Z-1054-2016 Class II Terminated
FDA device recall Z-1054-2016 was initiated by CooperSurgical, Inc. on Feb 16, 2016 and is designated Class II. Reason for recall: The products have been identified to contain an incorrect size Diaphragm. The recall status is terminated (terminated Mar 29, 2016). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 16, 2016
- Initiation Date
- Feb 16, 2016
- Termination Date
- Mar 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
Milex Arcing Diaphragm Size 95; Model Number: MXWS95
Reason for Recall
The products have been identified to contain an incorrect size Diaphragm.
Distribution Pattern
US Distribution to the states of : OR and NY
Code Information
Lot# 130438
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1054-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026