The Recall Desk

Manufacturer

Instrumentation Laboratory

38 recalls in our database name Instrumentation Laboratory as the manufacturing or recalling firm.

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.

1–25 of 38

  • Severity pendingFDA (Devices)·Z-1542-2026·2026-03-18

    GEM Premier 5000; Part No. 00055445008.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1542-2026.

    Product
    GEM Premier 5000; Part No. 00055445008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1539-2026·2026-03-18

    GEM Premier 5000; Model No. 00055430010.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1539-2026.

    Product
    GEM Premier 5000; Model No. 00055430010.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1524-2026·2026-03-18

    GEM Premier 5000 PAK, Part No. 00055360004.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1524-2026.

    Product
    GEM Premier 5000 PAK, Part No. 00055360004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1528-2026·2026-03-18

    GEM Premier 5000 PAK; Part No. 00055407504.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1528-2026.

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

    GEM Premier 5000 PAK; Part No. 00055415004.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1532-2026.

    Product
    GEM Premier 5000 PAK; Part No. 00055415004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1525-2026·2026-03-18

    GEM Premier 5000 PAK; Part No. 00055360008.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1525-2026.

    Product
    GEM Premier 5000 PAK; Part No. 00055360008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1534-2026·2026-03-18

    GEM Premier 5000; Part No. 00055415008.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1534-2026.

    Product
    GEM Premier 5000; Part No. 00055415008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1535-2026·2026-03-18

    GEM Premier 5000; Part No. 00055415010.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1535-2026.

    Product
    GEM Premier 5000; Part No. 00055415010.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1531-2026·2026-03-18

    GEM Premier 5000 PAK; Part No. 00055407511.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1531-2026.

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

    GEM Premier 5000; Part No. 00055430011.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1540-2026.

    Product
    GEM Premier 5000; Part No. 00055430011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1529-2026·2026-03-18

    GEM Premier 5000 PAK; Part No. 00055407508.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1529-2026.

    Product
    GEM Premier 5000 PAK; Part No. 00055407508.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1530-2026·2026-03-18

    GEM Premier 5000 PAK; Part No. 00055407510.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1530-2026.

    Product
    GEM Premier 5000 PAK; Part No. 00055407510.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1538-2026·2026-03-18

    GEM Premier 5000; Part No. 00055430008.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1538-2026.

    Product
    GEM Premier 5000; Part No. 00055430008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1526-2026·2026-03-18

    GEM Premier 5000 PAK; Part No. 00055360010.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1526-2026.

    Product
    GEM Premier 5000 PAK; Part No. 00055360010.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1541-2026·2026-03-18

    GEM Premier 5000; Part No. 00055445004.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1541-2026.

    Product
    GEM Premier 5000; Part No. 00055445004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1533-2026·2026-03-18

    GEM Premier 5000; Part No. 00055415005.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1533-2026.

    Product
    GEM Premier 5000; Part No. 00055415005.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1543-2026·2026-03-18

    GEM Premier 5000; Part No. 00055445010 & 00055445011.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1543-2026.

    Product
    GEM Premier 5000; Part No. 00055445010 & 00055445011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1527-2026·2026-03-18

    GEM Premier 5000 PAK; Part No. 00055360011.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1527-2026.

    Product
    GEM Premier 5000 PAK; Part No. 00055360011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1536-2026·2026-03-18

    GEM Premier 5000; Part No: 00055415011.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1536-2026.

    Product
    GEM Premier 5000; Part No: 00055415011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-1537-2026·2026-03-18

    GEM Premier 5000; Part No. 00055430004.

    Pending LLM rewrite. Source: FDA_DEVICE Z-1537-2026.

    Product
    GEM Premier 5000; Part No. 00055430004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Devices)·Z-2323-2025·2025-08-20

    HemosIL LMW Heparin Controls; Part Number: 0020300200;

    Pending LLM rewrite. Source: FDA_DEVICE Z-2323-2025.

    Product
    HemosIL LMW Heparin Controls; Part Number: 0020300200;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1020-2025·2025-02-05

    HemosIL Heparin Calibrators Recalled Over Quality Control Test Failures

    Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.

    Product
    HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0357-2024·2023-11-29

    Medical Device Cartridges Recalled for Blood Oxygen Reading Errors

    Instrumentation Laboratory is recalling GEM Premier 3000 PAK cartridges due to a defect that can produce falsely high blood oxygen readings. The inaccuracy may prevent detection of dangerously low oxygen levels and delay necessary treatment.

    Product
    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
    Category
    Medical Device
    Distribution
    3 states