Home › Conmed Corporation › POOLE
POOLE
Conmed Corporation · Model 0035070 · UDI-DI 10653405000419
GCX
Prescription
10
510(k) clearances
1,734
Adverse events (21 deaths)
38
Recalls
194
Facilities
Description
POOLE Suction Instrument with Removable Sheath and Preattached 6' (1.8 m) Clear Plastic Tubing
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-08 | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| 2026-06-08 | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| 2026-06-08 | Stryker Corporation | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| 2025-12-26 | Cardinal Health 200, LLC | The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, |
| 2025-06-18 | Stryker Corporation | Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. |
| 2024-11-19 | Med Michigan Holding Llc | Incomplete or partial pouch seals, which may result in a breach in the sterility. |
| 2023-12-21 | Cardinal Health 200, LLC | The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment |
| 2023-12-21 | Cardinal Health 200, LLC | The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment |
| 2023-12-21 | Cardinal Health 200, LLC | The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment |
| 2021-04-23 | Synaptive Medical Inc | Due to visible burrs/metal filings affixed along the suction tube inner perimeter. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.