BioZorb recallZ-1858-2022 · Hologic, Inc · initiated Aug 9, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Incorrect or no expiration date
What the company is doing
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.
Recall details
- Recall number
- Z-1858-2022
- Status
- Open, Classified
- Initiated by the company
- Aug 9, 2022
- Posted by the FDA
- Sep 30, 2022
- Recalling firm
- Hologic, Inc
- Quantity
- 233
- Product code
- NEU
- FDA submissions
- K152070
- 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 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.
Code information (models, lots, serial numbers)
UDI-DI: 15420045514027 Lot 22A0RL Correct Expiration Date is July 8, 2024, but incorrect labels state expiration date of January 20, 2022.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BioZorb F0221Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE3 recalls15 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K152070 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- BioZorb F0231Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0331Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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