Hologic, Inc: Medical Device Recall in 2022 - (Recall #: Z-1858-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable.

Product Classification:

Class II

Date Initiated: August 9, 2022

Date Posted: October 12, 2022

Recall Number: Z-1858-2022

Event ID: 90734

Reason for Recall:

Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing date, and it's different from the one on the shelf box label, which is the correct expiration date.

Status: Ongoing

Product Quantity: 233

Code Information:

UDI-DI: 15420045514027 Lot 22A0RL Correct Expiration Date is July 8, 2024, but incorrect labels state expiration date of January 20, 2022.

Distribution Pattern:

US Nationwide distribution including in the states of FL, IL, MD, NJ, AZ, TX, WA, VA, OK, NC, NH, GA, CA, CT, OH, CO, MI, MO, KS, TN, ID, MS, MT, AL, OR, IA, PA, MA.

Voluntary or Mandated:

Voluntary: Firm initiated