Conmed Corporation POOLE Suction Instrument, REF 0035040. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
POOLE Suction Instrument, REF 0035040. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
Brand
Conmed Corporation
Lot Codes / Batch Numbers
REF 0035040, lot 0409271: the first 2 digits represent the year manufactured (04 represents 2004), next 2 digits represent the month (09 represents September), the next 2 digits represent the day of the month (27), and the last digit represents the manufacturing shift code (1).
Products Sold
REF 0035040; All lots manufactured between 10/04/2001 and 10/04/2006. Lot codes on boxes and packaging contain a 7 digit lot code: For example, lot 0409271: the first 2 digits represent the year manufactured (04 represents 2004), next 2 digits represent the month (09 represents September), the next 2 digits represent the day of the month (27), and the last digit represents the manufacturing shift code (1).
Conmed Corporation is recalling POOLE Suction Instrument, REF 0035040. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica due to Firm was made aware of instances where the sterile barrier of the instruments had been compromised.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Firm was made aware of instances where the sterile barrier of the instruments had been compromised.
Recommended Action
Per FDA guidance
On 11/10/06, ConMed Corp. sent "URGENT: DEVICE RECALL" letters (dated 11/10/06) to the US and foreign consignees by UPS overnight. The letters instructed the consignees to inspect their stocks of the instruments and that they return all devices. The letters also instructed the distributors to contact their customers that received the instruments and conduct sub-recalls. Additionally, when requested, ConMed notified the distributor's customers (conducted sub-recalls) by UPS overnight mail. This recall action is to the end user level. Accompanying each letter was an effectiveness check form to be completed by the consignee, and faxed back to ConMed Corp. The instruments are to be returned to ConMed Corp. in Utica, NY. For questions, the consignee can contact Ms. Nancy Crisino by phone at (315) 624-3078 or by fax at (315) 624-3089.
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