The Recall Desk

Hazard

Operational Disruption recalls

22 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
22
Critical
0
Severe
0
Most recent
2026-03-18

Of the 22 operational disruption recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all operational disruption recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–22 of 22

  • HighFDA (Devices)·Z-1535-2026·2026-03-18

    GEM Premier 5000 part 00055415010 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415010 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055415010.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1526-2026·2026-03-18

    GEM Premier 5000 PAK part 00055360010 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360010 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055360010.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1524-2026·2026-03-18

    GEM Premier 5000 PAK part 00055360004 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK, Part No. 00055360004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1527-2026·2026-03-18

    GEM Premier 5000 PAK part 00055360011 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055360011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1525-2026·2026-03-18

    GEM Premier 5000 PAK part 00055360008 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055360008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1539-2026·2026-03-18

    GEM Premier 5000 cartridges may eject repeatedly during analyzer warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 analyzers after confirmed complaints that GEM PAK cartridges may show increased Process Control Solution Not Detected errors during warm-up.

    Product
    GEM Premier 5000; Model No. 00055430010.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1529-2026·2026-03-18

    GEM Premier 5000 PAK part 00055407508 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407508 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055407508.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2026·2026-03-18

    GEM Premier 5000 PAK part 00055407511 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407511 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055407511.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1540-2026·2026-03-18

    GEM Premier 5000 part 00055430011 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055430011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1528-2026·2026-03-18

    GEM Premier 5000 PAK part 00055407504 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407504 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055407504.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2026·2026-03-18

    GEM Premier 5000 PAK part 00055415004 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055415004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055415004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1542-2026·2026-03-18

    GEM Premier 5000 part 00055445008 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055445008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055445008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2026·2026-03-18

    GEM Premier 5000 part 00055430004 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055430004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1538-2026·2026-03-18

    GEM Premier 5000 part 00055430008 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055430008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1536-2026·2026-03-18

    GEM Premier 5000 part 00055415011 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No: 00055415011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2026·2026-03-18

    GEM Premier 5000 part 00055415005 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415005 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055415005.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2026·2026-03-18

    GEM Premier 5000 PAK part 00055407510 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407510 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055407510.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1541-2026·2026-03-18

    GEM Premier 5000 part 00055445004 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055445004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055445004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2026·2026-03-18

    GEM Premier 5000 parts 00055445010 and 00055445011 may eject cartridges

    Instrumentation Laboratory is recalling GEM Premier 5000 parts 00055445010 and 00055445011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up.

    Product
    GEM Premier 5000; Part No. 00055445010 & 00055445011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1534-2026·2026-03-18

    GEM Premier 5000 part 00055415008 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055415008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1688-2025·2025-05-07

    IceSeed CX Cryoablation Needles Recalled for Demo Programming Issue

    Boston Scientific is recalling IceSeed 1.5 CX cryoablation needles manufactured between April 2024 and February 2025 because they were programmed with demo settings instead of commercial settings. If disconnected and reconnected during use, the system will prompt unnecessary recalibration testing.

    Product
    IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1646-2015·2015-06-03

    Siemens SOMATOM Perspective CT Scanner Software Recall

    Siemens is recalling 75 SOMATOM Perspective CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.

    Product
    SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide