The Recall Desk

Hazard

Surgical Error recalls

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

What the numbers show

Total
58
Critical
0
Severe
3
Most recent
2025-04-30

Of the 58 surgical error recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (5%) 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 error 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.

1–25 of 58

  • HighFDA (Devices)·Z-1651-2025·2025-04-30

    Stryker Latitude EV Humeral Revision Stem Trial with Incorrect Marking

    A specific lot of Stryker Latitude Humeral Trial Stems has incorrect laser marking and color indicator, potentially resulting in implantation of the wrong device size and orientation.

    Product
    stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1499-2021·2021-05-05

    ConMed Infinity ACL Tibial Guides Recalled for Potential Misalignment

    ConMed Corporation is recalling three Infinity ACL Tibial Elbow and Tip Guides due to potential lateral misalignment that could affect surgical accuracy.

    Product
    KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction The procedural kits have no kit specific labeling. Each produc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1131-2021·2021-02-24

    Biomet Recalls Mislabelled 25mm Shoulder Prosthesis Central Screws

    Biomet is recalling 49 units of 25mm central screws for shoulder prostheses because they were mislabeled as 25mm but are actually 40mm.

    Product
    Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2021·2021-01-13

    Medline Recalls Non-X-Ray Detectable Surgical Sponges in Convenience Kits

    Medline Industries is recalling 88 surgical convenience kits because the cylindrical sponge component is not x-ray detectable. The affected products were distributed only in Canada.

    Product
    Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0781-2021·2021-01-13

    Medline Thyroid Pack Recall Due to Non-X-Ray Detectable Sponge

    Medline Industries is recalling 40 Thyroid Pack CKHA-LF kits because the cylindrical sponge component is not x-ray detectable. The affected units were distributed only to Canada.

    Product
    Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0780-2021·2021-01-13

    Medline Simple Neck Dissection Kit Recalled for Non-X-Ray Detectable Sponge

    Medline Industries is recalling 90 units of Simple Neck Dissection kits because the cylindrical sponge component is not x-ray detectable.

    Product
    Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0472-2021·2020-11-25

    Mako MICS Handpiece Recalled for Potential Bone Preparation Discrepancies

    Stryker is recalling Mako MICS Handpieces due to a characterization issue that may cause unsuccessful checkpoint verification or bone cuts differing from the preoperative plan.

    Product
    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to ex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2745-2020·2020-08-12

    Mako Hip End Effector Recalled for Potential Bone Preparation Discrepancy

    Mako Surgical Corporation is recalling 12 units of Mako Hip End Effectors due to a characterization issue that may cause discrepancies during bone preparation in certain Mako Total Hip procedures.

    Product
    Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1995-2020·2020-05-27

    Medtronic Nexframe Stereotactic System Recalled for Lead Placement Inaccuracies

    Medtronic is recalling the Nexframe Stereotactic System and specific software combinations due to potential inaccuracies in deep brain stimulation lead placement.

    Product
    Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2020·2020-04-29

    Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak Recall

    Alcon Research LLC is recalling 102 sterile procedure packs due to a potential mix-up with a 25-gauge infusion cannula.

    Product
    Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1559-2020·2020-04-01

    Intellijoint Navigation System Software Recalled for Incorrect Knee Surgery Calculations

    Intellijoint Surgical is recalling its Navigation System software because it may incorrectly calculate femur resection depth during total knee arthroplasty.

    Product
    Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2020·2020-04-01

    Biomet Recalls Misidentified 9mm Shoulder Mini Humeral Stem Implants

    Biomet is recalling 14 units of 9mm Shoulder Mini Humeral Stems that were misidentified as 15mm units. The error poses a risk of improper surgical implantation.

    Product
    Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0595-2020·2019-12-11

    Zimmer Biomet Recalls Intramedullary Bone Saw Cam Assemblies Due to Sizing Error

    Zimmer Biomet is recalling 34 units of 14MM Intramedullary Bone Saw Cam Assemblies because some were labeled as 14MM but measured as 13MM.

    Product
    Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0594-2020·2019-12-11

    Zimmer Biomet Recalls 13MM Intramedullary Bone Saw Cam Assemblies

    Zimmer Biomet is recalling 26 units of 13MM Intramedullary Bone Saw Cam Assemblies due to possible commingling with 14MM units.

    Product
    Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1880-2019·2019-07-03

    Medtronic Mosaic 310 Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Mosaic 310 Bioprosthesis mitral valves because they were mislabeled with incorrect sizes. The actual valves are larger than indicated on the packaging.

    Product
    Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1082-2019·2019-04-24

    Brainlab Spine & Trauma 3D Navigation Software Recall for Display Error

    Brainlab AG is recalling Spine & Trauma 3D Navigation 1.0 software because it may display fixed image planes instead of the desired inline view, potentially preventing surgeons from determining instrument position.

    Product
    Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2019·2019-04-10

    Zimmer Biomet Recalls RingLoc Hip System Bone Screws Due to Packaging Error

    Zimmer Biomet is recalling 809 units of RingLoc Hip System Self-Tapping Bone Screws because 30mm screws may have been packaged as 20mm screws, and vice versa.

    Product
    Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2877-2018·2018-08-29

    TriMed Ulnar Osteotomy Compression Plate Recalled for Manufacturing Defect

    TriMed Inc. is recalling 722 Ulnar Osteotomy Compression Plates because instrument holes are located on the wrong side of the plate.

    Product
    Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1938-2018·2018-06-06

    Ad-Tech Medical Recalls Disposable Drill Kits Due to Potential Component Mix-Up

    Ad-Tech Medical Instrument Corporation is recalling 30 sterile Disposable Drill Kits because they may contain drill bits from the wrong catalog number.

    Product
    Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a ste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1259-2018·2018-04-04

    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 50mm, REF 804-07-500 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-0591-2018·2018-02-21

    Aesculap Vega Knee Trial Plateau Recalled for Incorrect Labeling

    Aesculap is recalling 13 units of the NS357R Vega PS Tibia Trial/Preparation Plateau size T4 due to incorrect labeling. Using the wrong size could lead to implantation errors, ligament injury, pain, or revision surgery.

    Product
    NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2018·2018-02-21

    Zimmer Biomet Recalls G7 Dual Mobility Hip Liners Due to Labeling Error

    Zimmer Biomet is recalling 8 units of G7 Dual Mobility Liners because they are labeled as 44mm but may physically be 42mm liners.

    Product
    G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2018·2018-02-07

    MicroAire Recalls Sterile Twist Drills Due to Incorrect Size Inclusion

    MicroAire Surgical Instruments is recalling 42 sterile twist drills because one lot contained an incorrect 2.0mm drill alongside the correct 1.6mm drill.

    Product
    SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0239-2018·2017-12-20

    FDA Recalls Piranha Cervical Spine Screws Due to Incorrect Length Marking

    The FDA is recalling 82 Piranha screws used in cervical spine surgery because some units marked as 12 mm actually measure 14 mm.

    Product
    Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical P
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-3057-2017·2017-08-30

    Medtronic AxiEM ENT Suction Kits Recalled for Verification Failure

    Medtronic is recalling eight AxiEM ENT suction kits because the instruments fail mandatory pre-use verification tests.

    Product
    Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used
    Category
    Medical Device
    Distribution
    Distributed nationwide