FDA Device Recall Z-0328-2025

Hologic, Inc · Marlborough, MA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

BioZorb Marker. Radiographic soft tissue marker.

Lot / serial / GTIN: 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.

Quantity: 12,710 units

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.

Recall record

Recall number: Z-0328-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Domestic: US Nationwide Distribution.
Recall initiated: 2024-10-10
Classified by FDA Center: 2024-11-26
FDA published: 2024-12-04
Recalling firm: Hologic, Inc
Firm location: Marlborough, MA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All device recalls