FDA Medical Device Recalls (openFDA)
DeVilbiss Healthcare LLC: DeVilbiss Model 7305P-D Powered Suction Unit
- Recall number
- Z-2246-2016
- Recalling firm
- DeVilbiss Healthcare LLC
- Product
- DeVilbiss Model 7305P-D Powered Suction Unit
- Status
- Terminated
- Initiated
- 2016-05-23
- Posted
- 2016-07-20
- Terminated
- 2017-05-30
- Reason
- A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
- Root cause
- Component design/selection
- Action
- DeVilbiss Healthcare sent an Urgent - Medical Device Recall letter on May 23, 2016, to all affected customers notifying them of the issue. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to isolate all of the affected units included on the serial number list and return for replacement. For further questions, please call (814) 443-7602.
- Quantity
- 48 units
- Distribution
- US Distribution to the states of : NC, OH, TX, MO, TN, WI, KY, FL, LA, MN, IN, and SC
- Lot, serial or model codes
- Serial numbers: PD465146 - PD465193
- 510(k) numbers
- ["K982304"]
- PMA numbers
- not on file
- Product code
- JCX
- Firm FEI
- 2515872
- Firm city
- Somerset
- Firm state
- PA
- 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