remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clin...

FDA Device Recall #Z-2531-2023 — Class II — August 14, 2023

Recall Summary

Recall Number Z-2531-2023
Classification Class II — Moderate risk
Date Initiated August 14, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Remel, Inc
Location Lenexa, KS
Product Type Devices
Quantity 139 units (13,900 tests)

Product Description

remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora

Reason for Recall

On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024

Other Recalls from Remel, Inc

Recall # Classification Product Date
Z-1474-2026 Class II Campy CVA Medium 100/PK, R01272 Feb 5, 2026
Z-0585-2026 Class II 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 ... Nov 12, 2025
Z-2226-2025 Class II Blood/MacConkey Biplate 100/PK, Product Number ... Jul 11, 2025
Z-2224-2025 Class II Strep Selective II Agar, Product Number R01859 Jul 11, 2025
Z-2225-2025 Class II Blood/EMB, Levine 100/PK, Product Number R02041 Jul 11, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.