Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA...

FDA Device Recall #Z-1992-2023 — Class II — May 16, 2023

Recall Summary

Recall Number Z-1992-2023
Classification Class II — Moderate risk
Date Initiated May 16, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Draeger Medical Systems, Inc.
Location Telford, PA
Product Type Devices
Quantity 936 units

Product Description

Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]

Reason for Recall

The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.

Distribution Pattern

US Nationwide distribution including in the states of AL, AR, AZ, CA, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, VT, WA, and WI.

Lot / Code Information

All units shipped from January 20, 2020 through March 1, 2023; MU20503 (Resuscitaire) UDI - 04049098000215 MU20512 (Birthing Room Warmer - BRW) UDI - 04049098058001

Other Recalls from Draeger Medical Systems, Inc.

Recall # Classification Product Date
Z-1066-2025 Class II Infinity Central Station. Model Number: MS26800... Jan 14, 2025
Z-2189-2024 Class II Infinity Acute Care System (IACS) Monitoring Sy... May 13, 2024
Z-1472-2023 Class II Draeger Infinity M300 and M300+, for use with t... Apr 5, 2023
Z-1471-2023 Class II Draeger Infinity CentralStation (ICS), centrali... Apr 5, 2023
Z-1365-2022 Class II Draeger Globe-Trotter and Globe-Trotter IC, Mod... May 20, 2022

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.