CLASS II ONGOING Device recall · Reported 28 Jun 2023 · FDA Enforcement Report
Draeger Softbed Resuscitaire and/or Birthing Room Warmer recalled
Draeger Medical Systems is recalling Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [, distributed nationwide in the US. The recall was initiated on 16 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1992-2023
- FDA event ID
- 92353
- Recalling firm
- Draeger Medical Systems, Telford, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 May 2023
- FDA classified
- 22 Jun 2023
- Reported
- 28 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 16 May 2023 | Recall initiated by company | |
| 22 Jun 2023 | Classified by FDA | +37 days |
| 28 Jun 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.
Product as listed by the FDA
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]
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMarylandMichiganMinnesotaMissouriMississippiMontana
Questions about this recall
Is Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [ recalled?
Yes. Draeger Medical Systems recalled Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [ on 16 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-1992-2023.
Why was it recalled?
The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.
Which lots are affected?
All units shipped from January 20, 2020 through March 1, 2023; MU20503 (Resuscitaire) UDI - 04049098000215 MU20512 (Birthing Room Warmer - BRW) UDI - 04049098058001
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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