The Recall Desk

Hazard

Surgical Complication recalls

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

What the numbers show

Total
249
Critical
3
Severe
37
Most recent
2026-07-01

Of the 249 surgical complication recalls we have scored against our rubric, 3 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 37 (15%) 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 surgical complication 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.

126–150 of 249

  • HighFDA (Devices)·Z-2521-2018·2018-08-01

    DePuy CORAIL Femoral Stems Recalled Due to Incorrect Size Labeling

    DePuy Orthopaedics is recalling two lots of CORAIL femoral stems labeled as Size 11 but actually Size 12 due to fit and mechanical risks.

    Product
    CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
    Category
    Medical Device
    Distribution
    14 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 Cra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2381-2018·2018-07-18

    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 during surgery.

    Product
    da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2348-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Lead and Stylet Damage

    FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter can damage leads and stylets, potentially causing short circuits.

    Product
    microTargeting" Drive System, Product Number 66-ZD-MD-01
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2177-2018·2018-06-20

    Zimmer Biomet Recalls 75mm Tibial Tray Implants Due to Sizing Error

    Zimmer Biomet is recalling 16 units of 75mm tibial tray implants that may be incorrectly labeled as 79mm. This error could lead to surgical delays or the need for immediate revision surgery.

    Product
    Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2118-2018·2018-06-13

    Orthofix Recalls Rival Reduce Kit Plates Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling 50 units of Rival Reduce Kit Plates because locking screws failed to properly engage the plates during surgery.

    Product
    Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C
    Category
    Medical Device
    Distribution
    19 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-2125-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

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

    Product
    Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001); b) 22MM (003-F-22001); c) 30MM (003-F-30001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2135-2018·2018-06-13

    Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure

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

    Product
    Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
    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-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-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-2123-2018·2018-06-13

    Orthofix Recalls Non-Locking Screws Due to Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling specific Non-Locking Screws because they failed to properly engage plates during surgery.

    Product
    Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (002-D-32012) c) D 3.2MM X 14MM (002-D-32014) d) D 3.2MM X 16MM (002-D-32016) e) D 3.2MM X 18MM (002-D-32018) f) D 3.2MM X 20MM (002-D-32
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2119-2018·2018-06-13

    Orthofix Non-Locking Screws Recalled Due to Failure to Engage Plates

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

    Product
    Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010); c) D 2.0MM X 12MM (002-D-20012); d) D 2.0MM X 14MM (002-D-20014); e) D 2.0MM X 16MM (002-D-20016); f) D 2.0MM X 18MM
    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-2120-2018·2018-06-13

    Orthofix Locking Screws Recalled for Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they were confirmed to not properly engage plates during surgery.

    Product
    Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010); c) D 2.0MM X 12MM (002-E-20012); d) D 2.0MM X 14MM (002-E-20014); e) D 2.0MM X 16MM (002-E-20016); f) D 2.0
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2124-2018·2018-06-13

    Orthofix Locking Screws Recalled Due to 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 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012) c) D 3.2MM X 14MM (002-E-32014) d) D 3.2MM X 16MM (002-E-32016) e) D 3.2MM X 18MM (002-E-32018) f) D 3.2MM X 20MM (002-E-32020
    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-1240-2018·2018-04-04

    Zimmer Biomet Recalls Persona Partial Knee Spacer Blocks

    Zimmer Biomet is recalling Persona Partial Knee Spacer Blocks because they may feel tight during trialing or appear loose in extension.

    Product
    Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1258-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 92 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1257-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 92 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0672-2018·2018-02-28

    Ethicon Recalls Disposable Curved Circular Staplers Due to Malformed Staple Risk

    Ethicon Endo-Surgery Inc is recalling specific lots of disposable curved circular staplers because they may create staples that do not meet height specifications, resulting in malformed staples.

    Product
    Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0349-2018·2018-01-24

    Zimmer Biomet Recalls Persona Partial Knee Finishing Guides

    Zimmer Biomet is recalling 158 Persona Partial Knee System Size 8 Finishing Guides because they may not adequately account for shape differences, potentially causing additional surgery time or knee tightness.

    Product
    Persona Partial Knee System, Size 8, Finishing Guide
    Category
    Medical Device
    Distribution
    16 states