Bristol, CT, United States
Beekley Corporation recalls
1 recall recorded since 2018, most recently on 13 June 2018. 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
- 13 June 2018
- Terminated
- 13 November 2018
- Reason
- There is a potential for imaging artifact to mimic calcifications on patient's mammograms
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2831-2018, Z-2832-2018, Z-2830-2018
- S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.
- TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.
- O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
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.