Device recall: Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the…
Class II FDA enforcement event 71515. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The Supporter toilet armrest has two Fast Nuts fixing the product to the toilet porcelain. The firm has reports of the two Fast Nuts coming loose and causing the Supporter to become unsteady.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Etac Supply Center Ab started this device recall on 15 Jun 2015. The firm address in the FDA record is in Anderstorp. FDA put the recall in Class II. FDA event 71515 has 1 product record. The first FDA enforcement report date is 22 Jul 2015. The record gives the status Terminated, with the termination date 14 Jul 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Distribution including GA, CT and PA.
Recalling firm
Etac Supply Center Ab, Anderstorp, N/A, Sweden.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2073-2015 | Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armrest can easily be detached. Supporter… | 25 units | Class II | Terminated | 22 Jul 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Jul 2015 | Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing supp | Device | Class II | 1 |
| 23 May 2013 | Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Height adjustable four wheele | Device | Class II | 1 |
| 6 Apr 2012 | Etac Ono Walker, Etac Avant Walker, and Etac Salsa Walker. These products are four-wheeled walkers intended as a walking | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2073-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 71515. https://recallregister.com/fda/ii/71515/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Distribution including GA, CT and PA.
- What quantity of product is in FDA event 71515?
- The FDA record gives this quantity:
25 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 91% of the 1,153 device events that started in 2015 are in Class II.