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BioZorb recallZ-0328-2025 · Hologic, Inc · initiated Oct 10, 2024

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

FDA root cause category: Device Design

What the company is doing

Consignees were sent an URGENT: MEDICAL DEVICE RECALL letter by mail dated 10/24/24. The notification instructs consignees to quarantine all affected devices and share the recall notification with all surgeons in their practice that have used or planned to use the BioZorb Marker. Additionally, if product was further distributed the notice is to be forwarded to those customers. Affected devices will be returned to Hologic and coordination of return will be initiated by return of the Customer Response Form. Healthcare providers are recommended to be aware of reports of serious adverse events following the placement of the BioZorb Marker devices in breast tissue and to continue to monitor patients for signs of any adverse events. BioZorb Markers are not cleared to fill space in the tissue or improve cosmetic outcomes after procedures. Patients are recommended to contact their healthcare provider if they experience any adverse events following the placement of their BioZorb marker. Hologic states that there is no need to undergo explantation of the device unless advised by your healthcare provider. Patients who have received the BioZorb Marker and/or your provider is planning radiation therapy treatments, discuss the possible risks with your provider. Report any problems/complications and direct any questions regarding this recall to Hologic at [email protected]. ***Update May 5, 2026: On April 6, 2026 A Follow-up notification as an updated resource for clinicians who have previously used Biozorb breast markers or are currently caring for patients implanted with BioZorb markers. Hologic recalled and removed from market BioZorb and BioZorb LP on October 24, 2024; therefore, all patients with these implants have had them in place for at least one year. The original notification that was distributed as a part of the previous recall can be found as an appendix to this resource.

Recall details

Recall number
Z-0328-2025
Status
Open, Classified
Initiated by the company
Oct 10, 2024
Posted by the FDA
Nov 26, 2024
Recalling firm
Hologic, Inc
Quantity
12,710 units
Product code
NEU
FDA submissions
K143484, K152070
Distribution
Domestic: US Nationwide Distribution.

Product description

BioZorb Marker. Radiographic soft tissue marker.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Model No. F0405, F0404, F0331, F0231, F0221, F0304, F0303, F0203, F0202; UDI-DI: 15420045514065, 15420045514058, 15420045514041, 15420045514034, 15420045514027, 15420045514010, 15420045514003, 15420045513990, 15420045513983; Lot No. 22E24RH, 23A09RK, 23L23RP, 22E24RG, 23A09RJ, 23E03R, 23G28RW, 22F06RL, 22G26RQ, 22K25RA, 23A09RH, 23A30RP, 23C02RJ, 23H25RW, 23K04RC, 23K31RG, 24A30RG, 22D21RBB, 22F06RK, 22F29RK, 22G26RP, 22H24RM, 22J26RG, 22K25R, 22L22R, 22M20RM, 23A26RV, 23C02RH, 23E27RF, 23F29RT, 23H03R, 23H25RU, 23K04RA, 23L23RK, 24B02RD, 24B27RK, 22D21RAA, 22E24RA, 22F29RJ, 22G26RN, 22H24RL, 22J26RF, 22K21R, 22L22RA, 22M20RL, 23A26RU, 23C02RG, 23C30RQ, 23E03RA, 23F29RP, 23G28RV, 23H25RV, 23K02RB, 23K31RD, 23L23RH, 24A08RY, 24B01R, 24B27RL, 24C22RN, 22D21RZ, 22E24RB, 22F25RF, 22G26RM, 22H24RK, 22J26RD, 22K19RW, 22L22RB, 23C02RK, 23E25RY, 23F29RS, 23H24RP, 23K04RB, 23K31RF, 23L23RJ, 22D21RY, 22E24R, 22F25RD, 22G26RL, 22H22RT, 22J26RC, 22K19RV, 22L22RC, 23A09RN, 23H03RA, 23H31R, 23K04RD, 23K25RM, 22D21RX, 22E20RAA, 22F21R, 22G21RM, 22H22RS, 22J22RBB, 22K19RU, 22L22RF, 23A09RM, 23A30RQ, 23B24RZ, 23C30RP, 23D27RJ, 23E31RD, 23F28RZ, 23G31RJ, 23H24RQ, 23K02RA, 23K25RN, 22D20RV, 22E20RZ, 22F16RV, 22G21RL, 22H20R, 22J22RAA, 22K19RT, 22K25RB, 22L22RD, 23A09RL, 23B24RY, 23C28RJ, 23D27RH, 23E30RF, 23F29RQ, 23G31RH, 23H24RN, 23K02R, 23K25RL.

Devices named in this recall

9 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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