Recall Record

Batesville, IN, United States

Med-Mizer, Inc. recalls

2 recalls recorded since 2018, most recently on 3 February 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
3 February 2023
Reason
Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side.
Distribution
Awaiting consignee list from the recalling firm.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1205-2023, Z-1204-2023

Terminated Class II Medical devices

Recall started
25 July 2018
Terminated
11 October 2019
Reason
Under certain conditions, when pivoting bed to the extreme left there are situations where the wire/cables may become pinched. A failure would result in the resident requiring to be transferred to a different bed until repairs can be made
Distribution
The products were distributed to the following US states: AR, AZ, FL, GA, IA, ID, IL, IN, KY, ME, MI, MN, MO, NC, ND, NE, NM, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI. The products were distributed to the following foreign countries: Canada, China, and Denmark.
Initiated
Voluntary: Firm initiated
Recall number
Z-3183-2018

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.