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.

76–100 of 283

  • HighFDA (Devices)·Z-2546-2020·2020-07-15

    Cook Zenith Alpha Abdominal Endovascular Graft Recall for Damaged Bushing

    Cook Inc. is recalling 571 units of Zenith Alpha Abdominal Endovascular Grafts due to a potential damaged bushing that may prevent full deployment.

    Product
    Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2543-2020·2020-07-15

    Cardinal Health NPWT Canisters Recalled for Oversized O-Ring Defect

    Cardinal Health is recalling 3,000 NPWT Canisters with Gel 300cc because they may contain an oversized O-ring that cannot be installed.

    Product
    Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Car
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2292-2020·2020-06-17

    Olympus ENF-GP2 Fiberscope Recalled for Missing O Ring

    Olympus is recalling 19 ENF-GP2 Rhino-Laryngo Fiberscopes because they may be missing an O ring after being repaired with an incorrect service manual.

    Product
    ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2020·2020-06-03

    Argon Skater Introducer Set Recalled Due to Detaching Tungsten Coils

    Argon Medical Devices is recalling Skater Introducer Sets because tungsten coils on the guidewire may detach. The recall affects 15,795 units distributed in China and Taiwan.

    Product
    Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for cathet
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1922-2020·2020-05-13

    Philips Brilliance iCT SP CT Scanner Recall Due to Bolt Issue

    Philips is recalling two Brilliance iCT SP CT scanners because a cooling unit bolt was not tightened to specification.

    Product
    Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0845-2020·2020-02-05

    Intuitive da Vinci SP Surgical System Cannula Mount Button Recall

    Intuitive Surgical is recalling five da Vinci SP surgical systems because the cannula mount button may be damaged if released abruptly.

    Product
    The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port (c
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0658-2020·2019-12-18

    Medtronic Biopsy Needle FPU Kit Recalled for Depth Stop Issue

    Medtronic Navigation is recalling Biopsy Needle FPU Kits because the depth stop may not tighten securely, potentially delaying surgery.

    Product
    Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
    Category
    Medical Device
    Distribution
    49 states
  • CriticalFDA (Devices)·Z-0541-2020·2019-12-11

    GE Healthcare Recalls Giraffe Infant Warmers Due to Latching Defect

    GE Healthcare is recalling Giraffe infant warmers because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.

    Product
    Giraffe Incubator infant warmer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0540-2020·2019-12-11

    GE Healthcare Recalls Giraffe Incubator Carestations Due to Latch Defect

    GE Healthcare is recalling Giraffe Incubator Carestations because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.

    Product
    Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0539-2020·2019-12-11

    GE Healthcare Recalls Giraffe OmniBed Carestations Due to Latching Defect

    GE Healthcare is recalling Giraffe OmniBed Carestations because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.

    Product
    Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0416-2020·2019-11-27

    Guardia Access Embryo Transfer Catheter Recall Due to Bent Tips

    The FDA is recalling the Guardia Access Embryo Transfer Catheter because bent tips can make insertion difficult, potentially requiring repeat procedures. No injuries have been reported, so the recall is classified as moderate severity.

    Product
    Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0352-2020·2019-11-20

    Smiths Medical Recalls ProtectIV Plus Safety IV Catheters

    Smiths Medical is recalling certain lots of ProtectIV Plus Safety IV Catheters because the safety mechanism guard may be damaged.

    Product
    ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Drugs)·D-0156-2020·2019-11-06

    Glenmark Recalls Estradiol Vaginal Inserts Due to Applicator Defect

    Glenmark Pharmaceuticals is recalling Estradiol Vaginal Inserts because the applicator plunger may be difficult to push.

    Product
    ESTRADIOL VAGINAL INSERTS — ESTRADIOL VAGINAL INSERTS (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0123-2020·2019-10-23

    Medtronic Solarice Balloon Catheter Recall Due to Stylette Removal Difficulty

    Medtronic is recalling Solarice Rapid Exchange Balloon Dilatation Catheters because a slightly higher diameter stylette may cause removal difficulties.

    Product
    Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC25
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0028-2020·2019-10-09

    Voco Grandio SO Heavy Flow Caps Recalled for Loose Cannula

    Voco GmbH is recalling Grandio SO Heavy Flow Caps because the metal cannula may be too loose and detach during use.

    Product
    Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2499-2019·2019-09-18

    Exactech Recalls Threaded Offset Cup Impactor Due to Gritty Mechanism

    Exactech, Inc. is recalling 22 Threaded Offset Cup Impactors because the threaded mechanism may be gritty and difficult to turn, potentially due to entrapped blast media.

    Product
    Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2342-2019·2019-08-28

    Siemens MAGNETOM Aera MRI Devices Recalled for Quench Venting System Port Issue

    Siemens Medical Solutions USA is recalling 143 MAGNETOM Aera MRI devices due to a potential open port in the quench venting system when using the optional horizontal outlet.

    Product
    MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-2081-2019·2019-07-31

    GammaPod Stereotactic Radiotherapy System Recalled for Alignment Drift

    Xcision Medical Systems is recalling two GammaPod Stereotactic Radiotherapy Systems because a loose bolt caused alignment drift and reduced radiation dose output.

    Product
    GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treat
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1929-2019·2019-07-10

    Philips Recalls Vereos PET/CT Systems Due to Cover Misalignment

    Philips Medical Systems is recalling 70 Vereos PET/CT systems because misaligned covers may create gaps or protrude into the imaging bore.

    Product
    Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1928-2019·2019-07-10

    Roche cobas p 701 Post-Analytical Units Recalled for Loose Flap

    Roche Diagnostics is recalling nine cobas p 701 post-analytical units because the tray input flap may become loose and detach.

    Product
    cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1823-2019·2019-06-26

    Mako Surgical Recalls 2.7 Degree Angled Sagittal Saw Attachments

    Mako Surgical Corporation is recalling 39 units of the 2.7 Degree Angled Sagittal Saw attachment because the bearings were ungreased.

    Product
    2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1709-2019·2019-06-12

    Abbott Recalls Alinity c Cuvette Segments Due to Seating Defect

    Abbott is recalling Alinity c Cuvette Segments because individual cuvettes may seat lower than designed, potentially preventing the sample probe from making efficient contact with the cuvette bottom.

    Product
    Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and auto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1411-2019·2019-05-29

    Oakworks Lithotripsy Table Recalled for Incorrect Actuator Assembly Error

    Oakworks Inc. is recalling three Lithotripsy/Urology Tables due to an assembly error involving incorrect actuators for lateral and longitudinal movements.

    Product
    OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic
    Category
    Medical Device
    Distribution
    Distributed nationwide