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NOA Medical Industries Behavioral Health Hospital bed side… recallZ-0838-2025 · NOA Medical Industries Inc · initiated Nov 5, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from NOA Medical Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0838-2025
Status
Open, Classified
Initiated by the company
Nov 5, 2024
Posted by the FDA
Jan 10, 2025
Recalling firm
NOA Medical Industries Inc
Quantity
34 units
Product code
IKX
Distribution
US: GA, MI. MA, CA

Product description

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

Code information (models, lots, serial numbers)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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