FDA Medical Device Recalls (openFDA)
EMG Technology Co., Ltd.: Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.
- Recall number
- Z-2642-2014
- Recalling firm
- EMG Technology Co., Ltd.
- Product
- Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.
- Status
- Terminated
- Initiated
- 2014-08-03
- Posted
- 2014-09-13
- Terminated
- 2015-08-25
- Reason
- suction canister lids may have occluded ports.
- Root cause
- Nonconforming Material/Component
- Action
- A recall letter, dated August 6, 2014, was sent via email which identified the product, problem, and actions to be taken.
- Quantity
- 1452
- Distribution
- US Distribution in IL.
- Lot, serial or model codes
- Product Model No: SUAOI Serial Number ranges: SUI4B01391-SU14B02117. SU14C00556-SU14C01280
- 510(k) numbers
- ["K042349"]
- PMA numbers
- not on file
- Product code
- JCX
- Firm FEI
- 3003803075
- Firm city
- Taichung
- Firm state
- not on file
- Firm country
- Taiwan
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