Arthroscopy Procedure Tray Recalled for Excess Sterilization Residue
American Contract Systems recalls the ARTHROSCOPY WOLFSON PACK BHS Procedure tray because ethylene oxide residuals on the cast padding exceeded safety limits for permanent exposure medical devices.
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. No illnesses or injuries reported. The contaminated surgical instruments represent risk-of-harm products where injury has not yet been reported, meeting the severity rubric criteria for score 3.
Plain-English summary
American Contract Systems Inc is recalling the ARTHROSCOPY WOLFSON PACK BHS Procedure tray (Catalog Number BPAR65A) distributed nationwide in the United States. Approximately 96 units were affected.
The cast padding component of the procedure tray contains ethylene oxide and ethylene chlorohydrin (EO/ECH) residuals that exceed the approved residual limits for permanent exposure devices, as specified in ANSI/AAMI/ISO 10993-7/(R)2012 standards. These residuals are byproducts of the sterilization process.
This tray is used in arthroscopic surgical procedures. Healthcare facilities and surgical centers that received the affected lot numbers should stop using these trays immediately.
No illnesses or injuries have been reported. Users of affected lot numbers (661231, 971241, 928241, or 893241) should contact American Contract Systems Inc for instructions on returning or replacing the recalled procedure trays. The device UDI-DI is 00191072187444.
The recalled product
- Product
- ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A
- Manufacturer
- American Contract Systems Inc
- Affected units
- 96
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: 00191072187444 LOT#"s: 661231 971241 928241 893241
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
See all →- HighProcedure Tray Recalled for Excessive Ethylene Oxide Residuals
FDA (Devices) · 2024-07-17
- HighHand Procedure Kit Recalled for Excess Ethylene Oxide Residuals
FDA (Devices) · 2024-07-17
- HighArthroscopy Pack Recalled for Excessive Sterilization Chemical Residue
FDA (Devices) · 2024-07-17
- HighUpper Extremity Cast Padding Recalled for Excessive Sterilization Gas Residuals
FDA (Devices) · 2024-07-17
- HighKnee Arthroscopy Procedure Kit Recalled for Sterilization Chemical Residue
FDA (Devices) · 2024-07-17
Similar recalls
- HighSurgical Procedure Kits Recalled Due to Improper Sterilization
FDA (Devices) · 2024-02-07
- HighBreast Abdominoplasty Pack Recalled for Inadequate Sterilization Cycle Validation
FDA (Devices) · 2022-09-14
- HighGastroenterological and Urological Procedure Kits Recalled for Sterilization Process Failures
FDA (Devices) · 2024-02-07
- HighMedical Device Packs Recalled for Improper Sterilization Process
FDA (Devices) · 2023-11-01
- HighCustom OB/GYN Procedural Kits Recalled for Sterilization Process Failure
FDA (Devices) · 2024-02-07
- HighSpine Surgery Instrument Sets Recalled for Sterilization Defect
FDA (Devices) · 2022-05-18