Arthroscopy Pack Recalled for Excessive Sterilization Chemical Residue
American Contract Systems is recalling 345 units of the AHAR50K Standard Arthroscopy Pack due to ethylene oxide residue levels exceeding regulatory limits. Affected lot numbers are 638231, 962241, and 898241.
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 3/5 (High).
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: FDA Class II recall of a surgical device with documented chemical residue exceeding regulatory limits. This is a risk-of-harm product involving direct tissue contact, but no illnesses or injuries have been reported in the source text, placing it at the High severity tier.
Plain-English summary
American Contract Systems Inc is recalling 345 units of the AHAR50K Standard Arthroscopy Pack procedure trays distributed nationwide in the United States. The pack is used in arthroscopic surgical procedures.
The recall was issued because ethylene oxide and ethylene chlorohydrin (EO/ECH) residual levels on the cast padding component exceeded the permitted limits for permanent exposure devices as specified by the ANSI/AAMI/ISO 10993-7(R)2012 standard. Sterilization residue at levels above regulatory limits may pose a health risk to patients during arthroscopic procedures.
The affected lot numbers are 638231, 962241, and 898241, identified by UDI-DI 00191072214126. Healthcare providers and surgical facilities should verify their inventory against these lot numbers and follow appropriate recall procedures for affected units.
The recalled product
- Product
- AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50K
- Manufacturer
- American Contract Systems Inc
- Affected units
- 345
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: 00191072214126 LOT#"s: 638231 962241 898241
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 · sterilization residue
See all →- HighFoot-Ankle Procedure Tray Recalled for Excessive Sterilization Residue
FDA (Devices) · 2024-07-17
- HighMedical knee procedure kit recalled for excessive sterilization chemical residue
FDA (Devices) · 2024-07-17
- HighKnee Arthroscopy Procedure Kit Recalled for Sterilization Chemical Residue
FDA (Devices) · 2024-07-17
- HighProcedure Tray Recalled Due to Excess Sterilization Residue
FDA (Devices) · 2024-07-17
- HighKnee Scope Procedure Tray Recalled for Excess Sterilization Residue Levels
FDA (Devices) · 2024-07-17
Similar recalls
- HighSurgical Device Kits Recalled Due to Improper Sterilization Process
FDA (Devices) · 2022-05-18
- HighACS IR Angio Pack Sterilization Process Defect Recall
FDA (Devices) · 2022-05-18
- HighArthroscopy Pack Recalled Due to Unconfirmed Sterilization Assurance
FDA (Devices) · 2024-10-02
- HighACS Lap Chole Pack surgical instruments recalled for sterilization process defect
FDA (Devices) · 2022-05-18
- ModerateACS Cath Lab Packs Sterilized with Excess Ethylene Oxide
FDA (Devices) · 2022-05-18
- HighAngiography and Catheterization Packs Recalled Due to Inadequate Sterilization Validation
FDA (Devices) · 2022-09-14