The Recall Desk

Hazard

Device Breakage recalls

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

What the numbers show

Total
156
Critical
1
Severe
41
Most recent
2026-08-12

Of the 156 device breakage recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 41 (26%) 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 device breakage 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.

101–125 of 156

  • HighFDA (Devices)·Z-1795-2018·2018-05-16

    TP Orthodontics Recalls Jasper Vektor Class II Correction Appliance

    TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices have broken in patients' mouths, posing a risk of injury.

    Product
    Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1641-2018·2018-05-16

    Medtronic Prestige LP Cervical Disc Drill Guides Recalled for Breakage

    Medtronic is recalling specific drill guides for the Prestige LP Cervical Disc System because they may cause drill bits to break during use.

    Product
    Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2018·2018-05-02

    Integra LifeSciences Recalls Humeral Stem Trials for Breakage Risk

    Integra LifeSciences is recalling 1,619 humeral stem trials for the Titan Modular Shoulder System because they may break during surgery.

    Product
    The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Hum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1104-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Mid-Shaft Breakage

    Boston Scientific is recalling certain Malecot Nephrostomy Catheters because they are breaking at the mid-shaft bond during use.

    Product
    Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Mid-Shaft Breakage

    Boston Scientific is recalling Malecot Nephrostomy Catheter Sets because they are breaking at the mid-shaft bond during use.

    Product
    Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage

    Boston Scientific is recalling 422 units of Malecot Nephrostomy Catheters because they may break at the mid-shaft bond during use.

    Product
    Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collecting system while maintaining external access. The Stenting Malecot Nephrostomy C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2018·2018-01-03

    Orthofix Power Drill Torque Limiter Recalled Due to Breakage Risk

    Orthofix Srl is recalling 416 units of Power Drill Torque Limiters because they may break during surgical use. The devices are used for temporary bone stabilization in lower limb procedures.

    Product
    Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-3143-2017·2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Breakage

    Medtronic Navigation is recalling Spine Referencing Instrumentation sets due to a risk that clamps may break during use, potentially leaving components in the patient's body.

    Product
    Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for th
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-3140-2017·2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Damage

    Medtronic is recalling Spine Referencing Instrumentation because the clamps may be damaged if opened beyond limits, potentially leaving components in the patient.

    Product
    Spine Referencing Instrumentation, Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surger
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-3142-2017·2017-09-27

    Medtronic Spine Referencing Instrumentation Recalled for Potential Breakage

    Medtronic is recalling Spine Referencing Instrumentation, Double Spinous Process Clamp, Short units because they may break during use, potentially leaving components in the patient's body.

    Product
    Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the
    Category
    Medical Device
    Distribution
    44 states
  • 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
  • CriticalFDA (Devices)·Z-2702-2017·2017-07-26

    Penumbra 3D Revascularization Device Recalled Due to Delivery Wire Breakage Risk

    Penumbra Inc. is recalling 155 units of the 3D Revascularization Device because a raw material issue could cause the delivery wire to break, potentially leading to serious injury or death.

    Product
    Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2617-2017·2017-06-28

    DePuy Mitek LATARJET Drill Tip Recall Due to Breakage Risk

    DePuy Mitek is recalling LATARJET Coracoid Top Hat Drills because the Combo Screw Driver tip may break during surgery.

    Product
    DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2619-2017·2017-06-28

    DePuy Mitek LATARJET Extraction Driver Recalled for Breakage Risk

    DePuy Mitek is recalling 115 units of the LATARJET EXPERIENCE Extraction Driver because the tip may break during surgery when used at an angle.

    Product
    DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2615-2017·2017-06-28

    DePuy Mitek LATARJET Combo Screw Driver Recalled for Breakage Risk

    DePuy Mitek is recalling 173 LATARJET Combo Screw Drivers because the tip may break during surgery when used at an angle.

    Product
    DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-1252-2017·2017-03-08

    Olympus Uretero-reno Videoscope Recall Due to Insertion Tube Breakage

    Olympus is recalling URF-V2 and URF-V2R endoscopes because the insertion tube bending section may break during surgery, causing tissue trauma.

    Product
    Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0702-2017·2016-12-14

    Thayer MANOS EX Surgical Device Recalled for Missing Safety Warning

    Thayer Intellectual Property, Inc. is recalling 339 MANOS EX surgical devices because customers were not notified of a critical safety warning regarding device bending and breakage.

    Product
    MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar fas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0067-2017·2016-10-19

    Brathwaites Oliver Medical Recalls Introes Pocket Bougie Endotracheal Tube Introducers

    Brathwaites Oliver Medical is recalling Introes Pocket Bougie endotracheal tube introducers because the device may break during intubation.

    Product
    The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-2386-2016·2016-08-17

    Integra External Fixation System Wire Fixation Bolts Recalled for Breakage

    Integra LifeSciences Corp. is recalling Universal Wire Fixation Bolts because the Slotted Post broke during use at the surgical site.

    Product
    Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1711-2016·2016-06-01

    Limacorporate SMR Glenosphere Impactor/Extractor Recalled for Intra-operative Breakage

    Limacorporate is recalling 314 SMR glenosphere impactor/extractor units due to reports of breakage during surgery. The devices were distributed in the US and Australia.

    Product
    SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0478-2016·2016-01-13

    Stryker Fuhrman Pleural Drainage Set Recalled for Breakage During Insertion

    Stryker is recalling 34 Fuhrman Pleural/Pneumopericardial Drainage Sets because they broke off in the pleural cavity during patient insertion.

    Product
    The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2359-2015·2015-08-19

    Synthes Recalls 8.5mm Reamer Heads for Potential Intraoperative Breakage

    Synthes (USA) Products LLC is recalling 8.5mm Reamer Heads for Flexible Intramedullary Nailing Systems due to the possibility of intraoperative breakage and un-retrieved material fragments.

    Product
    8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2092-2015·2015-07-22

    Synthes Recalls RIA Drive Shafts and Reamer Heads Due to Breakage Risk

    Synthes, Inc. is recalling Reamer / Irrigator / Aspirator (RIA) components because they may break if incorrectly assembled or used improperly.

    Product
    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary imp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1721-2015·2015-06-17

    Vilex FUZE Ankle Arthrodesis Screws Recalled Due to Breakage

    Vilex, Inc. is recalling 13 units of FUZE 10.0 mm x 150 mm ankle arthrodesis screws because the incidence of breakage is higher than expected.

    Product
    Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1021-2015·2015-02-04

    Synthes 2.0 Mandible Locking Plate Bender Recall for Tip Breakage

    Synthes, Inc. is recalling 973 units of the 2.0 Mandible Locking Plate Bender/Cutter because the tips may break during use, potentially delaying surgery.

    Product
    2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
    Category
    Medical Device
    Distribution
    0 states