Z-0838-2025Class II

NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

Name: Z-0838-2025 NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
Creator: NOA Medical Industries Inc
Published: 2024-11-05
License: https://open.fda.gov/license/

Noa Medical Industries / initiated 2024-11-05 / Open, Classified / root cause: design

FDA source

NOA Medical Industries Inc began a recall of NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX on 2024-11-05. FDA classified it as Class II and gives the reason as "Red button used to engage side rails can break or become stuck making it difficult to engage the side rail". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0838-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-05
Posted: 2025-01-10
Recalling firm: Noa Medical Industries
Product: NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
Product code: IKX Aid, Transfer
Reason for recall: Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.
Root cause tag: design
FDA root cause: Device Design
Action: NOA Medical Industries issued an URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION notice to its consignees on 11/05/2024 via email. The notice explained the problem with the device, potential risk, and temporary actions to employ to minimize the hazard until a replacement frame is installed. A replacement side rail will be provided. For questions or concerns, contact: [email protected] (email), https://www.noamedical.com/ (website) or 1-636-239-7600 (telephone), Monday-Friday 7:00AM to 3:30PM, CT.
Quantity in commerce: 34 units
Distribution: US: GA, MI. MA, CA
Product codes and lots: UDI/DI 00817492012745, Serial Numbers: 2038043534, 2038042756, 2038042755, 2038042750, 2038042751, 2038042752, 2038042753, 2038042754, 2038042757, 2038042244, 2038041722, 2038038738, 2038038750, 2038038749, 2038038748, 2038038747, 2038038746, 2038038745, 2038038744, 2038038758, 2038038757, 2038038756, 2038038754, 2038038753, 2038038752, 2038038755, 2038038743, 2038038742, 2038038737, 2038038751, 2038038739, 2038038740, 2038038741, 2038038766.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0838-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0838-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-10

Product code IKX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)