Lower risk Medical device recall · FDA · Published August 9, 2022

Hologic BioZorb LP Marker: Expired Labels Risk Incorrect Use

Hologic recalls BioZorb LP markers with expired labels that show incorrect dates. The product may be used incorrectly due to outdated expiration dates on removable labels.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1858-2022Medical device Hologic ›

Lower-risk 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.

Take action

Contact the company

Recalling firmHologic, Inc250 Campus Dr · Marlborough, MA 01752-3020

✎ GovInfoNow plain-language explainer

Hologic recalls BioZorb LP markers that have removable labels showing an expired date (January 20, 2022) instead of the correct expiration date (July 8, 2024). Using these markers could lead to improper medical procedures if the expiration date is mistaken for the actual expiration. Read more at govinfonow.com/recall/60204-hologic-biozorb-lp-marker-expired-labels-risk-incorrect-use.

Source Summary by GovInfoNow · govinfonow.com/recall/60204-hologic-biozorb-lp-marker-expired-labels-risk-incorrect-use · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1858-2022

Cite this page

“Hologic BioZorb LP Marker: Expired Labels Risk Incorrect Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60204-hologic-biozorb-lp-marker-expired-labels-risk-incorrect-use. Based on FDA recall #Z-1858-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1858-2022%22&limit=1).

The FDA announced on August 9, 2022, that Hologic, Inc. is recalling The BioZorb LP Marker because removable labels displayed an incorrect expiration date of January 20, 2022, instead of the correct July 8, 2024. This Class II recall affects 233 units distributed nationwide.

How to tell if you have it

Brand: Hologic
Product: The BioZorb LP Marker
Product number: F0221
Lot code: 22A0RL
UDI-DI: 15420045514027

The hazard

The 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.

Context

GovInfoNow's records show Hologic, Inc has 30 other recalls on record since 2017-06-27. Other recent recalls of similar products include BD Ready-to-Use Hydrophilic Catheter 14 Fr (2025-11-29), B Braun Discofix Four Way Stopcock Recall (2026-08-04), and Cardinal Health ChemoPlus Gowns Recall (2025-11-12).

How to tell if you have this one

Check the removable label on the BioZorb LP marker for an expiration date of January 20, 2022. The correct expiration date is July 8, 2024, as listed on the shelf box label.

Brand
Hologic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Label Dates
Verify the expiration date on the removable label matches the correct expiration date of July 8, 2024 as shown on the shelf box label.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 28 states.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Iowa, Kansas, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, New Hampshire, New Jersey, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington.

Recall timeline

FDA published this recall 2 months after the firm started it.

Aug 9, 2022Firm started the recall
Sep 30, 2022FDA classified it Class II
Oct 12, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury from using this marker?

The hazard is low risk as the issue involves incorrect labeling rather than a physical defect that could cause immediate harm.

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Link to this recall

<a href="https://govinfonow.com/recall/60204-hologic-biozorb-lp-marker-expired-labels-risk-incorrect-use">Hologic BioZorb LP Marker: Expired Labels Risk Incorrect Use (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1858-2022 (August 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1858-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.