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.

51–75 of 90

HighFDA (Devices)·Z-0874-2015·2014-12-31
Ebi Solitaire-C Cervical Spacer Drill Sleeves Recalled for Design Deficiency
Ebi, LLC is recalling 193 units of Solitaire-C Cervical Spacer System drill sleeves because a design defect allows instruments to penetrate 1.0 mm beyond intended depths.
Product
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1947-2014·2014-07-09
Alcon Anterior Chamber Cannula Recall Due to Incorrect Component
Alcon is recalling CUSTOM-PAKs that contain a sharp tip needle instead of the intended anterior chamber cannula.
Product
Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1756-2014·2014-06-18
Stryker 3.0mm Round Fluted Bur Recalled for Missing Notches
Stryker is recalling 285 sterile 3.0mm Round Fluted Bur Aggressive devices due to missing or partial notches. The defect may affect the device's compatibility with Elite Attachments.
Product
Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appli
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1559-2014·2014-05-14
Teleflex Medical Recalls Bard Fixt Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling Bard Fixt Sutures because the needle may detach from the suture during use, failing to meet minimum strength requirements.
Product
Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.
Category
Medical Device
Distribution
28 states
SevereFDA (Devices)·Z-1561-2014·2014-05-14
Teleflex Medical Recalls Silk Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of Deknatel Silk Sutures because the needle may detach from the suture during use.
Product
Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1557-2014·2014-05-14
Teleflex Medical Recalls Surgical Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of surgical sutures because the needles may detach from the suture during use, failing to meet minimum strength requirements.
Product
Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, B
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1558-2014·2014-05-14
Teleflex Medical Recalls Fixt Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Sutures because the needles may detach during use.
Product
Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1560-2014·2014-05-14
Teleflex Medical Recalls Stainless Steel Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of Deknatel stainless steel sutures because the needle may detach from the suture during use.
Product
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the s
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1556-2014·2014-05-14
Teleflex Medical Recalls Surgical Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of nonabsorbable surgical sutures because the needles may detach from the suture during use.
Product
Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE, Impregn
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1335-2014·2014-04-16
Intuitive Surgical Recalls 5mm Curved Cannulae for da Vinci System
Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System because they may become damaged during use. The recall also includes labeling updates to guide inspection and handling.
Product
5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1332-2014·2014-04-16
Intuitive Surgical Recalls 5mm Curved Cannulae for da Vinci System
Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System due to potential damage during use and to update labeling instructions.
Product
5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1274-2014·2014-04-02
Synthes Ulna Osteotomy System Drill Template and Saw Guide Recall
Synthes, Inc. is recalling 343 Drill Templates and Saw Guides for the Ulna Osteotomy System due to potential mechanical failure of connecting screws or K-wires.
Product
Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1151-2014·2014-03-19
Megadyne Recalls Suction Coagulators Due to Self-Activation Risk
Megadyne Medical Products is voluntarily recalling specific lots of Hand Control 12FR Suction Coagulators because they may self-activate when connected to a generator.
Product
Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0432-2014·2013-12-11
Olympus Recalls Thunderbeat Surgical Instruments Due to Component Damage
Olympus America Inc. is recalling Thunderbeat surgical instruments because they may crack, break, or deform during use.
Product
TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0411-2014·2013-12-04
Biomet Recalls Shortened Plug Driver Due to Instrument Tip Shearing
Biomet is recalling two units of a Shortened Plug Driver after a complaint reported the instrument tip sheared off during a surgical removal case.
Product
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixa
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1957-2013·2013-08-21
SpineFrontier Invue Solid Driver Recalled Due to Broken Nipple
SpineFrontier, Inc. is recalling nine Invue Solid Drivers because the nipple broke off during use, potentially affecting spinal surgery.
Product
Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1685-2013·2013-07-17
Integra Hallu-Fix Cannulated Screw Driver Recall Due to Tip Breakage
Integra LifeSciences is recalling Hallu-Fix cannulated screw drivers and tips because the tips have been reported to break during surgery.
Product
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1620-2013·2013-07-10
Zimmer Recalls Fukuda Retractors Due to Fractures During Surgery
Zimmer, Inc. is recalling Fukuda retractors because they fracture at the grooves during use. The recall includes 722 units distributed worldwide.
Product
Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1621-2013·2013-07-10
Zimmer Recalls Fukuda Retractors Due to Fracture Risk During Surgery
Zimmer, Inc. is recalling Fukuda-type retractors because they may fracture at the grooves during surgical use. This recall expands a 2010 action to include seven additional lots.
Product
Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1061-2013·2013-04-17
Stryker Recalls Baseplate Impactor Extractor Instruments Due to Handle Detachment
Stryker Howmedica Osteonics is recalling 871 Baseplate Impactor Extractor instruments because the handle may detach from the cam during surgery.
Product
Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0650-2013·2013-01-16
California Medical Laboratories Recalls Rigid Tip Suction Wands Due to Tip Detachment Risk
California Medical Laboratories is recalling Rigid Tip Suction Wands because the distal tip may detach and fall into a patient's chest cavity during surgery.
Product
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0644-2013·2013-01-16
Applied Medical Recalls Kii Shielded Bladed Access Systems Due to Blade Exposure Risk
Applied Medical is voluntarily recalling 72 units of Kii shielded bladed access systems because the blade may remain exposed after shield deployment.
Product
Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0471-2013·2012-12-12
Biomet Recalls OSS Knee Reamer Sleeves Due to Sticking Risk
Biomet is recalling 46 OSS Knee Reamer Sleeves because the thin shaft reamer may get stuck and fail to slide into the sleeve.
Product
OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0438-2013·2012-12-05
Extremity Medical Recalls IO FiX X-Post Reamer Due to Intraoperative Breakage
Extremity Medical LLC is recalling 156 units of the IO FiX X-Post Reamer after reports of the device breaking during surgery.
Product
IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-0065-2013·2012-10-24
ConMed Linvatec Recalls Press FT HI-FI Sutures Due to Driver Tip Separation
ConMed Linvatec is recalling Press FT HI-FI Sutures because the driver tip may separate from the shaft after implant insertion.
Product
"***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
Category
Medical Device
Distribution
17 states