Surgical Instrument Service Recalls Re-New II Endocut Scissor Tips
Surgical Instrument Service and Savings, Inc. is recalling 10 Re-New II Endocut Scissor Tips because the sterile barrier seal is compromised, allowing the product to fall out of the pouch.
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 involves a compromised sterile barrier for a medical device, which is a significant quality issue but does not meet the criteria for Severe (Class II with hospitalization) or High (high-risk pathogens). It is classified as Moderate due to the potential for loss of sterility without reported injuries.
Plain-English summary
Surgical Instrument Service and Savings, Inc. is recalling 10 units of the Re-New II Endocut Scissor Tip, 16.51mm 5.0mm, Reference 3142. The affected lots are 122295, 122308, 122455, and 122875. These are manual surgical instruments intended for general use.
The recall was initiated because the seal that maintains a sterile barrier for these reprocessed medical devices became compromised. This defect allows the product to fall out of the pouch, potentially compromising sterility.
The products were distributed nationwide. Consumers and healthcare facilities should stop using the affected items and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 Manual surgical instrument for general use.
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Hazard
- Affected units
- 10
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 (4)
- 122295
- 122308
- 122455
- 122875.
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.
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