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.

151–175 of 249

  • HighFDA (Devices)·Z-2871-2017·2017-08-16

    Sorin Group Aortic Arch Cannula Recalled for Excess Plastic on Tip

    Sorin Group USA, Inc. is recalling Aortic Arch Cannulas due to the identification of excess plastic on the tip of the device.

    Product
    Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2869-2017·2017-08-09

    In2Bones Recalls Non-Locking Orthopedic Screws Due to Perioperative Breakage

    In2Bones, SAS is recalling specific non-locking orthopedic screws after customer complaints reported breakage during insertion into the radius bone.

    Product
    Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 (f) NEO(R) 0.27 - 18 mm, REF W27 ST01
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2098-2017·2017-05-24

    Bausch & Lomb Recalls SoftPort Easy-Load Lens Delivery System

    Bausch & Lomb is recalling specific lots of the SoftPort Easy-Load Lens Delivery System due to reports of kinked haptics during lens delivery.

    Product
    SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic pull
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1483-2017·2017-03-22

    Acumed Orthopedic Guide Wires Recalled Due to Packaging Errors

    Acumed LLC is recalling specific lots of .045 and .054 orthopedic guide wires because they were mis-packaged with incorrect size labels.

    Product
    .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1399-2017·2017-03-15

    Parker Medical Recalls Left Double Lumen Endobronchial Tubes

    Parker Medical is recalling specific lots of Left Double Lumen Endobronchial Tubes because the single lung isolation feature did not function as intended.

    Product
    Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0759-2017·2016-12-21

    Telefac Medical Recalls Weck Facial Closure Systems Due to Detachment Risk

    Teleflex Medical is recalling 2,265 units of Weck Facial Closure Systems because the device wings may partially detach from the shield during use.

    Product
    Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0766-2017·2016-12-21

    Encore Medical Recalls Empowr PS Knee System Box Cut Guides

    Encore Medical is recalling 162 Empowr PS Knee System Box Cut Guides because femoral chipping occurred during surgery.

    Product
    Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0316-2017·2016-11-02

    Aesculap Safil Suture Recall Due to Needle Detachment Risk

    Aesculap is recalling 180 units of Safil QUI + UNDY 5/0 sutures because the needle may detach from the thread during surgery.

    Product
    Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0125-2017·2016-10-26

    X Spine Systems Recalls Calix P PEEK Lumbar System Trial Devices

    X Spine Systems is recalling 1,504 Calix P PEEK Lumbar System trial devices because parts may detach and lodge in the surgical site.

    Product
    Calix P PEEK Lumbar System, PLIF Trial
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1836-2016·2016-06-08

    Intuitive Surgical Recalls da Vinci Xi Cannula Seals Due to Particulate Risk

    Intuitive Surgical is recalling da Vinci Xi cannula seals because particulates may enter the cannula lumen during surgery, potentially affecting patients.

    Product
    SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when th
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1688-2016·2016-05-25

    Alcon Recalls LenSx Lasers Due to Incomplete Corneal Flap Creation

    Alcon is voluntarily recalling 81 LenSx Laser Systems with Corneal Flap Capability due to reports of incomplete corneal flap creation during surgery.

    Product
    LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1551-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation

    Smith & Nephew is recalling 6 units of TC-PLUS tibial knee prostheses due to a dimensional deviation that may prevent the polyethylene insert from seating correctly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1545-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Tibial Knee Components Due to Dimensional Deviation

    Smith & Nephew is recalling 22 units of TC-Plus tibial knee components distributed in Germany and Switzerland due to a dimensional deviation that may prevent proper seating of the polyethylene insert.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1547-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Tibial Knee Prosthesis Components

    Smith & Nephew is recalling 33 units of TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating of the polyethylene insert during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 024, S&N 7500279, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1550-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Knee Prosthesis Due to Dimensional Deviation

    Smith & Nephew is recalling specific TC-Plus knee prostheses distributed in Germany and Switzerland because a dimensional deviation may prevent the polyethylene insert from seating correctly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 027, S&N 7500282, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1541-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components

    Smith & Nephew is recalling four units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N 7500266, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1537-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation

    Smith & Nephew is recalling two units of the TC-PLUS Primary Fixed Tibial Component due to a dimensional deviation that may prevent the polyethylene insert from seating properly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1548-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Knee Prosthesis Components

    Smith & Nephew is recalling 33 units of TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent proper assembly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 025, S&N 7500280, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1544-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components

    Smith & Nephew is recalling 24 units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1539-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Tibial Knee Prosthesis Components

    Smith & Nephew is recalling three TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating of the polyethylene insert during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1546-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Knee Prosthesis Due to Dimensional Deviation

    Smith & Nephew is recalling 15 units of TC-PLUS Primary Fixed Tibial Components due to a dimensional deviation that may prevent proper seating of the polyethylene insert.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 7500274, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1540-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Knee Prosthesis Due to Dimensional Deviation

    Smith & Nephew is recalling one unit of a TC-Plus knee prosthesis due to a dimensional deviation that may prevent the polyethylene insert from seating correctly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N 7500264, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1538-2016·2016-04-27

    Smith & Nephew Recalls TC-PLUS Tibial Knee Prosthesis Components

    Smith & Nephew is recalling six units of TC-PLUS tibial knee prosthesis components due to a dimensional deviation that may prevent the polyethylene insert from seating correctly during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1543-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components

    Smith & Nephew is recalling 6 units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating of the polyethylene insert during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N 7500268, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1549-2016·2016-04-27

    Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components

    Smith & Nephew is recalling 34 units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating during surgery.

    Product
    TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N 7500281, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
    Category
    Medical Device
    Distribution
    0 states