The Recall Desk

Manufacturer

Bioseal Corporation

5 recalls in our database name Bioseal Corporation as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
2
Most recent
2021-05-26

Of the 5 recalls from Bioseal Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (40%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • SevereFDA (Devices)·Z-1623-2021·2021-05-26

    Bioseal Chest Tube Insertion Tray Recalled for Mold Contamination

    Bioseal Corporation is recalling 140 units of Chest Tube Insertion Trays because the included ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.

    Product
    Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1624-2021·2021-05-26

    Bioseal Central Line Dressing Kits Recalled for Potential Mold Growth

    Bioseal Corporation is recalling 580 Central Line Dressing Kits because the included ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.

    Product
    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1622-2021·2021-05-26

    Bioseal Central Line Dressing Kits Recalled for Mold Contamination

    Bioseal Corporation is recalling Central Line Dressing Kits because the ChloraPrep applicator may allow Aspergillus penicillioides growth, potentially breaching package integrity.

    Product
    Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2795-2020·2020-08-19

    Bioseal Trachea Extenders Recalled for Stress Cracks and Leakage Risk

    Bioseal Corporation is recalling 900 units of Trachea Extenders due to stress cracks that may cause breathing system leakage, potentially preventing prescribed ventilation from reaching patients.

    Product
    Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0085-2018·2017-11-15

    Bioseal Custom Surgical Kits Recalled for Expired Iodine Prep Pads

    Bioseal Corporation is recalling custom surgical kits containing Aplicare Providone Iodine Prep Pads due to incorrect expiration dates.

    Product
    Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray,
    Category
    Medical Device
    Distribution
    4 states