The Recall Desk

Hazard

Surgical Failure recalls

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

What the numbers show

Total
16
Critical
0
Severe
4
Most recent
2026-07-01

Of the 16 surgical failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (25%) 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 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.

1–16 of 16

  • HighFDA (Devices)·Z-2528-2026·2026-07-01

    Zimmer Shoulder Reamer Guide System Recalled for Plastic Breakage

    Zimmer is recalling Off-Axis Comprehensive Shoulder System reamer guides (Model 110040241) because plastic guides can catch and break during reaming. Five complaints have been received.

    Product
    Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1278-2024·2024-03-20

    D-Clip Applier Recalled for Failure to Release During Surgery

    Peter Lazic GmbH's D-Clip Standard/Mini Applier is being recalled after a customer complaint that the device failed to release the clip during surgery, with the applier remaining attached to the clip.

    Product
    D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0834-2024·2024-02-07

    Endoscopic Surgical Stapler Reload May Fail to Form Complete Staple Line

    An endoscopic surgical stapler reload may fail to properly form staples during use, potentially leaving tissue inadequately sealed. This could lead to bleeding or require additional surgery.

    Product
    ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1539-2023·2023-05-10

    Orthopedic knee implant system recalled due to early loosening risk

    Linkbio Corp. is recalling 5 units of the LINK SLED Knee System due to risk of early aseptic loosening or increased wear that could require earlier surgical revision. The recall addresses training and surgical technique to prevent implant failure.

    Product
    LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1228-2023·2023-03-15

    Tri-Staple 2.0 Surgical Stapler Reloads Recalled for Malfunction Risk

    Covidien is recalling certain Tri-Staple 2.0 surgical stapler reloads due to a mechanical defect that may cause the device to malfunction during surgery. Affected units may fail to form staples properly, potentially causing serious surgical complications.

    Product
    Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0739-2022·2022-03-16

    Nextra CH Hammertoe Surgical Implant Kit Recalled for Locking Mechanism Defect

    Nextremity Solutions recalls the Nextra CH Hammertoe Mini Instrument Kit for a defect that may deform the implant's locking mechanism during insertion, potentially requiring revision surgery.

    Product
    Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0448-2022·2022-01-12

    Orthopedic Inserter Shaft Recalled for Mating Incompatibility During Surgery

    Flower Orthopedics is recalling 48 units of the Flex-Thread Inserter Shaft due to mating incompatibility with the Inserter Draw Rod. The defect may cause the draw rod to bind during fibula intramedullary nail insertion, potentially preventing surgery completion.

    Product
    Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2036-2020·2020-05-27

    Applied Medical Recalls Stealth Spring Clips for Insufficient Vessel Occlusion

    Applied Medical Resources Corp is recalling 2,240 Stealth Spring Clips because they may fail to sufficiently occlude blood vessels during surgery.

    Product
    STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1277-2019·2019-05-22

    Ethicon Endo-Surgery Recalls Straight Intraluminal Staplers Due to Firing Defect

    Ethicon Endo-Surgery Inc is recalling 434,614 Straight Intraluminal Staplers (Model SDH29A) because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1274-2019·2019-05-22

    Ethicon Endo-Surgery Recalls 33 mm Endoscopic Curved Intraluminal Staplers

    Ethicon Endo-Surgery Inc is recalling 434,614 Model ECS33A staplers worldwide because they may have an insufficient firing stroke to break the washer and form staples.

    Product
    Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2131-2018·2018-06-13

    Orthofix Recalls MTP Plates Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling specific MTP plates because locking screws failed to properly engage during surgery.

    Product
    MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2132-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

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

    Product
    Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2126-2018·2018-06-13

    Orthofix Recalls Rival Fracture 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
    CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030)
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1945-2015·2015-07-08

    Biomet Gentle Threads Interference Screw Recall Due to Product Mix-Up

    Biomet is recalling Gentle Threads Interference Screws because two different part numbers were mixed. Using the incorrect screw may lead to failure or revision surgery.

    Product
    Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1944-2015·2015-07-08

    Biomet Recalls Gentle Threads Interference Screws Due to Lot Mixing

    Biomet is recalling 53 units of Gentle Threads Interference Screws because they were mixed with a different size, posing a risk of surgical failure.

    Product
    Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
    Category
    Medical Device
    Distribution
    0 states