Hologic, Inc 2024-05-15 Health critical FDA
Health · FDA · Recall #FDA-Z-1733-2024
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites… Recall
Issued May 15, 2024 · Hologic, Inc
In May 2024, Hologic, Inc recalled the BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device
What you should do
- 1 Stop using BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Hologic, Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Hologic, Inc
- Category
- Health
- Recall date
- May 15, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide Distribution
- Recall number
- FDA-Z-1733-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Hologic, Inc has 4 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.