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…

Read the official notice →
Date
2025-02-12
Country
United States
Brand
Hologic
Product
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The…
Classification
Class II
Units
Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2026-02-18
  2. US
    Drugs & medicalClass II

    Hologic, Inc recalls Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

    Presence of particulates in affected devices that can be deposited into breast tissue during use.

    FDA · DeviceHologic, IncUS Nationwide distribution.Official notice →
  3. 2026-01-21
  4. US
    Drugs & medicalClass II

    Hologic, Inc recalls ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

    Fungal contamination of affected lot with Parengyodontium album.

    FDA · DeviceHologic, IncUS Nationwide distribution.Official notice →
  5. 2025-02-19
  6. US
    Drugs & medicalClass II

    Hologic, Inc recalls Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product…

    Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.

    FDA · DeviceHologic, IncDomestic: Nationwide DistributionOfficial notice →
  7. 2025-01-22
  8. 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 →
  9. 2025-01-01
  10. 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 →
  11. 2024-12-18
  12. US
    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

    FDA · DeviceHologic, IncUS Nationwide distribution.Official notice →
All 21 Hologic recalls →

Other drugs & medical recalls in the United States

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

    Nobel Biocare recalls . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel…

    Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.

    FDA · DeviceNobel BiocareU.S. Nationwide distribution in the states of CA, FL, IL, MA, NJ, NY, OH, PA,…Official notice →
  3. US
    Drugs & medicalClass II

    Belmont Instrument LLC recalls Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or…

    Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set

    FDA · DeviceBelmont Instrument LLCWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice →
  4. US
    Drugs & medicalClass II

    Ethicon, LLC recalls PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue…

    Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and…

    FDA · DeviceEthicon, LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →
  5. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 3 M12 System Code: (1) 722063 (2) 722221

    Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get…

    FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Canada,…Official notice →
  6. US
    Drugs & medicalClass II

    Oxoid Limited recalls Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797

    Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.

    FDA · DeviceOxoid LimitedUS: VA, CA, NE, MA, FL, CA, MA, NH, WA OUS: Austria, Australia, Brazil,…Official notice →
  7. US
    Drugs & medicalClass II

    LivaNova USA, Inc. recalls SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).

    Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline…

    FDA · DeviceLivaNova USA, Inc.US: AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO,…Official notice →
See all drugs & medical recalls →