Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B Recalled by American Contract Systems Inc Due to Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast...

Date: May 15, 2024
Company: American Contract Systems Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact American Contract Systems Inc directly.

Affected Products

ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B

Quantity: 84 units

Why Was This Recalled?

Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About American Contract Systems Inc

American Contract Systems Inc has 81 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report