Z-1814-2015 Class II Terminated
FDA device recall Z-1814-2015 was initiated by CooperSurgical, Inc. on May 20, 2015 and is designated Class II. Reason for recall: A diaphragm size 80 labeled box was incorrectly packaged with a size 85. The recall status is terminated (terminated Jan 20, 2016). Affected quantity: 200 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 24, 2015
- Initiation Date
- May 20, 2015
- Termination Date
- Jan 20, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 units
Product Description
MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
Reason for Recall
A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
Distribution Pattern
AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND
Code Information
Lot 153309
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1814-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026