Z-1824-2015Class II

McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to...

Name: Z-1824-2015 McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to...
Creator: CooperSurgical, Inc.
Published: 2015-04-13
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2015-04-13 / Terminated / root cause: packaging

FDA source

CooperSurgical, Inc. began a recall of McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and... on 2015-04-13. FDA classified it as Class II and gives the reason as "Small sized specula were incorrectly packaged in printed bags for the medium sized speculum". 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-1824-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-13
Posted: 2015-06-22
Terminated: 2016-02-05
Recalling firm: CooperSurgical, Inc.
Product: McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures
Product code: HIB Speculum, Vaginal, Nonmetal
Reason for recall: Small sized specula were incorrectly packaged in printed bags for the medium sized speculum
Root cause tag: packaging
FDA root cause: Packaging change control
Action: CooperSurgical sent an Urget Medical Device Recall letter dated April 13, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to discontinue use, discard, or return the affected to product to Cooper Surgical. Customers were asked to complete the attached Acknowledgment and Receipt Form for replacement. Customers with questions were instructed to call 203-601-5200.
Quantity in commerce: 9400 units
Distribution: Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.
Product codes and lots: Work Order:164290

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1824-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1824-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-22

Product code HIB

K841909Class IIVaginal Speculum - DisposableGalenica Enterprises, Inc. / cleared 1984-07-31

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)