The Recall Desk

Hazard

Breakage recalls

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

What the numbers show

Total
207
Critical
2
Severe
24
Most recent
2026-07-22

Of the 207 breakage recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 24 (12%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all 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.

151–175 of 207

  • HighFDA (Devices)·Z-1019-2019·2019-03-27

    AAP Implantate Lambotte Chisel Recalled for Potential Breakage at Welded Parts

    AAP Implantate AG is recalling 25 units of the 20 mm Lambotte chisel due to a potential risk of breaking at the welded piece parts of the chisel body and knocking plate.

    Product
    aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0754-2019·2019-01-30

    Teleflex Percuvance Percutaneous Shaft Recall Due to Tip Breakage Risk

    Teleflex Medical is recalling 1,962 units of Percuvance Percutaneous Shafts because the distal tip may deform or break off during use, potentially requiring surgical intervention.

    Product
    Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver He
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0442-2019·2018-11-21

    Arthrex Recalls 3.2mm Proximal Reamer Due to Potential Breakage During Use

    Arthrex, Inc. is recalling 832 units of the 3.2mm Proximal Reamer/Cannulated Drill because the instrument may break during use.

    Product
    3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spa
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Devices)·Z-2548-2018·2018-08-01

    Cayenne Medical Recalls AperFix Femoral Implant Coring Removal Drills

    Cayenne Medical Inc. is recalling specific models of the AperFix Femoral Implant Coring Removal Drill due to a trend of premature wear and breakage identified in 2010.

    Product
    AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2161-2018·2018-06-20

    Maquet Aortic Arterial Cannula Recall Due to De-airing Plug Breakage Risk

    Maquet Cardiopulmonary Ag is recalling specific lots of Aortic Arterial Cannulas because the de-airing plugs may break during removal.

    Product
    Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1877-2018·2018-05-23

    Micro-Tech Trident Endoscopic Ultrasonic Biopsy Needle Recall

    Micro-Tech is recalling 40 Trident Endoscopic Ultrasonic Biopsy Needles because they may break in the human body, potentially causing injury.

    Product
    Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1100-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage

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

    Product
    Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 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-1102-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage

    Boston Scientific is recalling Re-Entry Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.

    Product
    Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography "
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0848-2018·2018-03-14

    DePuy Concorde Lift Driver Shaft Recalled for Potential Breakage

    DePuy Orthopaedics is recalling 130 units of the Concorde Lift Driver Shaft AO due to a potential for intra-operative breakage of driver tips.

    Product
    Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0849-2018·2018-03-14

    DePuy Concorde Lift Torque Limiting Handle Recalled for Breakage Risk

    DePuy Orthopaedics is recalling 130 Concorde Lift Torque Limiting Handles due to a potential for intra-operative breakage of driver tips.

    Product
    Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0644-2018·2018-02-28

    Innovasis Recalls Nine Lots of 8.5 mm Polyaxial Pedicle Screws

    Innovasis, Inc. is recalling nine lots of 8.5 mm Polyaxial Pedicle Screws due to a risk of breakage. The recall covers 1,010 parts distributed in the United States.

    Product
    Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumba
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0207-2018·2017-12-13

    BD Precision Glide Needles Recalled for Hub Damage and Leakage

    Becton Dickinson is recalling 2,598,000 BD Precision Glide Needles due to hub damage that can cause breakage or leakage during use.

    Product
    BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2018·2017-11-15

    Lima Delta Cup Beater Positioner Recalled for Potential Welding Defects

    Lima is recalling 20 Delta Cup Beater Positioner units in the US due to suboptimal welding that may reduce mechanical strength and cause breakage during use.

    Product
    Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3139-2017·2017-09-27

    Medtronic Spine Referencing Clamp Recall for Potential Breakage

    Medtronic is recalling Spine Referencing Instrumentation clamps due to a risk of breakage that could leave components in the patient's body.

    Product
    Spine Referencing Instrumentation, Spinous Process Clamp, 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 the duration of the surgery
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-2616-2017·2017-06-28

    DePuy Mitek LATARJET Coracoid Drill Recalled for Breakage Risk

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

    Product
    DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 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-2162-2017·2017-05-31

    CORPAK Recalls CORFLO PEG Adaptor Repair Kits Due to Breakage Risk

    CORPAK MedSystems is voluntarily recalling CORFLO PEG Adaptor Repair Kits because the barb connector may break under stress.

    Product
    CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. T
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2163-2017·2017-05-31

    CORPAK CORFLO PEG Kit Recall Due to Potential Connector Breakage

    CORPAK MedSystems is voluntarily recalling CORFLO PEG Kits because the ENFit connector stem may break unexpectedly under stress.

    Product
    CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceabl
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2161-2017·2017-05-31

    CORPAK CORFLO PEG Adaptor Repair Kit Recalled for Connector Breakage

    CORPAK MedSystems is voluntarily recalling CORFLO PEG Adaptor Repair Kits because the barb connector may break unexpectedly when exposed to stress.

    Product
    CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm); Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syri
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0650-2017·2016-11-30

    DePuy ACTIS Flex Reamers Recalled Due to Breakage Risk

    DePuy Orthopaedics is voluntarily recalling ACTIS Flex Reamers because the instruments may break and leave pieces in patients.

    Product
    ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2765-2016·2016-09-14

    Hologic Recalls SureSight Obturator Introducer Systems Due to Tip Breakage

    Hologic is recalling 1,440 SureSight Obturator Introducer Localization Systems because the tip may break at the glue joint.

    Product
    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2373-2016·2016-08-17

    Ivoclar Vivadent Recalls OptraPol Dental Polishing Discs Due to Breakage

    Ivoclar Vivadent is recalling OptraPol polishing discs and cups because parts break away during use. The recall covers 86 units distributed in 16 states.

    Product
    OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalga
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2389-2016·2016-08-17

    Synthes 2.4mm Titanium Locking Screws Recalled for Breakage Risk

    Synthes (USA) Products LLC is recalling 41 units of 2.4mm Titanium Locking Screws because they can break between the head and shaft due to a thin wall design.

    Product
    Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices The 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm is a
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-2238-2016·2016-07-27

    Stryker 2.3mm Tapered Routers Recalled Due to Breakage Risk

    Stryker is recalling 2.3mm Tapered Routers because a variation in flute depth may cause breakage, posing a risk of injury to critical soft tissue.

    Product
    2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otology /Neurotology/ Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and St
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0125-2016·2015-10-21

    Synthes Recalls Titanium Elastic Nail Inserters Due to Mechanical Failure Risk

    Synthes (USA) Products LLC is recalling 1,550 Inserter for Titanium Elastic Nails (TEN) devices due to a potential for mechanical failures such as breakage.

    Product
    Inserter for Titanium Elastic Nails (TEN), orthopedic device
    Category
    Medical Device
    Distribution
    Distributed nationwide