FDA Medical Device Recalls (openFDA)
PediaLift LLC: PediaLift Access Device, Device Identifier: B751PDLFT0
- Recall number
- Z-0931-2020
- Recalling firm
- PediaLift LLC
- Product
- PediaLift Access Device, Device Identifier: B751PDLFT0
- Status
- Terminated
- Initiated
- 2019-07-03
- Posted
- not on file
- Terminated
- 2020-05-15
- Reason
- The firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the original vendor of the mattress showing that they are in compliance with labeling requirements.
- Root cause
- Nonconforming Material/Component
- Action
- Customers were contacted via email on 7/3/19. Customers were instructed to respond to the email so that replacement mattresses could be shipped. Letters dated 11/26/19 accompanied the replacement mattresses sent to customers. The letter instructed customers to please be advised that you must immediately dispose of the old mattress and utilize this replacement mattress. If you have any questions regarding this matter, feel free to contact us. Thank you, Jillena Atchison Jillena@PediaLift.com 724-417-9180
- Quantity
- 11
- Distribution
- The products were distributed to the following US states: IN, NJ, NY, OH, and PA
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMS
- Firm FEI
- 3012103974
- Firm city
- Mansfield
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28