RecallRadar

FDA Device recall Z-0649-2023

DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03

On 2022-12-21 the FDA classified a Class II recall of DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03 by Deroyal Industries, citing XXX.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0649-2023
ClassificationClass II
Statusongoing
Initiated2022-11-03
Published2022-12-21
Last updated2026-09-13 11:56 UTC
CompanyDeroyal Industries
DistributionAL, AZ, CT, FL, GA, IL, IN, KS, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OH, PA, TN, TX, VA, WI

Product

DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03

Reason

XXX

Identifiers

code_info
Lot Numbers: Lot 56225516 exp 6/1/2024; Lot 56395460 exp 6/1/2024; Lot 56620751 exp 10/1/2024; Lot 56780958 exp 10/1/2…Lot Numbers: Lot 56225516 exp 6/1/2024; Lot 56395460 exp 6/1/2024; Lot 56620751 exp 10/1/2024; Lot 56780958 exp 10/1/2024; Lot 57190141 exp 10/1/2024; Lot 57754751 exp 1/1/2025

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0649-2023%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.