FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: 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
- Recall number
- Z-1824-2015
- 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
- Status
- Terminated
- Initiated
- 2015-04-13
- Posted
- 2015-06-22
- Terminated
- 2016-02-05
- Reason
- Small sized specula were incorrectly packaged in printed bags for the medium sized speculum
- 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
- 9400 units
- Distribution
- Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.
- Lot, serial or model codes
- Work Order:164290
- 510(k) numbers
- ["K841909"]
- PMA numbers
- not on file
- Product code
- HIB
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28