recalled for Incomplete Seals
FDA (Devices) · 2026-05-20
- HighDaig Livewire Steerable Electrophysiology Catheters Recalled for Incomplete Seals
FDA (Devices) · 2026-05-20
- HighReprocessed Electrophysiology Catheter Recalled for Incomplete Sterile Seals
FDA (Devices) · 2026-05-20
Same hazard · regulatory non compliance
See all →- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01