Z-2461-2012Class II

Invacare I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These...

Name: Z-2461-2012 Invacare I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These...
Creator: Invacare Corporation
Published: 2012-08-06
License: https://open.fda.gov/license/

Invacare GmbH / initiated 2012-08-06 / Terminated / root cause: design

FDA source

Invacare Corporation began a recall of Invacare I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These shower chairs are designed for individuals who require... on 2012-08-06. FDA classified it as Class II and gives the reason as "On August 6, 2012, Invacare voluntarily recalled the Invacare I-Fit" Shower Chair (Models 9780, 9781, 9781-1) based on the return, quality and adverse event data received". 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-2461-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-06
Posted: 2012-09-26
Terminated: 2014-02-11
Recalling firm: Invacare GmbH
Product: Invacare I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These shower chairs are designed for individuals who require seating support when bathing or showering and provide comfort and safety in the bathtub.
Product code: KMN Chair And Table, Medical
Reason for recall: On August 6, 2012, Invacare voluntarily recalled the Invacare I-Fit" Shower Chair (Models 9780, 9781, 9781-1) based on the return, quality and adverse event data received.
Root cause tag: design
FDA root cause: Device Design
Action: Invacare sent an "URGENT: RECALL INFORMATION" letter dated August 31, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of any affected product and to call the Recall Support Line at 877-496-5041 for assistance.
Quantity in commerce: 21,168 chairs
Distribution: Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of AUSTRALIA, CANADA, GUAM, ISRAEL, NEW ZEALAND, THAILAND, TRINIDAD AND TOBAGO.
Product codes and lots: 9780, 9781, 9781-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2461-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2461-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-26

Product code KMN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)