The Recall Desk

Hazard

Device Damage recalls

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

What the numbers show

Total
37
Critical
1
Severe
11
Most recent
2024-04-24

Of the 37 device damage recalls we have scored against our rubric, 1 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (30%) 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 device damage 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.

26–37 of 37

  • SevereFDA (Devices)·Z-2358-2018·2018-07-11

    FHC Depth Stop Adapter Recall Due to Lead Damage Risk

    FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring surgical replacement.

    Product
    microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2318-2017·2017-06-14

    Zimmer Biomet Recalls Vitality Spinal Fixation System Drivers

    Zimmer Biomet is recalling Vitality T27 Final Drivers and Torque Limiting Handles because they may create torsional springs that damage the device or cause torque values to go out of specification.

    Product
    Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2111-2017·2017-05-24

    Zimmer Werber Countersink Instruments Recalled Due to Material Defect

    Zimmer GmbH is recalling Werber Countersink instruments because raw material defects caused device damage.

    Product
    Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortic
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2900-2016·2016-10-05

    Beckman Coulter Recalls AQUIOS CL Flow Cytometers Due to Carousel Misalignment

    Beckman Coulter is recalling AQUIOS CL Flow Cytometers because the reagent carousel can misalign and damage the prep probe.

    Product
    AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2405-2015·2015-08-26

    Cordis RenLane Renal Denervation Catheter Recalled for Potential Tip Damage

    Cordis is recalling 98 RenLane Renal Denervation Catheters because the helical tip may be damaged if the arterial access device valve is not fully open.

    Product
    RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1758-2015·2015-06-17

    Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device Recalled for Potential Damage

    Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to potential damage near the hub that may cause blood leakage.

    Product
    Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0828-2015·2014-12-24

    Mako Surgical Recalls RESTORIS PST Straight Shell Impactors

    Mako Surgical Corporation is recalling 404 RESTORIS PST Straight Shell Impactors because they may be damaged during surgery.

    Product
    RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2014·2014-04-16

    Intuitive Surgical Recalls 5mm Curved Cannulae for da Vinci System

    Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System due to potential damage during use and to update labeling instructions.

    Product
    5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1333-2014·2014-04-16

    Intuitive Surgical Recalls 5mm Curved Cannulae for Potential Damage

    Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System because they may become damaged during use.

    Product
    5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1335-2014·2014-04-16

    Intuitive Surgical Recalls 5mm Curved Cannulae for da Vinci System

    Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System because they may become damaged during use. The recall also includes labeling updates to guide inspection and handling.

    Product
    5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1334-2014·2014-04-16

    Intuitive Surgical Recalls 5mm Curved Cannulae for da Vinci System

    Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System due to potential damage during use and to update labeling instructions.

    Product
    5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1190-2013·2013-05-08

    Medtronic Recalls Deep Brain Stimulation Lead Kits Due to Damage Risk

    Medtronic is recalling 30,000 Deep Brain Stimulation lead kits worldwide because the provided lead cap may damage the lead connector during use.

    Product
    Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for Dyston
    Category
    Medical Device
    Distribution
    Distributed nationwide