Z-1858-2022Class II

The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue...

Name: Z-1858-2022 The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue...
Creator: Hologic, Inc
Published: 2022-08-09
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2022-08-09 / Open, Classified / root cause: labeling and UDI

FDA source

Hologic, Inc began a recall of 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... on 2022-08-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1858-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-09
Posted: 2022-09-30
Recalling firm: Hologic, Inc.
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.
Product code: NEU Marker, Radiographic, Implantable
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.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: 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 [email protected] 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.
Quantity in commerce: 233
Distribution: 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.
Product codes and lots: UDI-DI: 15420045514027 Lot 22A0RL Correct Expiration Date is July 8, 2024, but incorrect labels state expiration date of January 20, 2022.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1858-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1858-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-12	2022-09-30

Product code NEU

K152070Class IIBioZorb LP MarkerFocal Therapeutics / cleared 2015-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)