RegWardenFDA facility compliance records
Facility

Joerns Healthcare

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2014: 1 recalls; 2018: 1 recalls, 1 inspections1’14’15’16’172’18’19’20’21’22’23’24’25’26
  • Recalls (2)
  • Inspections (1)

Devices registered here (1)

  • Mattress, Air Flotation, Alternating Pressure
    Product code FNM (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5550

Recalls & enforcement

  • Class IITerminated2018-05-03
    Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the …
  • Class IITerminated2014-09-24
    The Easy-Care Care-Lock feature installed at the foot of the bed may potentially fail to stay engaged (locked) after the Care-Lock System has been engaged by stepping on the red (locked) pedal.

FDA inspections (1)

  • NAI2018-08-02
    No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

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

Cite this record

RegWarden. “Joerns Healthcare (FEI 3009402404) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009402404-joerns-healthcare/

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