The Recall Desk

Hazard

Mechanical Failure recalls

1,704 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,704
Critical
7
Severe
366
Most recent
2026-10-22

Of the 1,704 mechanical failure recalls we have scored against our rubric, 7 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 366 (21%) are Severe.

About this hazard tag

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

726–750 of 1704

  • HighFDA (Devices)·Z-2592-2018·2018-08-08

    Integra LifeSciences Recalls Mayfield Infinity XR2 Base Units

    Integra LifeSciences is recalling 409 Mayfield Infinity XR2 Base Units because the knob assembly in the swivel adapter may fracture or break during use.

    Product
    MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2597-2018·2018-08-08

    Baxter Recalls Power Cords for AMIA Automated PD Cycler

    Baxter Healthcare is recalling power cords for the AMIA Automated PD Cycler because the socket may detach when unplugged.

    Product
    power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2517-2018·2018-08-01

    Implantcast Recalls Hip Implant Inserts Due to Retaining Ring Mounting Risk

    Implantcast GmbH is recalling specific 2M insert 15degree orthopedic hip implant components because the retaining ring may be incorrectly mounted.

    Product
    2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number 02424244 Size 44/48 mm REF number 02424448 Size 46/52 mm REF number 02424652
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2539-2018·2018-08-01

    Ad-Tech Drill Sleeve Guides Recalled Due to Raw Material Tolerance Defect

    Ad-Tech Medical Instrument Corporation is recalling 65 Drill Sleeve Guides because raw material diameter was under tolerance, which could cause drill bits to seize during surgery.

    Product
    AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2527-2018·2018-08-01

    GE MR Surgical Suite Option Recalled for Patient Transfer Mechanism Defect

    GE Medical Systems is recalling 54 MR Surgical Suite Option units because a defect in the table transfer release may cause an unexpected loss of function in the patient transfer mechanism.

    Product
    MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution high signal-to-noise…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2555-2018·2018-08-01

    Leica M320 Microscope Systems Recalled for Gas Spring Bracket Failure

    Leica Microsystems is recalling 8,564 M320 Microscope Systems because screws holding the gas spring bracket may fail, causing the optics carrier to drop.

    Product
    Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 Product Usage: Intended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2508-2018·2018-07-25

    Medtronic Tri-Staple 2.0 Intelligent Reloads Recalled for Missing Sled Component

    Medtronic is recalling Tri-Staple 2.0 Intelligent Reloads because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30AVM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2511-2018·2018-07-25

    Medtronic Endo GIA Stapler Recall Due to Missing Sled Component

    Medtronic is recalling Endo GIA staplers that may be missing a sled component, which could cause staple line failure, bleeding, or leakage during surgery.

    Product
    Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA454AVM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2434-2018·2018-07-25

    AesDex Cardica C-Port Flex-A PLUS Distal Anastomosis System Recalled for Handle Damage

    AesDex is recalling the Cardica C-Port Flex-A PLUS Distal Anastomosis System because the handle mechanism may be damaged during use, potentially causing plastic fragments to disperse.

    Product
    AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel and conduit. The stainless steel clips…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2380-2018·2018-07-18

    Intuitive Surgical Recalls da Vinci Xi Stapler Reloads Due to Missing Component

    Intuitive Surgical is recalling da Vinci Xi Stapler 45 Reloads because a missing knife mechanism component may prevent the device from cutting tissue.

    Product
    da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2411-2018·2018-07-18

    Fort Defiance P2131 Steam Sterilizer Recalled for Plumbing Deposits

    Fort Defiance Industries is recalling 199 P2131 Automated Field Steam Sterilizers because stagnant water and metal interactions can create deposits that interfere with the rear sight gauge or water liquid level switch.

    Product
    FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2301-2018·2018-07-04

    Philips OmniDiagnost X-ray System Recalled for Tilt Actuator Failure Risk

    Philips is recalling 477 OmniDiagnost Classic X-ray systems because a broken tilt actuator could cause the table to rotate uncontrollably, posing a risk of injury.

    Product
    OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2283-2018·2018-07-04

    Siemens ARTIS Pheno X-Ray System Recalled for C-Arm Drop Hazard

    Siemens is recalling 39 ARTIS Pheno Interventional Fluoroscopic X-Ray Systems because the C-arm may drop up to 20 mm, potentially injuring patients.

    Product
    ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2157-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 2 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2136-2018·2018-06-20

    Roche cobas e 801 Immunoassay Analyzer Recalled for Plunger Defect

    Roche Diagnostics is recalling 35 cobas e 801 immunoassay analyzers because a tilted syringe plunger may crack, leading to impaired syringe function.

    Product
    cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2150-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Retaining Ring Defect

    Sun Med, LLC is recalling 40 cases of Medline Adult Manual Resuscitators because a retaining ring may not seat fully, allowing the patient port to detach and impact air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2179-2018·2018-06-20

    Datascope Recalls Pediatric Cardiopulmonary Bypass Tubing Kits Due to Valve Defect

    Datascope Corporation is recalling 27 pediatric cardiopulmonary bypass tubing kits because the over-pressure safety valve may fail to allow flow.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2147-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Potential Port Detachment

    Sun Med, LLC is recalling 60 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1116F
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2160-2018·2018-06-20

    Maquet Aortic Arterial Cannula Recall Due to De-airing Plug Defect

    Maquet is recalling Aortic Arterial Cannulas because de-airing plugs may break during removal. The defect could compromise the device's integrity during cardiopulmonary bypass.

    Product
    Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2122-2018·2018-06-13

    Orthofix Locking Screws Recalled for Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling specific locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they failed to properly engage plates during surgery.

    Product
    Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (002-E-27010); c) D 2.7MM X 12MM (002-E-27012); d) D 2.7MM X 14MM (002-E-27014); e) D 2.7MM X 16MM (002-E-27016); f) D 2.7MM X 18MM…
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2130-2018·2018-06-13

    Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2133-2018·2018-06-13

    Orthofix Recalls TN Plates Due to Screw Engagement Failure

    Orthofix is voluntarily recalling TN Plates because locking screws failed to properly engage the plates during surgery.

    Product
    TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025); c) Large (002-F-01030)
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2063-2018·2018-06-13

    Orthofix Recalls TL-HEX TruLok Hexapod System Due to Incompatibility

    Orthofix Srl is recalling 408 units of TL-HEX TruLok Hexapod System double row footplates because they are incompatible with current struts, posing a risk of dimensional interference.

    Product
    TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system.…
    Category
    Medical Device
    Distribution
    1 state