RecallRadar

FDA Device recall Z-0164-2023

MEDLINE DENTAL PACK, REF DYNJ66983

On 2022-11-09 the FDA classified a Class II recall of MEDLINE DENTAL PACK, REF DYNJ66983 by Medline Industries Northfield, citing medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0164-2023
ClassificationClass II
Statusongoing
Initiated2022-09-30
Published2022-11-09
Last updated2026-09-13 11:56 UTC
CompanyMedline Industries Northfield
DistributionUS

Product

MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.

Reason

Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

Identifiers

code_infoGTIN (01) 40193489385404, Lot Number 22DBE139

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-0164-2023%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.