Knee Surgery Procedure Kit Recalled for Ethylene Oxide Residue
American Contract Systems Inc recalled a knee surgery procedure kit (Catalog RGTK10K) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits on the cast padding component.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is chemical residuals exceeding established safety standards, constituting a precautionary compliance issue rather than documented harm.
Plain-English summary
American Contract Systems Inc is recalling the TOTAL KNEE 297835-Procedure Kit (Catalog Number RGTK10K) distributed nationwide. The recall affects 24 units with Lot 665231.
The cast padding component of the procedure kit contained ethylene oxide and ethylene chlorohydrin residuals that exceeded the safety limits specified in the ANSI/AAMI/ISO 10993-7/(R)2012 standard for permanent-exposure medical devices.
Healthcare facilities and providers should stop using these kits immediately and contact American Contract Systems Inc for return or replacement instructions. Facilities should identify any patients who received procedures using the affected units.
The recalled product
- Product
- TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K
- Manufacturer
- American Contract Systems Inc
- Hazard
- Affected units
- 24
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 (1)
- UDI-DI: 00191072203267 LOT#"s: 665231
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 recalled by American Contract Systems 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 39 products in this recall →Related recalls
Same manufacturer · American Contract Systems Inc
See all →- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
Same hazard · ethylene oxide residue
See all →- HighKnee Arthroscopy Kit Recalled for Excessive Sterilant Chemical Residue
FDA (Devices) · 2024-07-17
- HighProcedure Tray Recalled for Excess Ethylene Oxide Residue
FDA (Devices) · 2024-07-17
- HighKnee Arthroscopy Kit Recalled for Elevated Sterilization Chemical Residues
FDA (Devices) · 2024-07-17
- HighTotal Knee Procedure Kit Recalled for Excess Ethylene Oxide Residue
FDA (Devices) · 2024-07-17
- HighProcedure Kit Recalled for Excess Ethylene Oxide Residue in Cast Padding
FDA (Devices) · 2024-07-17
Similar recalls
- HighMedical Device Convenience Kits Recalled for Ethylene Oxide Residual Contamination
FDA (Devices) · 2025-06-18
- HighSurgical Device Kits Recalled Due to Improper Sterilization Process
FDA (Devices) · 2022-05-18
- HighMedical Device Packs Recalled for Improper Sterilization Process
FDA (Devices) · 2023-11-01
- HighZimmer Biomet Recalls Polyethylene Knee Implants Due to Endotoxin Levels
FDA (Devices) · 2017-04-26
- HighBiomet Oxford Partial Knee Systems Recalled for Elevated Endotoxin Levels
FDA (Devices) · 2020-06-03
- HighCranial Surgery Procedure Kit Recalled Over Sterility Assurance Failure
FDA (Devices) · 2025-03-26