RecallRadar

FDA Device recall Z-1814-2015

MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

On 2015-06-24 the FDA classified a Class II recall of MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80 by Coopersurgical, citing A diaphragm size 80 labeled box was incorrectly packaged with a size 85.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1814-2015
ClassificationClass II
Statusterminated
Initiated2015-05-20
Published2015-06-24
Last updated2026-09-13 11:53 UTC
CompanyCoopersurgical
DistributionAK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, VA, WI

Product

MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

Reason

A diaphragm size 80 labeled box was incorrectly packaged with a size 85.

Identifiers

code_infoLot 153309

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1814-2015%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.