The Recall Desk

Hazard

Mechanical Defect recalls

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

What the numbers show

Total
283
Critical
2
Severe
11
Most recent
2026-07-22

Of the 283 mechanical defect recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (4%) 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 mechanical 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.

201–225 of 283

  • HighFDA (Devices)·Z-2781-2015·2015-09-23

    Salter Labs NebuTech Nebulizers Recalled for Loose Inspiratory Valve Cap

    Salter Labs is recalling specific NebuTech nebulizer models because the inspiratory valve cap may detach during treatment.

    Product
    NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2778-2015·2015-09-23

    Fujifilm Medical Endoscope Manuals Recalled Due to Suction Button Defect

    Fujifilm Medical Systems U.S.A., Inc. is recalling 256 endoscope operation manuals because the suction button may become stuck after using x-ray contrast agents.

    Product
    Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2464-2015·2015-09-02

    Trilliant Surgical Recalls Tiger Cannulated Screw System Tray Lids

    Trilliant Surgical Ltd. is recalling 71 units of Tiger Cannulated Tray Lids because they are occasionally difficult to remove from sterilization trays.

    Product
    Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the Tig
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2015·2015-06-17

    Edwards Lifesciences Recalls ClearSight Heart Reference Sensor Due to Damage

    Edwards Lifesciences is recalling ClearSight Heart Reference Sensors because the finger component may be damaged. The recall affects 1,309 units distributed worldwide.

    Product
    ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1659-2015·2015-06-03

    Siemens Recalls Liquid Waste Bottles for Immulite 2000 Systems

    Siemens Medical Solutions Diagnostics is recalling 231 Liquid Waste Bottles for Immulite 2000 systems due to a quality issue where the opening may be undersized or deformed, preventing the cap from closing securely.

    Product
    Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1660-2015·2015-06-03

    Siemens Immulite 2000 Accessory Kit Recall for Undersized Bottle Openings

    Siemens Medical Solutions Diagnostics is recalling Immulite 2000 Accessory Kits because bottle openings may be undersized or deformed, preventing caps from closing securely.

    Product
    Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1600-2015·2015-05-20

    Synthes Recalls TFNA Proximal Femoral Nails Due to Locking Mechanism Defect

    Synthes, Inc. is recalling 8,175 TFNA Proximal Femoral Nails because the locking mechanism was assembled too close to the top, potentially causing surgical delays.

    Product
    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2015·2015-04-01

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Joint Sensor Fault

    Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide due to a fault causing distal sensor failures and position mismatches.

    Product
    da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1297-2015·2015-03-25

    Siemens E.CAM Systems Recalled for Incorrectly Assembled Radial Motor Drives

    Siemens Medical Solutions is recalling E.CAM emission computed tomography systems because radial motor drives replaced during service were assembled backwards.

    Product
    E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1296-2015·2015-03-25

    Siemens Symbia E SPECT Systems Recalled for Incorrect Radial Motor Assembly

    Siemens Medical Solutions is recalling 419 Symbia E SPECT systems worldwide because radial motor drives were incorrectly assembled backwards during a customer service action.

    Product
    Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1141-2015·2015-03-04

    Intuitive Surgical Recalls EndoWrist Vessel Sealers Due to Grip Interference

    Intuitive Surgical is recalling 3,282 EndoWrist One Vessel Sealers because manufacturing variability may cause interference in the instrument grips.

    Product
    EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1142-2015·2015-03-04

    Intuitive Surgical Recalls EndoWrist Vessel Sealers Due to Grip Interference

    Intuitive Surgical is recalling EndoWrist One Vessel Sealers because manufacturing variability may cause interference in the instrument grips.

    Product
    EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2015·2015-02-25

    Nidek MC-500 Laser Photocoagulator Recalled for Spot Size Control Defect

    Nidek Inc is recalling 16 MC-500 Multicolor Laser Photocoagulators because the spot size control may turn by itself, posing a risk of unintended laser delivery.

    Product
    MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2015·2015-01-21

    Biomet Timberline Anchored Lateral Variable Retractable Sleeves Recalled for Undersized Diameter

    Biomet Spine is recalling 12 units of Timberline Anchored Lateral Variable Retractable Sleeves because the inner diameter is undersized, causing interference fit issues.

    Product
    Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized t
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0982-2015·2015-01-21

    Biomet Spine Recalls Anchored Lateral Retractable Drills Due to Sizing Defect

    Biomet Spine is recalling 15 Anchored Lateral Retractable Drills because the shaft diameter is oversized, causing interference when inserted into sleeve assemblies.

    Product
    Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0983-2015·2015-01-21

    Biomet Spine Recalls Timberline Anchored Lateral Fixed Retractable Sleeves

    Biomet Spine is recalling 14 Timberline Anchored Lateral Fixed Retractable Sleeves because the inner diameter is undersized, causing interference fit when inserting instruments.

    Product
    Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae. The T
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0859-2015·2014-12-31

    Siemens ADVIA Centaur Laboratory Analyzer Recall for Tubing Crack Risk

    Siemens is recalling ADVIA Centaur laboratory analyzers because a slight crack in the tubing at the reservoir connector may occur due to mechanical stress.

    Product
    ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0860-2015·2014-12-31

    Siemens ADVIA Centaur XP Immunoassay System Recalled for Tubing Crack Risk

    Siemens Healthcare Diagnostics is recalling 10,515 ADVIA Centaur XP Immunoassay Systems because a slight crack may occur in the tubing at the reservoir connector assembly due to mechanical stress.

    Product
    ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0144-2015·2014-11-05

    IMRIS Operating Room Table Recalled Due to Missing Alignment Pin

    IMRIS Inc is recalling 14 ORT200 and ORT300 operating room tables because a pin holding the alignment block in place went missing during testing.

    Product
    IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0152-2015·2014-11-05

    Elekta Recalls Laksell Gamma Knife Perfexion Units Due to Latch Defect

    Elekta is recalling 181 Laksell Gamma Knife Perfexion units because latches may lock before being fully turned, resulting in a poorly locked frame.

    Product
    Laksell Gamma Knife Perfexion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0080-2015·2014-10-22

    Baxter 15 L Cycler Drainage Bag Recalled for Potential Drain Tube Leakage

    Baxter Healthcare is recalling 15 L Cycler Drainage Bags because the tube clamp may not fully close, potentially causing leakage.

    Product
    15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2537-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-2539-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • ModerateFDA (Devices)·Z-2543-2014·2014-09-03

    Zimmer Persona Distal Valgus Alignment Guide Recalled for Mechanical Defect

    Zimmer, Inc. is recalling 2,248 units of the Persona Distal Valgus Alignment Guide because the collet locks are seizing in the unlocked position.

    Product
    Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2538-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty in locking the holder or passing a suction catheter.

    Product
    H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states