FDA Medical Device Recalls (openFDA)
Conmed Endoscopic Technologies, Inc.: ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 6mm (18 Fr), length 4cm; product code/end item #000844; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
- Recall number
- Z-0943-2007
- Recalling firm
- Conmed Endoscopic Technologies, Inc.
- Product
- ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 6mm (18 Fr), length 4cm; product code/end item #000844; Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
- Status
- Terminated
- Initiated
- 2007-04-16
- Posted
- 2007-06-19
- Terminated
- 2010-07-30
- Reason
- Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
- Root cause
- Other
- Action
- Notification Letters were sent to domestic consignees on 04/16/07 and to international consignees on 04/17/07. Consignees instructed to discontinue product use, sub recall to accounts sold product, and to contact Stericycle, Inc. at 1-800-668-4391 for instructions on returning product.
- Quantity
- 63 units.
- Distribution
- Worldwide-Devices distributed to medical facilities and distributors Nationwide (USA) and to distributors in the following countries: Australia, Belgium, Canada, Croatia, Denmark, Germany, India, Italy, Japan, Mexico, Poland, Spain and Sweden.
- Lot, serial or model codes
- All lots manufactured from May 03, 2006 to December 14, 2006 which includes lot numbers/codes from 0605031 to 0612141. Lot code identification is as follows: For lot #0605031: 06 = year (2006); 05 = month (May); 03 = Day of Month (3rd); 1 = Manufacturing Shift Code (1st shift).
- 510(k) numbers
- ["K033936"]
- PMA numbers
- not on file
- Product code
- KNQ
- Firm FEI
- 1000159712
- Firm city
- Billerica
- Firm state
- MA
- 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