RegWardenFDA facility compliance records
Recall

Class II — Getinge (Suzhou) Co Ltd

Recalling firmGetinge
Registered facilityGetinge Group Logistics America, LLC (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonThere is a potential for abnormal inflation of the mattress.
ProductNimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
Quantity13042 units
DistributionUSA
Initiated2021-04-15
Classified2021-06-03
Terminated2023-11-13
Recall numberZ-1788-2021
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Getinge (Suzhou) Co Ltd (Z-1788-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87752/

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