Reported Dec 4, 2024 · Ongoing
BioZorb Marker. Radiographic soft tissue marker.
Hologic, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc · 250 Campus Dr · Marlborough, MA · 01752-3020
Is this the product you have?
- BioZorb Marker. Radiographic soft tissue marker.
- Lot codes and dates
Model No. F0405F0404F0331F0231F0221F0304F0303F0203F0202
- UDI-DI
134 of 134 codes
154200455140651542004551405815420045514041154200455140341542004551402715420045514010154200455140031542004551399015420045513983Lot No. 22E24RH23A09RK23L23RP22E24RG23A09RJ23E03R23G28RW22F06RL22G26RQ22K25RA23A09RH23A30RP23C02RJ23H25RW23K04RC23K31RG24A30RG22D21RBB22F06RK22F29RK22G26RP22H24RM22J26RG22K25R22L22R22M20RM23A26RV23C02RH23E27RF23F29RT23H03R23H25RU23K04RA23L23RK24B02RD24B27RK22D21RAA22E24RA22F29RJ22G26RN22H24RL22J26RF22K21R22L22RA22M20RL23A26RU23C02RG23C30RQ23E03RA23F29RP23G28RV
- Amount recalled
- 12,710 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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