Hazard

Surgical Injury recalls

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

What the numbers show

Total: 90
Critical: 0
Severe: 45
Most recent: 2024-03-20

Of the 90 surgical injury recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (50%) 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 injury 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.

76–90 of 90

SevereFDA (Devices)·Z-0026-2013·2012-10-17
OrthoHelix 3.2mm Cannulated Hex Driver Recall Due to Tip Breakage
Orthohelix Surgical Designs Inc is recalling 47 non-sterile 3.2mm cannulated hex drivers because their tips are breaking while driving screws into patients.
Product
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the h
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0036-2013·2012-10-17
Medtronic Atlantis Anterior Cervical Plate Screw Module Recalled for Measurement Error
Medtronic is recalling the Atlantis Anterior Cervical Plate System Variable Angle Screw Module because gauge lines may be misaligned, leading to inaccurate screw length measurements.
Product
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring func
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2437-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 268,022 units of the Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric su
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2434-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 4,867 units of the Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET4548. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2438-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 15,936 units of the Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET6048. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2436-2012·2012-10-03
FDA Recalls Covidien Duet TRS Staplers Due to Injury Risk
The FDA is recalling 22,218 units of the Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2433-2012·2012-10-03
FDA Recalls Covidien Duet TRS Surgical Staplers Due to Injury Risk
The FDA is recalling 94,301 units of the Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric su
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2432-2012·2012-10-03
FDA Recalls Covidien Duet TRS Staplers Due to Injury Risk
The FDA is recalling 433,528 units of the Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surger
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2435-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 104,355 units of the Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric su
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2439-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 135,712 units of the Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric su
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2165-2012·2012-08-15
Smith & Nephew TWINFIX Ultra Ti Suture Anchor Recall for Breakage Risk
Smith & Nephew is recalling 913 units of TWINFIX Ultra Ti Suture Anchors because the distal part may break during insertion into bone.
Product
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2091-2012·2012-08-08
Zimmer Recalls Nextgen Knee Instruments Due to Spring Clip Fracture Risk
Zimmer Inc. is recalling 1,662 Nextgen Complete Knee Solution Femoral and Provisional Impactor/Extractor instruments because the spring clip may fracture or fall off during use, potentially leaving fragments in the surgical site.
Product
Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1980-2012·2012-07-18
Zimmer Recalls Pathfinder NXT Fixed Percutaneous Rod Holder Due to Cracking
Zimmer, Inc. is recalling Pathfinder NXT Fixed Percutaneous Rod Holders because the tip may crack or break during surgery.
Product
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: The rod is held by the instrument for inserting and guiding into the screw heads via percutaneous delivery during minimal
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1981-2012·2012-07-18
Zimmer Recalls Pathfinder NXT Fixed Percutaneous Rod Holder Due to Cracking
Zimmer, Inc. is recalling the Pathfinder NXT Fixed Percutaneous Rod Holder because the tip may crack or break during surgery.
Product
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: PathFinder NXT is a minimally invasive pedicle screw system. The PathFinder NXT System consists of various screws and ro
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1938-2012·2012-07-11
DePuy Spine Side Fire Needles Recalled for Breakage Reports
DePuy Mitek is recalling 704 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage.
Product
Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on
Category
Medical Device
Distribution
Distributed nationwide