Sterile surgical convenience kits: 1 — Class II medical device recall Z-1438-2023
Ongoing recall by ROi CPS LLC, reported 2023-05-03, distributed nationwide. The recalling firm was notified by their supplier that the light handle covers may separate from the light han
| Recall number | Z-1438-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2023-03-22 |
| Classified | 2023-04-25 |
| Reported by FDA | 2023-05-03 |
| Distributed | Nationwide (US) |
| Quantity | 1,369 kits |
| UPC / GTIN / UDI-DI | 10194717111016, 10194717112150, 10194717112341, 10194717112365, 10194717112778, 10194717113713, 10194717113904, 10194717114154, 10194717114161, 10194717114178, 10194717114185, 10194717114192 |
| Lot numbers | 95080, 95310, 95381, 95388, 95422, 95503, 95516, 95555, 95633, 95634, 95667, 95769 |
| Model numbers | 800755006, 800772006, 880403004, 880426004, 880427003, 880468001, 880470001, 880471001, 880472001, 880473001, 880474001, 880480001, OR00960FOH, OR00977FOH, OR01009D, OR01033D, OR01034C, OR01100A, OR01102A, OR01103A, OR01104A, OR01105A, OR01106A, OR01112A |
| Expiration dates | 2023-12-31, 2024-05-30, 2024-09-07, 2024-09-30, 2024-10-17, 2024-10-27, 2024-10-29, 2024-11-29, 2024-11-30 |
Product
Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthroscopy; 5. regard Item Number: 800772006, OR00977F - OH Total Knee Pack ; 6. regard Item Number: 880403004, OR01009D - Extremity Pack; 7. regard Item Number: 880472001, OR01104A - Basic Pack ; 8. regard Item Number: 880470001, OR01102A - Total Knee ; 9. regard Item Number: 800755006, OR00960F - OH Hip Pack ; 10. regard Item Number: 880471001, OR01103A - Shoulder Arthroscopy ; 11. regard Item Number: 880480001, OR01112A - Hand and Foot ; and 12. regard Item Number: 880468001, OR01100A - Spine.
Reason for recall
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1438-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.