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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- 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
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