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.

26–50 of 58

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
HighFDA (Devices)·Z-2247-2017·2017-06-14
Medtronic Recalls KYPHON Directional Bone Filler Devices Due to Alignment Defect
Medtronic is recalling KYPHON Directional Bone Filler Devices because the directional arrow may not align with the opening, potentially causing cement to be placed in an unintended direction.
Product
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1941-2016·2016-06-15
Materialise Recalls Patient-Specific Knee Surgical Guide Set Due to Fit Error
Materialise USA LLC is recalling a patient-specific knee surgical guide set because the femur guide does not match the patient, preventing proper use during surgery.
Product
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0162-2016·2015-11-04
Materialise Recalls Patient-Specific Knee Surgical Guides Due to Alignment Inaccuracies
Materialise N.V. is recalling four patient-specific surgical guides for knee arthroplasty because image data processing errors led to inaccurate surgical planning.
Product
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2262-2015·2015-08-05
Encore Medical Recalls Foundation Knee System Cut Blocks Due to Marking Error
Encore Medical is recalling 10 units of Foundation Knee System cut blocks because markings are mis-oriented, which could lead to improper surgical cuts.
Product
FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1819-2015·2015-07-01
Orthofix Centurion POCT System Drill Guide Recall for Depth Setting Risk
Orthofix is recalling 36 Centurion POCT System Drill Guides because the thumb button may remain unlocked, allowing the drill stop to rotate unintentionally and change the depth setting.
Product
ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0225-2015·2014-11-26
Medacta MectaLIF Oblique Handle Recalled for Incorrect Laser Marking
Medacta USA is recalling 32 MectaLIF Oblique Handles because incorrect laser markings could lead to improper device insertion during surgery.
Product
The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0075-2015·2014-10-22
Biomet Recalls Discovery Elbow Humeral Trial Due to Incorrect Etching
Biomet is recalling six Discovery Elbow Humeral Trials that were incorrectly manufactured as left-sided but etched as right-sided.
Product
Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and revision joint arthoplasty for use in cemented applications. Elbow joint replacement components include humeral and ulnar components, and
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2575-2014·2014-09-10
Zimmer Persona Knee Trial Articular Surface Provisional Breakage Recall
Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.
Product
PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; R CD +0MM; R CD +6MM; R EF +0MM; R EF +6MM; R GH +0MM; R GH +6MM; R J +0MM; R J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2576-2014·2014-09-10
Zimmer Persona Knee Trial Articular Surface Provisional Recall for Breakage
Zimmer, Inc. is recalling 77,737 Persona Knee Trial Articular Surface Provisional units due to reports of breakage and updated surgical techniques.
Product
PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2182-2014·2014-08-20
Integra Recalls NewPort MIS System Due to Potential Component Mixing
Integra LifeSciences is recalling four units of the NewPort MIS System because demonstration components may have been mixed with surgical components.
Product
Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewPort System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1961-2014·2014-07-09
Integra Recalls NewPort MIS Rod 2 Due to Potential Misalignment
Integra LifeSciences is recalling 94 units of NewPort MIS Rod 2 because the rods may be offset from specifications, potentially causing misalignment during surgical insertion.
Product
MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm). The NewPort MIS Rod 2 is a 5.5 diameter titanium spinal rod used to immobilize adjacent NewPort pedicle screws
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1871-2014·2014-07-02
Intuitive Surgical Recalls Da Vinci Xi Endoscope Accessories Due to Visual Tint
Intuitive Surgical is recalling 19 units of the IS4000 da Vinci Xi 0 Degree, 8mm Endoscope because an orange-yellow tint in the surgical view can make it difficult to differentiate between tissue.
Product
IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1870-2014·2014-07-02
Intuitive Surgical Recalls Da Vinci Xi Endoscope Accessories Due to Visual Tint
Intuitive Surgical is recalling 20 units of the IS4000 da Vinci Xi 30 Degree, 8mm Endoscope because an orange-yellow tint in the surgical view can make it difficult to differentiate between tissue.
Product
IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1469-2014·2014-04-23
Brainlab Spine & Trauma 3D 2.0 Navigation Software Recalled for Registration Defect
Brainlab AG is recalling 133 units of Spine & Trauma 3D 2.0 Navigation Software due to a defect in the fluoro match registration function.
Product
Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-1153-2014·2014-03-19
Carl Zeiss VisuMax Laser Keratome Treatment Packs Recalled for Size Mismatch
Carl Zeiss Meditec AG is recalling VisuMax Laser Keratome treatment packs, Lot M130010, because Size M packs may contain Size S components.
Product
Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0577-2014·2014-01-01
Materialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports
Materialise USA LLC is recalling patient-specific orthognathic surgical guides because they contained incorrect case reports with surgical plan information.
Product
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0578-2014·2014-01-01
Materialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports
Materialise USA LLC is recalling patient-specific orthognathic surgical guides because they contained incorrect case reports with surgical plan information.
Product
ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0334-2014·2013-11-27
Zeiss IOLMaster 500 Recalled for Erroneous Lens Database Value
Carl Zeiss Meditec is recalling 1,201 IOLMaster 500 devices because an incorrect database value for the AMO Sensar AR40E lens could lead to the implantation of lenses with the wrong diopter.
Product
Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use prima
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0333-2014·2013-11-27
Zeiss IOLMaster Recalled for Incorrect Lens Database Value
Carl Zeiss Meditec is recalling 4,907 IOLMaster devices because an incorrect lens constant in the internal database could lead to the implantation of intraocular lenses with the wrong power.
Product
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primari
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0001-2014·2013-10-09
Maquet Recalls Ultima OPCAB Systems Due to Incorrect Blade Labeling
Maquet Cardiovascular is recalling specific lots of Ultima OPCAB Systems because standard and deep blades were incorrectly labeled, posing a risk during cardiac surgery.
Product
Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2000-2013·2013-08-28
Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations
Zimmer is recalling NexGen CR knee components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Femur CR POROUS FEM COMP SIZE AMR Rx, Sterile; 00597201201 Femur CR POROUS FEM COMP SIZE BML Rx, Sterile; 00597201202 Femur CR POROUS FEM COMP SIZE BMR Rx, Sterile; Used in total knee arthroplas
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2033-2013·2013-08-28
Zimmer NexGen Knee System Recalled for Unapproved Component Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile; 00597604112 Articular Surface AC ART SURF 56/STRIPED GRN 12, Rx, Sterile; 00597604114 Articular Surface AC ART SURF 56/STRIPED GRN 14, Rx, Sterile; 00597604117 Articular Surface AC ART SURF 56/STRI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1821-2013·2013-08-07
Synthes Synapse SD Drill Guide Recalled for Incorrect Etching
Synthes USA HQ, Inc. is recalling two Synapse SD Drill Guides with incorrect etching. The error could lead to the use of the wrong drill size during surgery.
Product
Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook an
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1520-2013·2013-06-19
DePuy Glenosphere Orientation Guide Recalled for Incorrect Etched Arrow Placement
DePuy Orthopaedics is recalling Glenosphere orientation guides because an etched arrow is on the wrong side, which could lead to incorrect implant alignment.
Product
DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere.
Category
Medical Device
Distribution
Distributed nationwide