Regard Shoulder surgical kits recalled due to defective included drapes
ROi CPS LLC is recalling Regard SHOULDER surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled. Affected kits were distributed to healthcare facilities in LA, MO, NC, and FL.
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: Class II FDA recall involving surgical medical devices. Surgical kits are inherent risk-of-harm products; although no patient injuries or illnesses have been reported, distributed kits present potential harm risk in clinical use.
Plain-English summary
Regard SHOULDER surgical convenience kits (Model GS00828G, Item Number 880367007) manufactured by ROi CPS LLC are being recalled. These surgical kits contain 3M surgical drapes that were found to be subject to a separate recall. Approximately 28 kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida. The affected product includes Lot Number 91778 with an expiration date of March 8, 2024, and has a UDI/DI of 10194717105121.
Healthcare facilities that have received these kits should immediately stop using them and contact ROi CPS LLC for instructions on return or disposal of the affected units.
Patients who underwent surgical procedures using these kits should contact their healthcare provider if they have concerns or experience complications potentially related to their surgical care.
The recalled product
- Product
- regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Surgical Kits
- Hazard
- surgical-drape-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 (3)
- UDI/DI 10194717105121
- Lot Numbers: 91778
- exp 3/8/2024
Distribution
Distributed in 4 states:
- FL
- LA
- MO
- NC
Related recalls
Same category
- HighSurgify Halo surgical drill recalled for potential burr breakage
FDA (Devices) · 2026-07-01
- SevereMedline convenience kits recalled for unapproved syringe design changes
FDA (Devices) · 2026-07-01
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- SevereMedline Convenience Kits with Lidocaine and Bupivacaine Injections Recalled
FDA (Devices) · 2026-07-01