The Recall Desk

Hazard

Functional Defect recalls

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

What the numbers show

Total
293
Critical
0
Severe
2
Most recent
2026-08-26

Of the 293 functional defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (1%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all functional defect 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.

1–25 of 293

  • HighFDA (Devices)·Z-2963-2026·2026-08-26

    Maquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission

    Maquet Critical Care AB is recalling nine Y Sensor Modules for the SERVO-U/-N ventilator systems because they did not undergo required electrical safety and functional tests during production.

    Product
    GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2863-2026·2026-08-12

    Stryker Ahto Tube Set Recalled for Handpiece Leaking During Use

    Stryker is recalling 41,052 Ahto Tube Sets worldwide due to reports of handpiece leaking during use.

    Product
    STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2866-2026·2026-08-12

    Stryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use

    Stryker is recalling Strykeflow Suction/Irrigator PS devices due to reports of leaking from the handpiece during use.

    Product
    STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1866-2026·2026-04-29

    Angiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk

    Angiodynamics is recalling the Soft-Vu Angiographic Catheter, Kumpe, Non-Braided due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.

    Product
    Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1631-2025·2025-05-07

    GE Healthcare Carestation Anesthesia Systems Ventilation Defect Recall

    Certain GE Healthcare Carestation anesthesia delivery systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode. Affected systems can still be used safely in Pressure Control Ventilation or Manual ventilation modes.

    Product
    GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1624-2025·2025-05-07

    GE Healthcare CARESTATION anesthesia systems ventilation malfunction recall

    GE Healthcare CARESTATION 620 A1 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Effective ventilation is available in Pressure Control or Manual ventilation modes.

    Product
    GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1542-2025·2025-04-16

    Stryker HoloBlueprint Application Medical Device Software Functionality Recall

    Stryker is recalling the HoloBlueprint Application (Catalog Number MRUE001) for Total Shoulder Arthroplasty due to software and instrumentation malfunctions that prevent the system from meeting its intended use.

    Product
    stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1276-2024·2024-03-13

    ConvaTec Natura Stomahesive surgical ostomy system pouch-flange coupling mismatch

    ConvaTec Natura Stomahesive ostomy kits contain a 45mm flange but 57mm pouch, creating an incompatible coupling. The mismatch prevents the components from fitting together properly.

    Product
    ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0013-2024·2023-10-11

    Guider Softip Guide Catheter with Incorrect Tip Curve Shape

    Boston Scientific is recalling Guider Softip Guide Catheters due to an incorrect tip curve shape that differs from the labeled specification. The affected units may not perform as intended during cardiac procedures.

    Product
    Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2044-2023·2023-07-05

    Virtual reality therapy device software malfunction prevents treatment progression

    RelieVR VR behavioral therapy device software may malfunction, preventing progression to the next treatment session. No injuries have been reported.

    Product
    RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1283-2023·2023-03-29

    DeRoyal Suction Canister Recalled Due to Lid Shrinkage Seal Defect

    DeRoyal SafeLiner Suction Canister model PHESL-1000B is being recalled due to lid shrinkage that prevents proper vacuum seal formation and maintenance. The recall affects 27,200 devices distributed across multiple US states.

    Product
    DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0130-2023·2022-11-02

    ConvaTec Ostomy Pouch Recalled for Impaired Release Liner Functionality

    ConvaTec is recalling 2,611 units of its Active Life ostomy pouch due to impaired release liner functionality. The defect may affect product performance and seal integrity.

    Product
    ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output following a colostomy or ileostomy procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1290-2022·2022-07-06

    Central venous catheter recalled for incorrect gravity flow rates

    Arrow International is recalling the Arrow Three-Lumen CVC due to incorrect gravity flow rates on the product lidstock. The defect may affect fluid and medication delivery through the catheter.

    Product
    Arrow Three-Lumen CVC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1667-2021·2021-05-26

    Bard Access Systems Recalls Groshong NXT ClearVue Catheters Due to Connector Defects

    Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.

    Product
    REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107891 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1666-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recall for Connector Defects

    Bard Access Systems is recalling specific Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.

    Product
    REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UDI: (01)10801741102704 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1669-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recall for Connector Defects

    Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters due to connector defects that may prevent proper catheter passage or locking.

    Product
    REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1668-2021·2021-05-26

    Bard Access Systems Recalls Groshong NXT ClearVue Catheter Kits

    Bard Access Systems is recalling specific Groshong NXT ClearVue Catheter Basic Kits because the distal connector may be defective, preventing proper catheter passage or locking.

    Product
    REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086998 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1656-2021·2021-05-26

    Bard Access Systems Recalls Groshong NXT ClearVue Catheters Due to Connector Defects

    Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.

    Product
    REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1524-2021·2021-05-12

    DJO EMPOWR KNEE Femoral Sizer Recalled Due to Incorrect Assembly

    Encore Medical is recalling 16 DJO EMPOWR KNEE Femoral Sizers because incorrect assembly caused the size-indicating windows to face the wrong direction.

    Product
    DJO EMPOWR KNEE Femoral Sizer
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1500-2021·2021-05-05

    Nextremity Solutions Recalls InCore Lapidus Disposable Kits Due to Drill Bushing Defect

    Nextremity Solutions is recalling 111 units of the InCore Lapidus Disposable Kit 28mm Left because a drill bushing defect may prevent surgeons from completing the intended procedure.

    Product
    InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1300-2021·2021-03-31

    Cardinal Health Recalls In-View Clear Leggings Due to Manufacturing Variance

    Cardinal Health is recalling In-View Clear Leggings Sterile because a manufacturing variance causes the plastic film to stick, potentially preventing proper application.

    Product
    In-View Clear Leggings Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1304-2021·2021-03-31

    Cardinal Health Recalls Femoral Angiography Drapes Due to Sticking Defect

    Cardinal Health is recalling non-sterile femoral angiography drapes because a manufacturing defect causes them to stick, preventing proper application.

    Product
    Femoral Angiography Drape Bulk Non-Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1302-2021·2021-03-31

    Cardinal Health Recalls In-View Clear Leggings Due to Sticking Defect

    Cardinal Health is recalling In-View Clear Leggings because a manufacturing variance causes the plastic film to stick, preventing proper application.

    Product
    In-View Clear Leggings Bulk Non-Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1255-2021·2021-03-24

    R&D Systems Recalls Quantikine IVD Human sTfR Immunoassay Kits

    R&D Systems is recalling 156 Quantikine IVD Human sTfR Immunoassay kits due to low standard signals and out-of-specification controls.

    Product
    Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1172-2021·2021-03-10

    Barco Diagnostic Radiology Display Recalled for Lack of DICOM Compliance

    Barco N.V. is recalling MDNC-3421 diagnostic radiology displays because they were shipped without being DICOM-compliant. These units will not pass required acceptance tests.

    Product
    Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
    Category
    Medical Device
    Distribution
    1 state