Z-1054-2016Class II

Milex Arcing Diaphragm Size 95; Model Number: MXWS95

Name: Z-1054-2016 Milex Arcing Diaphragm Size 95; Model Number: MXWS95
Creator: CooperSurgical, Inc.
Published: 2016-02-16
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2016-02-16 / Terminated / root cause: packaging

FDA source

CooperSurgical, Inc. began a recall of Milex Arcing Diaphragm Size 95; Model Number: MXWS95 on 2016-02-16. FDA classified it as Class II and gives the reason as "The products have been identified to contain an incorrect size Diaphragm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1054-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-16
Posted: 2016-03-04
Terminated: 2016-03-29
Recalling firm: CooperSurgical, Inc.
Product: Milex Arcing Diaphragm Size 95; Model Number: MXWS95
Product code: HDW Diaphragm, Contraceptive (And Accessories)
Reason for recall: The products have been identified to contain an incorrect size Diaphragm.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Cooper Surgical sent an "Urgent - Medical Device Recall" letter dated February 16, 2016, to all affected customers. The letter identified the problem, the product and the action needed to be taken by the customer. Customers were instructed to discontinue use of the affected products and complete the attached Acknowledgement and Receipt form for replacement. For further questions, please call (203) 601-9818.
Quantity in commerce: 2 units
Distribution: US Distribution to the states of : OR and NY
Product codes and lots: Lot# 130438

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1054-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1054-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-04

Product code HDW

K063223Class IIMilex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing Diaphragms, Wideseal DiaphragmsCooperSurgical, Inc. / cleared 2008-01-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)