The Recall Desk

Hazard

Mechanical Failure recalls

1,694 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,694
Critical
7
Severe
304
Most recent
2026-09-02

Of the 1,694 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 304 (18%) 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 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 1694

  • 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 (e.g
    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-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 produc
    Category
    Medical Device
    Distribution
    2 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-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-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 t
    Category
    Medical Device
    Distribution
    13 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
  • 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
  • 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 (002-E-2
    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-2127-2018·2018-06-13

    Orthofix Rival Plating System Recalled Due to Screw Engagement Failure

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

    Product
    Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006); b) 8MM Spacer (022-H-00008); c) 10MM Spacer (002-H-00010); d) 12MM Spacer (002-H-00012)
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2117-2018·2018-06-13

    Orthofix Rival View Kit Locking Screws Recalled for Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling Rival View Kit locking screws that failed to properly engage plates during surgery.

    Product
    Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2128-2018·2018-06-13

    Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure

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

    Product
    H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spacer (003-H-12001); b) 15MM Spacer (003-H-15001); 20MM Spacer (003-H-20001); 25MM Spacer (003-H-25001); 30 MM (003-H-30001)
    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
  • HighFDA (Devices)·Z-2116-2018·2018-06-13

    Orthofix Rival Reduce Kit Locking Screws Recalled for Failure to Engage Plates

    Orthofix is voluntarily recalling Rival Reduce Kit locking screws because they failed to properly engage plates during surgery.

    Product
    Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2129-2018·2018-06-13

    Orthofix Recalls Lapidus Plates Due to Screw Engagement Failure

    Orthofix is voluntarily recalling 156 Lapidus Plates because locking screws failed to properly engage the plates during surgery.

    Product
    Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-01000L); b) Small/0MM Step/Right (002-C-01000R); c) Large/0MM Step/Left (002-C-02000L); d) Large/0MM Step/Right (002-C-02000R); e) Small
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1953-2018·2018-06-06

    Genesee BioMedical Sternal Valve Retractors Recalled for Corrosion-Related Blade Failure

    Genesee BioMedical is recalling 444 Sternal Valve Retractors used in cardiac surgery due to corrosion that may cause the bearing or button to break.

    Product
    Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2018·2018-05-30

    Getinge Recalls ALM XTEN Surgical Lights Due to Broken Spring Arms

    Getinge is recalling 667 ALM XTEN Surgical Lights because spring arms may crack and break, causing light heads to separate.

    Product
    ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1824-2018·2018-05-23

    Medtronic Recalls Endo GIA Stapler Kits Due to Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA stapler kits worldwide because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" Devices Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1815-2018·2018-05-23

    Medtronic Recalls Endo GIA Stapler Loading Units Due to Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two,
    Category
    Medical Device
    Distribution
    Distributed nationwide