Z-2246-2016Class II

DeVilbiss Model 7305P-D Powered Suction Unit

Name: Z-2246-2016 DeVilbiss Model 7305P-D Powered Suction Unit
Creator: DeVilbiss Healthcare LLC
Published: 2016-05-23
License: https://open.fda.gov/license/

Sunrise Medical, Inc. / initiated 2016-05-23 / Terminated / root cause: design

FDA source

DeVilbiss Healthcare LLC began a recall of DeVilbiss Model 7305P-D Powered Suction Unit on 2016-05-23. FDA classified it as Class II and gives the reason as "A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2246-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-23
Posted: 2016-07-20
Terminated: 2017-05-30
Recalling firm: Sunrise Medical, Inc.
Product: DeVilbiss Model 7305P-D Powered Suction Unit
Product code: JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Reason for recall: A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.
Root cause tag: design
FDA 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 in commerce: 48 units
Distribution: US Distribution to the states of : NC, OH, TX, MO, TN, WI, KY, FL, LA, MN, IN, and SC
Product codes and lots: Serial numbers: PD465146 - PD465193

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2246-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2246-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-20

Product code JCX

K982304Class IIDevilbiss Suction UnitSunrise Medical Hhg, Inc. / cleared 1998-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)