The Recall Desk

Hazard

Assembly Defect recalls

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

What the numbers show

Total
110
Critical
0
Severe
12
Most recent
2026-07-01

Of the 110 assembly 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 12 (11%) 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 assembly 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.

26–50 of 110

  • HighFDA (Devices)·Z-1209-2024·2024-03-06

    Colonoscope Recall: Missing Protective Adhesive May Cause Device Failure

    Olympus Corporation is recalling 18 colonoscopes with missing adhesive that protects against physical stress. The missing protective adhesive could allow device failure under vibration, temperature fluctuation, or shock.

    Product
    Colonoscope, Model Number PCF-H180AL.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2024·2024-03-06

    Olympus colonoscope PCF-H190TL recalled for missing protective adhesive

    Olympus has recalled certain repaired colonoscope models lacking protective adhesive that could fail under vibration, temperature, or severe shock loads. Affected models include the PCF-H190TL, distributed nationwide.

    Product
    Colonoscope, Model Number PCF-H190TL.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2024·2024-03-06

    Colonoscope Model PCF-Q180AL Recalled Due to Missing Protective Adhesive

    Olympus Corporation of the Americas is recalling Colonoscope Model PCF-Q180AL units that were assembled without protective adhesive. This missing adhesive protects the device from vibration, temperature fluctuations, and physical shock during use.

    Product
    Colonoscope, Model Number PCF-Q180AL.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1150-2024·2024-02-28

    Epidural Tray Kits Recalled for Wrong Connector Type

    B. Braun Medical recalls 3,890 PERIFIX epidural trays nationwide due to filter straws with incompatible neuraxial connectors instead of standard Luer connectors.

    Product
    Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anestheti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1009-2024·2024-02-14

    Water Filter MAJ-2318 May Be Incorrectly Assembled, Risking Infection

    Olympus MAJ-2318 water filters may be assembled incorrectly, allowing unfiltered tap water to contaminate reprocessed endoscopes and expose patients to infection risk.

    Product
    Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0693-2024·2024-01-24

    Percussionaire Distal Phasitron respiratory device with reservoir bag assembly defect recalled

    Percussionaire Corporation recalled 195 Distal Phasitron devices after finding the breathing circuit reservoir bag may be assembled at the wrong attachment point, potentially affecting therapy delivery.

    Product
    Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0610-2024·2023-12-27

    LITe Decompression Snake Arm cannot attach due to incorrect clamp component

    Stryker Spine is recalling 9 units of the LITe Decompression Snake Arm due to an incorrect clamp component that prevents proper attachment to the arm post shaft. Affected units were distributed in the US and internationally.

    Product
    LITe Decompression Snake Arm, REF 48080230
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0532-2024·2023-12-20

    Shoulder Implant Recall: RSP Glenoid Baseplate Assembly Defect

    Encore Medical recalls RSP Glenoid Baseplate shoulder implants due to a manufacturing defect in the hex engagement mechanism. The defect could prevent proper installation of the device.

    Product
    RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0113-2024·2023-10-25

    Stryker Tornier Reversed Glenoid Baseplate Recalled for Manufacturing Defect

    One lot of Stryker Tornier Perform Reversed Glenoid Baseplate components was manufactured with incorrect 6mm spacers instead of 3mm, preventing proper assembly. The defect affects 30 units distributed across ten US states.

    Product
    stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2475-2023·2023-09-06

    LIF AMP Adjustable Awl Recalled for Assembly Defect Preventing Depth Control

    Alphatec Spine is recalling the LIF AMP Adjustable Awl due to an assembly defect preventing the locking feature from engaging. This prevents proper depth control during surgery and risks dural tears, vascular injury, and neurologic damage.

    Product
    LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2002-2023·2023-07-05

    Perifix Epidural Anesthesia Kits Recalled for Incorrect Filter Straw

    B. Braun Medical recalled 16,070 Perifix epidural anesthesia kits that were assembled with an incorrect filter straw. The kits were distributed nationwide.

    Product
    Perifix¿ / Epidural anesthesia kit (10 count carton)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1474-2023·2023-05-10

    SafeLight Fiber Optic Cable Recall Due to Assembly Defect

    Stryker Corporation is recalling SafeLight Fiber Optic Cables due to insufficient epoxy on the proximal end, which can cause light output failure and potentially delay surgical procedures.

    Product
    SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1276-2022·2022-07-13

    Clean Catch Urine Kit Recalled Due to Improper Assembly

    American Contract Systems is recalling 274,400 Clean Catch Urine Kits due to improper assembly by potentially untrained individuals. The FDA classified this as a Class I recall.

    Product
    Clean Catch Urine Kit NS 178489, AHMU58A
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1247-2022·2022-06-15

    GMK Sphere CR Size 1 Instrument Set Assembly Defect Recall

    Medacta Usa Inc recalls GMK Sphere CR Insert Instrument Set Size 1 due to component assembly error: Size 2 trial baseplates were assembled with Size 1 instrument sets, potentially affecting surgical function.

    Product
    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0800-2022·2022-03-23

    SAFE-T PLUS Adult Lumbar Puncture Tray recalled for manometer failure

    Bard Peripheral Vascular Inc recalled 3,240 SAFE-T PLUS Adult lumbar puncture trays due to manometer failures involving leaking and defective mating connections.

    Product
    SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0789-2022·2022-03-23

    SAM CHEST SEAL devices recalled due to assembly defect preventing wound seal

    Sam Medical Products is recalling 2,950 packages of SAM CHEST SEAL (Model CS203-EN, Lot Y060321-09) with defective dressing containing holes that prevent creating an occlusive seal for chest wounds.

    Product
    SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0799-2022·2022-03-23

    Lumbar Puncture Trays Recalled for Manometer Leaking and Assembly Defects

    Bard Peripheral Vascular Inc. is recalling 2,880 Lumbar Puncture Drug Free Trays due to defects in the manometer component involving leaking and mating issues that could affect device function.

    Product
    LUMBAR PUNCTURE DRUG FREE TRAY 22G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2022·2022-03-09

    K2M Everest MI XT Outer Dilators recalled for manufacturing defect

    K2M is recalling 686 Everest MI XT Outer Dilator units due to a manufacturing nonconformance that prevents them from fitting properly with inner dilators during surgical procedures.

    Product
    Everest MI XT Outer Dilator, Catalog Number 5101-90168
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2022·2022-02-09

    Spinal Fusion Implant Insert Recalled for Assembly Defect

    XTANT Medical is recalling 24 units of the X060-0270 8mm Titanium Insert for the Axle Interspinous Fusion System due to a manufacturing defect that prevents proper assembly of crossbar plates. The defect could affect the device's function during spinal fusion procedures.

    Product
    X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0346-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Capacitor Assembly Defect

    Covidien is recalling 278 Puritan Bennett 980 Series Ventilators (Model 980X1ENDIPC) due to incorrect capacitor assembly that may cause the device to malfunction during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0350-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recall Due to Assembly Defect

    Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to an assembly error where a capacitor was incorrectly installed, potentially causing the device to become inoperable during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1PLDIPC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0349-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator recalled for assembly defect

    Puritan Bennett 980 Series Ventilators are recalled due to a capacitor assembly error that may cause the device to become inoperable during use. The recall affects 278 units distributed worldwide.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1JADIJJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0353-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recall Due to Assembly Error

    Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators due to a capacitor assembly error that may cause the device to become inoperable during use. Affected devices were distributed worldwide with specific serial numbers targeted.

    Product
    Puritan Bennett 980 Series Ventilator, 980X3JADIJJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0343-2022·2021-12-15

    Puritan Bennett 980 Ventilator Recalled for Capacitor Assembly Error

    Covidien is recalling the Puritan Bennett 980 Series Ventilator due to incorrect capacitor assembly that may cause the device to become inoperable during patient use.

    Product
    Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2022·2021-10-20

    K2M Surgical Removal Tool Recalled for Missing Pins

    K2M, Inc. is recalling 23 units of the Chesapeake Anterior Lumbar Removal Tool because units may arrive with missing pins or in disassembled condition. Pins could dislodge during surgery and enter the surgical cavity, requiring intraoperative removal or revision surgery.

    Product
    Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
    Category
    Medical Device
    Distribution
    9 states