ECONO STERILE Orthopedic Probes Recalled for Sterile Barrier Breach Risk
Sklar Instruments recalls 2,500 ECONO STERILE orthopedic probe kits due to packaging issues that may breach the sterile barrier. No illnesses or injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves a potential sterile barrier breach on surgical instruments. Although no illnesses or injuries have been reported, the sterile compromise risk on devices intended for surgical use represents a high-risk concern.
Plain-English summary
Sklar Instruments is recalling 2,500 ECONO STERILE medical procedure kits sold nationwide. The recalled products are orthopedic probes in two models: 94-5923 (50-unit cartons) and 96-2361 (25-unit cartons).
The recall was issued due to reports of packaging issues that may result in a breach of the sterile barrier in these medical devices. The affected lot codes are SK-115 and SK-116 for Model 94-5923, and SK-115 for Model 96-2361.
Customers who have received these products should discontinue use and contact Sklar Instruments regarding replacement or return. No illnesses or injuries have been reported in connection with this issue.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe
- Manufacturer
- Sklar Instruments
- Affected units
- 2,500
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 (7)
- 1) 94-5923
- UDI/DI 50649111181663
- Lot codes: SK-115
- SK-116
- 2) 96-2361
- UDI/DI 50649111392601
- Lot codes: SK-115.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Sklar Instruments 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 30 products in this recall →Related recalls
Same manufacturer · Sklar Instruments
See all →- HighSklar Instruments iris hooks recalled for sterile packaging integrity issues
FDA (Devices) · 2025-01-22
- HighECONO STERILE Procedure Kits Recalled for Sterile Barrier Breach Risk
FDA (Devices) · 2025-01-22
- HighSklar Instruments IUD Extractor Kits Recalled for Sterile Barrier Packaging Issues
FDA (Devices) · 2025-01-22
- HighSklar Instruments Sterile Surgical Kits Recalled for Packaging Defects
FDA (Devices) · 2025-01-22
- HighECONO STERILE Gynecologic Biopsy Kits Recalled for Sterile Packaging Issues
FDA (Devices) · 2025-01-22
Same hazard · sterile barrier breach
See all →- ModerateBoston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk
FDA (Devices) · 2026-08-12
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
- ModeratePhantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches
FDA (Devices) · 2026-07-29
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27