NOA Medical Industries Hospital Bed Side Rails Recalled for Defective Engagement Button
NOA Medical Industries is recalling 34 hospital bed side rails (Model 1055050GRY-BOX) because the red button used to engage the rails can break or become stuck, making it difficult to engage the safety rails.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a mechanical defect that impairs the function of critical safety equipment. Although no injuries or hospitalizations have been reported, the defect involves a safety-mechanism failure in equipment designed to protect vulnerable hospitalized patients, fitting the criterion for High severity.
Plain-English summary
NOA Medical Industries Inc is recalling 34 units of Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX. The affected units are distributed in Georgia, Michigan, Massachusetts, and California, and are identified by UDI/DI 00817492012745.
The red button used to engage the side rails can break or become stuck, making it difficult to engage the rails. These side rails are critical safety equipment designed to protect patients in hospital behavioral health units, so this mechanical defect creates a significant patient safety risk.
Healthcare facilities should verify whether they have received any of these recalled side rails by checking the provided serial numbers and contact NOA Medical Industries Inc for instructions on replacement or repair.
The recalled product
- Product
- NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
- Manufacturer
- NOA Medical Industries Inc
- Hazard
- mechanical-defect
- safety-mechanism-failure
- patient-safety-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 00817492012745
- Serial Numbers: 2038043534
- 2038042756
- 2038042755
- 2038042750
- 2038042751
- 2038042752
- 2038042753
- 2038042754
- 2038042757
- 2038042244
- 2038041722
- 2038038738
- 2038038750
- 2038038749
- 2038038748
- 2038038747
- 2038038746
- 2038038745
- 2038038744
Distribution
Distributed in 4 states:
- CA
- GA
- MA
- MI
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