Data Foundry

Medical device recalls 2023

Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale… — Class II medical device recall Z-1992-2023

Ongoing recall by Draeger Medical Systems, Inc., reported 2023-06-28, distributed nationwide. The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.

Recall numberZ-1992-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmDraeger Medical Systems, Inc., Telford, PA, United States
Recall initiated2023-05-16
Classified2023-06-22
Reported by FDA2023-06-28
DistributedNationwide (US)
Quantity936 units
UPC / GTIN / UDI-DI04049098000215, 04049098058001
Model numbersRW82-1, RW82-1C, RW82-1D, RW82VHA-1, RW82VHA-1C, RW82VHA-1D, WBR82-1

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1992-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.