Surgical Instrument Service And Savings Recalls Scorpion Needles Due to Seal Compromise
Surgical Instrument Service And Savings, Inc. is recalling specific lots of Scorpion Needles and Suture Passing Wires because the sterile barrier seal may be compromised, allowing 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential loss of sterility due to a packaging seal defect, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Surgical Instrument Service And Savings, Inc. is recalling specific lots of Scorpion Needles and Suture Passing Wires. The affected products include the Scorpion Needle (Blue, Ref. AR-13990N, Lot 123263), SureFire Scorpion Needle (Purple, Ref. AR-13991N, Lots 123263 and 122279), and Suture Passing Wire (Ref. AR-1255-18, Lot 123190). These are manual surgical instruments for general use.
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. The agency classified this as a Class II recall.
The products were distributed nationwide. A total of 6 units are involved in this recall. Users should check their inventory for the specific reference numbers and lot numbers listed above and stop using the affected items.
The recalled product
- Product
- -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Affected units
- 6
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)
- 123263
- 122279
- 123190.
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
- HighMedline Centurion surgical scissors recalled due to weak seals
FDA (Devices) · 2024-04-10
- HighSmith & Nephew Recalls Raptormite Suture Anchors Due to Seal Defects
FDA (Devices) · 2020-10-28
- HighSurgilon Braided Nylon sutures recalled due to sterile barrier defect
FDA (Devices) · 2023-03-08
- HighCenturion Manual surgical kits recalled due to weak seals risking sterility breach
FDA (Devices) · 2024-04-10
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighArrow International Recalls Spring Wire Guide Introducer Needles Due to Packaging Defect
FDA (Devices) · 2018-06-06