FDA Medical Device Recalls (openFDA)
Cook Medical Incorporated: EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
- Recall number
- Z-1832-2024
- Recalling firm
- Cook Medical Incorporated
- Product
- EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
- Status
- Open, Classified
- Initiated
- 2024-04-01
- Posted
- 2024-05-16
- Terminated
- not on file
- Reason
- Devices may contain elevated levels of bacterial endotoxin.
- Root cause
- Nonconforming Material/Component
- Action
- On April 01, 2024, Cook Ireland Ltd.(CIRL) initiated a field action for the EchoTip Ultra High Definition Ultrasound Access Needle (ECHO-HD-19-A) and EchoTip Ultra Endoscopic Ultrasound Needle (ECHO-19). Cook Ireland Ltd has identified 9 devices located outside of the United States (US) that are associated with the issue and has initiated a voluntary recall due to the potential of elevated levels of bacterial endotoxins on the devices. No US customers were impacted by this Field Safety Corrective Action (FSCA). No monitoring will be required as US consignees are not impacted by this recall. Effectiveness checks for this recall will not be necessary as US Consignees were not impacted by the distribution.
- Quantity
- 1 Unit OUS
- Distribution
- International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
- Lot, serial or model codes
- Catalogue Number: ECHO-HD-19-A; GPN: G52012; UDI/DI: 00827002520127; Lot Numbers: C2145003 and C2144407.
- 510(k) numbers
- ["K092359"]
- PMA numbers
- not on file
- Product code
- FCG
- Firm FEI
- 3005580113
- Firm city
- Bloomington
- Firm state
- IN
- 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