PediaLift Access Device Recalled for Labeling Compliance Issues
PediaLift LLC is recalling 11 PediaLift Access Devices because the firm could not obtain a satisfactory Certificate of Conformance from the original vendor regarding labeling requirements.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific issue is a labeling compliance failure without reported injuries or illnesses, fitting the 'Minor labeling errors' criterion for a Moderate severity score.
Plain-English summary
PediaLift LLC is recalling 11 units of the PediaLift Access Device (Device Identifier: B751PDLFT0). The recall was initiated because the firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the original vendor of the mattress, which would show compliance with labeling requirements.
The affected products were distributed to the following US states: Indiana (IN), New Jersey (NJ), New York (NY), Ohio (OH), and Pennsylvania (PA). The specific serial numbers for the recalled units are PCL-HDPE-DL-1 through PCL-HDPE-DL-12.
Consumers who possess these devices should check their serial numbers against the list provided by the FDA. If the device is affected, they should contact PediaLift LLC for further instructions on how to proceed with the recall.
The recalled product
- Product
- PediaLift Access Device, Device Identifier: B751PDLFT0
- Manufacturer
- PediaLift LLC
- Category
- Medical Device — Access Device
- Hazard
- Affected units
- 11
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 (12)
- Serial Numbers: PCL-HDPE-DL-1
- PCL-HDPE-DL-2
- PCL-HDPE-DL-3
- PCL-HDPE-DL-4
- PCL-HDPE-DL-5
- PCL-HDPE-DL-6
- PCL-HDPE-DL-7
- PCL-HDPE-DL-8
- PCL-HDPE-DL-9
- PCL-HDPE-DL-10
- PCL-HDPE-DL-11
- PCL-HDPE-DL-12
Distribution
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