Hologic, Inc recalls BioZorb Marker. Radiographic soft tissue marker.
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
Read the official notice →- Date
- 2024-12-04
- Country
- United States
- Brand
- Hologic
- Product
- BioZorb Marker. Radiographic soft tissue marker.
- Classification
- Class I
- Units
- Domestic: US Nationwide Distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Hologic recalls
- 2025-01-22
US
Hologic, Inc. recalls Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
FDA · DeviceHologic, Inc.AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA,…Official notice →- 2025-01-01
US
Hologic, Inc. recalls Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
- 2024-12-18
US
Hologic, Inc recalls Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
- 2024-10-02
US
Hologic Inc recalls Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as…
Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may…
FDA · DeviceHologic IncWorldwide distribution - US Nationwide and the countries of Belgium, Canada,…Official notice →- 2024-07-24
US
Hologic Inc recalls Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN,…
Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the…
FDA · DeviceHologic IncWorldwide distribution - US Nationwide and the countries of India, Australia,…Official notice →- 2024-05-15
US
Hologic, Inc recalls BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x…
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the…
Other drugs & medical recalls in the United States
- 2024-12-04
US
KCI USA, INC. recalls V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound…
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
FDA · DeviceKCI USA, INC.Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, FL,…Official notice →US
Defibtech, LLC recalls Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View…
Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could…
US
Defibtech, LLC recalls Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on…
Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead…
US
US
Neogen Corporation recalls LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925…
CGMP violations.
FDA · DrugNeogen CorporationProduct sold directly to one distributor consignee, Bob Barker Company, an…Official notice →US