Fort Myers, FL, United States
Merits Holdings Co. dba Merits Health Products, Inc. recalls
2 recalls recorded since 2018, most recently on 1 April 2021. 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
- 1 April 2021
- Reason
- Seat baseplate pin has broken in the field.
- Distribution
- Distributed nationwide to AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IO, KS, KY, LA, MN, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT, VA, WA, WV, WI and internationally to Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1504-2021, Z-1505-2021
Terminated Class II Medical devices
- Recall started
- 2 March 2020
- Terminated
- 18 September 2023
- Reason
- Pinion gear may disengage from track allowing lift to slip or jolt.
- Distribution
- US Nationwide distribution in the states of AZ, CA, CT, FL, GA, IN, MA, MD, ME, MO, NC, OH, PA, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1632-2020
- Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
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.