RecallRadar

FDA Device recall Z-1357-2020

Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

On 2020-03-04 the FDA classified a Class II recall of Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180 by Medline Industries, citing the sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1357-2020
ClassificationClass II
Statusterminated
Initiated2020-01-21
Published2020-03-04
Last updated2026-09-13 11:55 UTC
CompanyMedline Industries
DistributionCA

Product

Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

Reason

The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.

Identifiers

code_infoREF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1357-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.