FDA Medical Device Recalls (openFDA)
Cook OB/Gyn, Inc.: Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL. Used to obtain endometrial samples for both cytology and histology. Intended for one-time use.
- Recall number
- Z-1416-2009
- Recalling firm
- Cook OB/Gyn, Inc.
- Product
- Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL. Used to obtain endometrial samples for both cytology and histology. Intended for one-time use.
- Status
- Terminated
- Initiated
- 2009-04-02
- Posted
- 2009-06-16
- Terminated
- 2009-12-03
- Reason
- There is an ink on the brush which has not been tested for use with the Tao Brush.
- Root cause
- Process control
- Action
- The consignee was notified by an Urgent: Recall Notice letter dated 4/2/09. The customer is to forward the notice to all personnel that need to be aware of it; pull from their stock and isolate any affected product; and complete the form. Upon receipt of the form, Cook Women's Health will issue a Return Goods Authorization number and the customer should return the affected products via FedEx using the Return Goods Authorization number.
- Quantity
- 15,396
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lots UF1793872 through UF1793877, UF1811910 through UF1811913, UF1811916, UF1811917, UF1811917S, UF1811918, UF1811919, UF1816687 and UF1816688.
- 510(k) numbers
- ["K082066","K941298"]
- PMA numbers
- not on file
- Product code
- HFE
- Firm FEI
- not on file
- Firm city
- Spencer
- Firm state
- IN
- 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