CLASS II Device recall · Reported 6 Oct 2021 · FDA Enforcement Report

Arjo Citadel beds originally assembled recalled

Arjohuntleigh Polska Sp. z.o.o is recalling Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, distributed nationwide in the US. The recall was initiated on 10 Jun 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesManufacturing dates 5/25/2018-2/15/2021 (printed on both the bed and IndiGo module if the module was assembled on the bed at the time of manufacture, or printed on the module if it was later installed on the bed.

Quantity recalled367 units

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-2588-2021
FDA event ID: 88469
Recalling firm: Arjohuntleigh Polska Sp. z.o.o, Komorniki, N/A
Classification: Class II
Status: Terminated
Recall initiated: 10 Jun 2021
FDA classified: 29 Sep 2021
Reported: 6 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Jun 2021	Recall initiated by company
29 Sep 2021	Classified by FDA	+111 days
6 Oct 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, burnt or short circuit with limited emission of sparks.

Product as listed by the FDA

Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (model no. INDIJAA) beds manufactured without IndiGo modules assembled at the time of manufacturing and subsequently retrofitted on the beds.

Where it was distributed

US Nationwide distribution in the states of CA, FL, IL, KY, MD, NV, NY, PA, and SD.

Nationwide California Florida Illinois Kentucky Maryland Nevada New York Pennsylvania South Dakota

Questions about this recall

Why was it recalled?

The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, burnt or short circuit with limited emission of sparks.

Which lots are affected?

Manufacturing dates 5/25/2018-2/15/2021 (printed on both the bed and IndiGo module if the module was assembled on the bed at the time of manufacture, or printed on the module if it was later installed on the bed.

Where was it sold?

US Nationwide distribution in the states of CA, FL, IL, KY, MD, NV, NY, PA, and SD.

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Arjohuntleigh Polska Sp. z.o.o

All 10

Reported	Class	Recall	Company	Reason	Where
22 Apr 2026Device	CLASS II	Arjo Tenor mobile passive patient lift recalled	Arjohuntleigh Polska Sp. z.o.o	Device Malfunction	Nationwide
3 Jan 2024Device	CLASS II	Arjo medical beds recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o	Arjohuntleigh Polska Sp. z.o.o	Other	7 states
3 Jan 2024Device	CLASS II	Arjo medical beds recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o	Arjohuntleigh Polska Sp. z.o.o	Other	7 states
1 Jun 2022Device	CLASS I	Sara Plus Active Floor Lift recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o	Arjohuntleigh Polska Sp. z.o.o	Other	Nationwide
26 Aug 2020Device	CLASS II	Bariatric Bed Frame System The Citadel Plus Bariatric Bed recalled	Arjohuntleigh Polska Sp. z.o.o	Other	Nationwide

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