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.

51–75 of 156

  • HighFDA (Devices)·Z-2059-2023·2023-07-12

    Fenestrated Graspers Recalled Due to Potential Breakage and Fragment Risk

    Intuitive Surgical is recalling 46,033 da Vinci Xi/X Tip-Up Fenestrated Graspers worldwide due to a manufacturing issue that can cause grip breakage, potentially allowing stainless steel fragments to enter the patient.

    Product
    da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1478-2022·2022-08-03

    Stryker Craniotomy Router May Break and Leave Metal Fragments

    Stryker 2.3mm Tapered Router (craniotomy instrument) may break due to undersized core, leaving metal fragments in the surgical site. This risks damage to critical brain structures or need for additional surgery.

    Product
    Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1698-2021·2021-06-09

    T25 Cannulated Screwdrivers May Break During Surgical Procedures

    T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits may break at the driver tip during use, extending surgery time and requiring additional imaging to identify fragments.

    Product
    T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0571-2021·2020-12-23

    DePuy Synthes 10.0MM Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 10.0MM Reamer Heads for RIA 2 because breakage exceeds expected rates, causing potential tissue or bone damage.

    Product
    DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0584-2021·2020-12-23

    DePuy Synthes 16.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 16.5mm reamer heads because breakage exceeds expected rates, causing tissue and bone damage.

    Product
    DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0577-2021·2020-12-23

    DePuy Synthes 13.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 13.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0583-2021·2020-12-23

    DePuy Synthes 16.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 16.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0574-2021·2020-12-23

    DePuy Synthes 11.5mm Reamer Head Recalled for Breakage Risk

    Synthes (USA) Products LLC is recalling DePuy Synthes 11.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0580-2021·2020-12-23

    DePuy Synthes 14.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 14.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0586-2021·2020-12-23

    DePuy Synthes 17.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 17.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0572-2021·2020-12-23

    DePuy Synthes 10.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 10.5mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0578-2021·2020-12-23

    DePuy Synthes 13.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 13.5mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0582-2021·2020-12-23

    DePuy Synthes 15.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 15.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2730-2020·2020-08-05

    Teleflex Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage

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

    Product
    Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (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-2008-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling 211 units of the Aleutian Interbody Spacer Systems, EN AN 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 # 5203-90107, UDI # 10888857108202, Size 24x4mm, 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-2016-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for 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 # 5203-90127, UDI # 10888857108400, Size 24x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2011-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreaders 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 # 5203-90113, UDI # 10888857108264, Size 24x10mm, 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
  • HighFDA (Devices)·Z-2028-2020·2020-05-27

    K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk

    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 # 5203-90169, UDI # 10888857108820, Size 28x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2020·2020-04-08

    Stryker AXS Vecta 71 Aspiration Catheter Recall for Breakage Risk

    Stryker Neurovascular is recalling AXS Vecta 71 Aspiration Catheters because they may break, fracture, or kink if improperly removed or during use.

    Product
    Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459210(17)211129(10)00000-00 Stryker Neurovascula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2020·2019-11-27

    Auris Health Recalls Monarch Aspirating Biopsy Needles Due to Breakage Reports

    Auris Health is recalling 158 Monarch Aspirating Biopsy Needles because of reports of needle breakage. The devices were distributed to 11 states.

    Product
    Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2376-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling Equistream XK Alphacurve Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2383-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393190, 14.5F, Straight, 19cm length, BARD, UDI: 00801741012174
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2384-2019·2019-09-04

    Bard Hemodialysis Catheter Recalled for Molded Tip Breakage During Placement

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during the placement procedure.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393230, 14.5F, Straight, 23cm length, BARD, UDI: 00801741012181
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Devices)·Z-2266-2019·2019-08-21

    Medline Silicone Drain Recalled for Risk of Breaking During Use

    Degania Silicone is recalling 200 units of Medline Silicone Drains because they may break during use, requiring additional surgery to remove the broken end.

    Product
    Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2265-2019·2019-08-21

    Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk

    Degania Silicone is recalling 2,160 units of Cardinal Health Jackson-Pratt Channel Drains because they may break during use, potentially requiring additional surgery.

    Product
    Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than bloo
    Category
    Medical Device
    Distribution
    Distributed nationwide