FDA Device Intelligence
HomeDevice types › GBX

Catheter, Irrigation

FDA product code GBX · Class 1 · General, Plastic Surgery

1,318
Registered devices
5,795
Adverse events
82
Recalls
77
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-03-05Cook IncorporatedProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2025-11-07Rocket Medical PlcIFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2025-11-07Rocket Medical PlcIFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2025-11-07Rocket Medical PlcIFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2025-11-07Rocket Medical PlcIFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2025-11-07Rocket Medical PlcIFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2025-11-07Rocket Medical PlcIFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2024-03-27Cardinal Health 200, LLCCardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users befo
2024-03-27Cardinal Health 200, LLCCardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users befo
2024-03-27Cardinal Health 200, LLCCardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users befo

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 docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.