Drugs & medicalClass II

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

Read the official notice →
Date
2024-12-18
Country
United States
Brand
Hologic
Product
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Classification
Class II
Units
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2025-02-12
  2. US
    Drugs & medicalClass II

    Hologic, Inc. recalls The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The…

    Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are…

    FDA · DeviceHologic, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →
  3. 2025-01-22
  4. US
    Drugs & medicalClass II

    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 →
  5. 2025-01-01
  6. US
    Drugs & medicalClass II

    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.

    FDA · DeviceHologic, Inc.US: AKOfficial notice →
  7. 2024-12-04
  8. US
    Drugs & medicalClass I

    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.

    FDA · DeviceHologic, IncDomestic: US Nationwide Distribution.Official notice →
  9. 2024-10-02
  10. US
    Drugs & medicalClass II

    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 →
  11. 2024-07-24
  12. US
    Drugs & medicalClass II

    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 →
All 21 Hologic recalls →

Other drugs & medical recalls in the United States

  1. 2024-12-18
  2. US
    Drugs & medicalClass II

    Cardinal Health 200, LLC recalls Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL,…

    Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level…

    FDA · DeviceCardinal Health 200, LLCUS Nationwide. Canada, UAEOfficial notice →
  3. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact…

    The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid…

    FDA · DeviceBeckman Coulter Inc.Foreign distribution to Albania, Australia, Austria, Bahrain, Belgium, Brazil,…Official notice →
  4. US
    Drugs & medicalClass II

    CareFusion 303, Inc. recalls BD Pyxis CII Safe ES, REF: 1116-00

    Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication…

    FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of OK, LA, FL,…Official notice →
  5. US
    Drugs & medicalClass II

    Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV19

    During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a…

    FDA · DeviceMicro-X Ltd.US Nationwide Distribution: TX, CA, OH, ID, WA, AZOfficial notice →
  6. US
    Drugs & medicalClass II

    Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

    Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.

    FDA · DeviceMicro-X Ltd.US Nationwide Distribution: NJ, CA, PROfficial notice →
  7. US
    Drugs & medicalClass II

    Micro-X Ltd. recalls MICRO-X Rover Mobile X-ray System, # MXU-RV35

    Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.

    FDA · DeviceMicro-X Ltd.Worldwide and US Nationwide Distribution: NJ, PR, CAOfficial notice →
See all drugs & medical recalls →