Harmonic ACE Curved Shear Recall Due to Compromised Sterile Seal
Surgical Instrument Service And Savings, Inc. is recalling Harmonic ACE Curved Shears because the sterile seal may be compromised, allowing the product to fall out of the pouch.
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. The hazard involves a compromised sterile barrier, which is a significant quality issue but does not meet the criteria for Severe (Class I or reported hospitalization) or High (high-risk pathogens or specific injury risks). It is not a cosmetic or documentation-only issue, placing it at Moderate.
Plain-English summary
Surgical Instrument Service And Savings, Inc. is recalling Harmonic ACE Ergonomically-Enhanced Curved Shears, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm, Reference ACE36E. The affected lots are 122295, 122308, and 122762. A total of 3 units were distributed nationwide.
The recall was initiated because the seal that maintains a sterile barrier for these reprocessed medical devices became compromised. This defect may allow the product to fall out of the pouch, potentially compromising sterility.
Healthcare facilities and consumers who possess these specific lots should stop using the product and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 Unclassified
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Affected units
- 3
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 (3)
- 122295
- 122308
- 122762.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Surgical Instrument Service And Savings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 22 products in this recall →Related recalls
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