Hologic BioZorb Radiographic Marker Recalled Due to Serious Injury Reports
Hologic has recalled 12,710 BioZorb Markers nationwide after receiving reports of serious complications including infection, device migration, and device erosion. The FDA classified this as a Class I recall.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall with reports of serious injuries including infection, device migration, and device erosion. FDA Class I classification alone requires a minimum severity of 4, and the documented serious complications justify the Severe rating.
Plain-English summary
Hologic, Inc. has recalled BioZorb Markers, radiographic soft tissue markers used in medical imaging procedures. The recall affects approximately 12,710 units distributed nationwide across the United States. Multiple model numbers and lot numbers are affected.
The FDA classified this as a Class I recall after the company received reports of adverse events and serious complications associated with the device. Reported complications include pain, infection, rash, device migration, device erosion, seroma, and discomfort.
Patients who received a BioZorb Marker and healthcare providers with affected inventory should contact Hologic, Inc. for instructions on device identification and management. Patients experiencing symptoms such as pain, infection, or rash at the implant site should seek medical attention immediately.
The recalled product
- Product
- BioZorb Marker. Radiographic soft tissue marker.
- Manufacturer
- Hologic, Inc
- Affected units
- 12,710
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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