NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
Summary
The FDA issued a Class II for NOA Medical Industries Behavioral Health Hospital bed side rails, Product number by NOA Medical Industries Inc. Reason: Red button used to engage side rails can break or become stuck making it difficult to engage the side rail..
Details
Source
Device Recall
External ID
Z-0838-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
Lot/Code Info: 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.
Quantity Affected: 34 units
Reason for Recall
Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.
Distribution
US: GA, MI. MA, CA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-05
Company
Washington, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NOA Medical Industries Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NOA Medical Industries Inc have FDA actions?
This is the only FDA action we have on record for NOA Medical Industries Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0838-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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