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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Conmed Endoscopic Technologies, Inc.
Lot Codes / Batch Numbers
All lots manufactured from May 03, 2006 to December 14, 05 = month (May), 03 = Day of Month (3rd), 1 = Manufacturing Shift Code (1st shift).
Products Sold
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).
Conmed Endoscopic Technologies, Inc. is recalling ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 6mm (18 Fr), length due to Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026