Emergency relief bed recalled for missing UDI and incorrect weight limit label
Oakworks Inc is recalling PX200 Emergency Relief Beds due to labeling defects. The product label is missing the UDI number and states an incorrect weight capacity of 500 lbs instead of the actual 400 lb limit.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II labeling defect involving incorrect weight capacity specification (500 lbs on label vs. actual 400 lbs limit). No reported injuries, placing this in the risk-of-harm category per the severity rubric.
Plain-English summary
Oakworks Inc is recalling 130 PX200 Emergency Relief Beds, Model No. PXEXEB362280A6TTZZH4C19, due to labeling defects on this FDA Class II medical device.
The product label was printed without the UDI (Unique Device Identifier) number. Additionally, the weight capacity specified on the label is incorrect, showing a limit of 500 lbs when the actual maximum weight capacity is 400 lbs.
The affected devices were distributed in Massachusetts, New Jersey, and Pennsylvania. Serial numbers affected range from PXR769629 to PXR769829.
Consult with Oakworks Inc or the FDA for information regarding recall remedies and next steps for units in your possession.
The recalled product
- Product
- PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19
- Manufacturer
- Oakworks Inc
- Affected units
- 130
Distribution
Part of a larger recall action
This product is one of 2 recalled by Oakworks Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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