Recall Z-0328-2025
Hologic, Inc · initiated October 10, 2024
Class I – dangerous or defective products that could cause serious health problems or death
Product
BioZorb Marker. Radiographic soft tissue marker.
Codes / lots: 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…
Reason for recall
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
FDA-determined cause: Device Design
Action taken
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 breasthealth.support@hologic.com. ***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.
Details
- Recall number
- Z-0328-2025
- Initiated
- October 10, 2024
- Posted by FDA
- November 26, 2024
- Product code
- NEU – Marker, Radiographic, Implantable
- Quantity
- 12,710 units
- Distribution
- Domestic: US Nationwide Distribution.
- Recalling firm
- Hologic, Inc, Marlborough, MA