Lakewood Ranch, FL, United States
Mercedes Medical, Inc. recalls
1 recall recorded since 2018, most recently on 10 June 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 June 2021
- Terminated
- 14 August 2023
- Reason
- No 510(k) clearance
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, Ne
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2067-2021, Z-2066-2021
- Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.
- Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
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.