Sterile surgical C-section kit light handle covers recalled for separation risk
ROi CPS LLC recalls sterile surgical C-section kits due to light handle covers that may separate and fall during use. The recall affects 1,312 kits distributed in Florida and Missouri.
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 is a risk-of-harm product where injury has not yet been reported, per the rubric for Score 3. The light handle cover separation poses a potential hazard during a critical surgical procedure, though no actual incidents or illnesses have been documented.
Plain-English summary
ROi CPS LLC is recalling 1,312 sterile surgical convenience kits (Item Number 800706005, LD0091E - OH C-Section Pack) distributed in Florida and Missouri. The affected lots are #95165 (expiration 10/27/2024), #95374 (expiration 10/17/2024), and #95615 (expiration 11/15/2024).
The light handle covers in these kits may separate from the light handle and fall off during surgical use. The defect was identified when the manufacturer was notified by their supplier of this potential separation issue.
Healthcare facilities with these kits should verify lot numbers against their inventory. The FDA and the manufacturer should be contacted with questions or if separated components are discovered during kit use.
The recalled product
- Product
- Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Surgical Kit
- Hazard
- component-separation
- surgical-kit-defect
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 (9)
- Lot #95165
- exp. 10/27/2024
- UDI (01)10194717116387(17)241027(10)95165
- lot #95374
- exp. 10/17/2024
- UDI (01)10194717116387(17)241017(10)95374
- and lot #95615
- exp. 11/15/2024
- UDI (01)10194717116387(17)241115(10)95615.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03