Lancaster, NY, United States
Exact Medical Manufacturing, Inc. recalls
1 recall recorded since 2018, most recently on 29 April 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
- 29 April 2021
- Terminated
- 26 May 2022
- Reason
- No 510k for the product to be used in a natural or surgical opening to the body
- Distribution
- US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1918-2021, Z-1909-2021, Z-1923-2021, Z-1914-2021, Z-1917-2021, Z-1924-2021, Z-1907-2021, Z-1913-2021, Z-1916-2021, Z-1919-2021, Z-1922-2021, Z-1910-2021 and 6 more
- Hays Ultrasound kit Item ID: H1000SE
- 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
- Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576
- Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
- Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
- Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664
- Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
- Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
- and 10 more product lines
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.