The Recall Desk
ModerateFDA (Devices)·Z-0931-2020·Announced 2020-02-12

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.

What this means for you

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
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

Distributed in 5 states: