Stryker Recalls Reprocessed Harmonic Ace Shears Due to Error Code
Stryker is recalling 180 reprocessed Harmonic Ace shears because they may display an error code preventing use.
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, but the hazard is a functional defect (error code) that prevents device use rather than a direct safety risk like injury or infection, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Sustainability Solutions is recalling 180 units of Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (Item Number HARH36, Lot number 7656512). The recall was initiated after the company received an increase in reports indicating that the affected devices may display an error code (No Instrument Uses Remaining) upon initial connection to the generator.
When this error code is present, the device is not able to be used. The affected products were distributed nationwide in the states of PA, FL, MD, MA, CA, NY, NC, TX, MT, AL, LA, and TN.
Healthcare facilities should stop using the affected devices and contact Stryker Sustainability Solutions for instructions on how to return them.
The recalled product
- Product
- Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE¿+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal therma
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 180
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)
- Lot number 7656512
Distribution
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