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.
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 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.
See all 22 products in this recall →Related recalls
Same manufacturer · Surgical Instrument Service And Savings, Inc.
See all →- ModerateSurgical Instrument Service And Savings Recalls Phacofragmentation System Tips
FDA (Devices) · 2013-07-10
- ModerateHarmonic ACE Curved Shear Recall Due to Compromised Sterile Seal
FDA (Devices) · 2013-07-10
- ModerateSurgical Instrument Service And Savings Recalls 15 Suture Instruments
FDA (Devices) · 2013-07-10
- ModerateSurgical Instrument Service And Savings Recalls Relieva Flex Sinus Guide Catheter
FDA (Devices) · 2013-07-10
- ModerateSurgical Instrument Service And Savings Recalls Arthroscopic Cannulas Due to Seal Defect
FDA (Devices) · 2013-07-10
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighMicroline Surgical Recalls ReNew Endocut Scissor Tips Due to Sterility Concerns
FDA (Devices) · 2018-05-16
- HighEthicon Recalls Endopath Electrosurgery Probes Due to Potential Sterility Compromise
FDA (Devices) · 2013-07-31
- HighMedline Surgical Scissors Recalled for Sterility Seal Defect
FDA (Devices) · 2025-01-01
- HighMedline Centurion surgical scissors recalled due to weak seals
FDA (Devices) · 2024-04-10
- HighMedline Iris Scissors Recalled Due to Detachable Tip Protector Risk
FDA (Devices) · 2023-09-27
- HighIntuitive Surgical Recalls 8MM Surgical Scissors for Grip Cable Defects
FDA (Devices) · 2025-01-22