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.

126–150 of 207

  • HighFDA (Devices)·Z-1776-2022·2022-09-28

    FDA Recalls Grappler Suture Anchors Due to Potential Breakage Risk

    Paragon 28, Inc. is recalling Grappler Suture Anchors (REF: P44-110-3010-SK, Lot 5007499) due to risk that the anchor may break upon insertion, potentially leaving debris in patients and delaying surgery.

    Product
    Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2022·2022-07-27

    Spinal Fixation Device Removal Key Recalled Due to Potential Fracture Risk

    Aesculap Implant Systems recalls ENNOVATE MIS REMOVALKEY SHORT due to fracture risk if removal key is not used at 90-degree angle. Affected units distributed in CA, CO, IL, MI, OH, and TX.

    Product
    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0853-2022·2022-04-06

    Surgical Drill System Instrument Pack Recalled Over Device Breakage Risk

    Wright Medical is recalling 176 packs of the EasyFuse Dynamic Compression System Instrument Pack due to risk that the drill guide can jam and break during surgery.

    Product
    EasyFuse Dynamic Compression System Instrument Pack
    Category
    Medical Device
    Distribution
    4 states
  • HighCPSC·21181·2021-08-18

    Hallmark Teether Rings Recalled Due to Choking Hazard

    Hallmark is recalling approximately 15,500 wooden teether rings with plush attachments because the wooden ring can break into small parts, creating a choking hazard. The company has received four reports of the rings breaking, including one case where a child placed broken pieces in their mouth.

    Product
    Teether Rings with Decorative Fabric and Plush Attachments
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2021·2021-06-02

    Dentech Corp. Recalls Rubber Dam Clamps Due to Possible Breakage

    Dentech Corp. is recalling 87,842 units of KSK Rubber Dam Clamps because they may break during use. The recall covers units distributed in the US and worldwide.

    Product
    Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21136·2021-05-19

    IKEA Recalls PLA Bowls, Plates, and Mugs Due to Burn Hazard

    IKEA is recalling HEROISK and TALRIKA bowls, plates, and mugs made of PLA material because they can become brittle and break, causing hot contents to leak and burn consumers.

    Product
    IKEA Recalls Bowls, Plates, and Mugs Due to Burn Hazard
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2021·2021-03-31

    In2Bones Shannon Percutaneous Burr Recalled for Potential Breakage During Use

    In2Bones is recalling 60 units of Shannon Percutaneous Burrs due to manufacturing non-conformity that may cause the burr to break during surgery.

    Product
    In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1294-2021·2021-03-31

    Teleflex Recalls Rusch Polaris Laryngoscopes Due to Handle Cracking

    Teleflex is voluntarily recalling Rusch Polaris laryngoscopes because customers reported that the handles develop cracks or break at the hinge.

    Product
    RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0960-2021·2021-02-17

    Cook Medical Kwart Retro-Inject Ureteral Stent Set Recalled for Material Defect

    Cook Inc. is recalling 42 units of Kwart Retro-Inject Ureteral Stent Sets because they were manufactured with incorrect material, which may cause the stent to be stiffer and susceptible to degradation, breakage, or fragmentation.

    Product
    Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0585-2021·2020-12-23

    DePuy Synthes 17.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 17.0mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0576-2021·2020-12-23

    DePuy Synthes 12.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 12.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0575-2021·2020-12-23

    DePuy Synthes 12.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 12.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0573-2021·2020-12-23

    DePuy Synthes 11.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 11.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2999-2020·2020-09-30

    ArthroCare Speed Stitch Needle Cassettes Recalled for Potential Breakage

    ArthroCare is recalling Speed Stitch Needle Cassettes because a supplier error may have resulted in needles made of titanium instead of stainless steel, posing a risk of breakage during use.

    Product
    Speed Stitch Needle Cassette
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2731-2020·2020-08-05

    Teleflex Rusch Greenlite Laryngoscopes Recalled for Welded Joint Breakage

    Teleflex Medical is recalling Rusch Greenlite laryngoscopes because the welded joints may break. The devices are used for tracheal intubation.

    Product
    Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2017-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Lordotic Spreader because the welded tip may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90135, UDI # 10888857108486, Size 24x4mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2024-2020·2020-05-27

    K2M Recalls Aleutian Lordotic Spreader Due to Breakage Risk

    K2M, Inc. is recalling the Aleutian Lordotic Spreader because the welded tip may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90157, UDI # 10888857108707, Size 28x12mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2018-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Welded Tip Breakage

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip can break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90137, UDI # 10888857108509, Size 24x6mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 10888857108622, Size 28x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2014-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Interbody Spacer Systems Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 10888857108363, Size 24x6mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreader systems because the welded tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90139, UDI # 10888857108523, Size 24x8mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1798-2020·2020-05-06

    Boston Scientific Recalls MoXy Laser Fiber for Breakage Risk

    Boston Scientific is recalling MoXy Laser Fibers to update instructions and reduce the likelihood of metal cap and fiber tip breakage.

    Product
    MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1117-2020·2020-02-19

    Teleflex Recalls Rusch Greenlite Laryngoscope Blades Due to Breakage Reports

    Teleflex Medical Inc. is recalling Rusch Greenlite Single-Use Metal Laryngoscope Blades because they may break at a welded joint during setup or use.

    Product
    Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2435-2019·2019-09-11

    Integra Jarit GEMINI CLAMP Recalled Due to Potential Instrument Breakage

    Integra LifeSciences Corp. is recalling 237 units of the Jarit GEMINI CLAMP because a small crack may cause corrosion and breakage after repeated sterilization.

    Product
    Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
    Category
    Medical Device
    Distribution
    Distributed nationwide