Hologic, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Hologic, Inc
Lot Codes / Batch Numbers
UDI-DI: 15420045514027 Lot 22A0RL Correct Expiration Date is July 8, 2024, but incorrect labels state expiration date of January 20, 2022.
Products Sold
UDI-DI: 15420045514027 Lot 22A0RL Correct Expiration Date is July 8, 2024, but incorrect labels state expiration date of January 20, 2022.
Hologic, Inc is recalling The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft due to Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product ha. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On August 9, 2022, the recalling firm sent out recall letters with subject line "RE: Incorrect expiration date on BioZorb bioabsorbable marker removable label". Customers were instructed to return any unused product from the affected lot to Hologic. Please contact BSHCustomersupport@hologic.com with the number of unused units from Lot#22A20RL that you have. You will be provided a pre paid label to facilitate return. You will also be issued a credit on your account for the returned product. If you wish to reorder product, please place a new order via your preferred procurement method. If material has already been implanted from the affected lot and the patient chart requires updating, Hologic included corrected labels with the recall letter for that purpose.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026