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.

26–50 of 156

  • SevereFDA (Devices)·Z-1455-2026·2026-03-04

    Olympus Inner Sheath Model A2641 Recalled Over Ceramic Tip Breakage

    Olympus is recalling all lots of its Inner Sheath, Model A2641, used in urological endoscopic procedures, due to complaints that the ceramic tip can break during use.

    Product
    Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1446-2026·2026-03-04

    Olympus resection sheath recalled due to ceramic tip breakage

    Olympus is recalling 207 units of its Resection Sheath, Model A22043T, after receiving complaints that the ceramic tip can break during use. The recall affects all lots distributed nationwide.

    Product
    Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1453-2026·2026-03-04

    Olympus Inner Sheath 21 Fr. Model A2660T Medical Device Recall

    Olympus is recalling all lots of its Inner Sheath 21 Fr. Model A2660T used in urological procedures due to reports of the ceramic tip breaking during use.

    Product
    Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2026·2026-03-04

    Olympus long inner sheath recalled after ceramic tip breakage complaints

    Olympus is recalling its Inner Sheath, Long, model WA22017A, used in urological and gynecological applications, after complaints that the ceramic tip of the resection sheath can break.

    Product
    Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2026·2026-03-04

    Olympus resection sheath recalled due to ceramic tip breakage

    Olympus is recalling 3,484 Resection Sheaths, Model A22041A, after receiving complaints that the ceramic tip can break during urologic procedures. The recall covers all lots distributed nationwide.

    Product
    Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2026·2026-03-04

    Olympus resection sheath models A22014A and A22014T recalled for breakage

    Olympus is recalling Resection Sheath models A22014A and A22014T, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip can break.

    Product
    Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1440-2026·2026-03-04

    Olympus resection inner sheath recalled after ceramic tip breakage complaints

    Olympus is recalling its Resection Inner Sheath for 26 Fr outer sheath, model A22040T, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.

    Product
    Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1445-2026·2026-03-04

    Olympus 28 French resection sheath recalled over ceramic tip breakage

    Olympus is recalling its Resection Sheath, 28 Fr, model A22043A, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.

    Product
    Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1439-2026·2026-03-04

    Olympus resection inner sheath A22040A recalled over ceramic tip breakage

    Olympus is recalling its Resection Inner Sheath for 26 Fr outer sheath, model A22040A, used in urologic applications, after complaints that the ceramic tip can break.

    Product
    Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1444-2026·2026-03-04

    Olympus 26 French resection sheath recalled over ceramic tip breakage

    Olympus is recalling its Resection Sheath, 26 Fr, with Deflecting Obturator, model A22042T, used in urologic applications, after complaints that the ceramic tip can break.

    Product
    Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2026·2026-03-04

    Olympus 10 French sheath recalled over ceramic tip breakage complaints

    Olympus is recalling its Sheath, 10 Fr, model A37004A, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip can break.

    Product
    Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2026·2026-03-04

    Olympus 24 French resection sheath recalled over ceramic tip breakage

    Olympus is recalling its Resection Sheath, 24 Fr, with Deflecting Obturator, model A22041T, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.

    Product
    Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2026·2026-03-04

    Olympus inner sheath model A2660 recalled over ceramic tip breakage

    Olympus is recalling its Inner Sheath, model A2660, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip of the resection sheath can break.

    Product
    Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2026·2026-03-04

    Olympus resection sheath recalled after reports of ceramic tip breaking

    Olympus is recalling its Resection Sheath model A2666T, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip of the sheath can break.

    Product
    Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1448-2026·2026-03-04

    Olympus Gynecological Resection Sheath Recalled Over Ceramic Tip Breakage

    Olympus is recalling 899 units of its 8 mm Resection Sheath (Model A42011A) used in gynecological procedures after receiving complaints that the ceramic tip can break during use.

    Product
    Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2485-2025·2025-09-10

    Spinal decompression implants recalled after review found instrument and device breakage

    Superion Indirect Decompression System implants and kits are recalled because a product performance review found the device and instruments are not consistently meeting expected performance, including breakage. 70,516 units are affected.

    Product
    Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1404-2025·2025-03-26

    CAPNOCHECK BCI Airway Adapter may break off, causing ventilation failure

    The CAPNOCHECK BCI Airway Adapter (Model BSR) may break when attached to a valve or tube, risking airway circuit failure and loss of ventilation. Approximately 175,994 units were recalled nationwide.

    Product
    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3301-2024·2024-10-02

    Cardinal Health Recalls Salem Sump Stomach Tubes Due to Valve Breakage

    Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes because the Anti-Reflux Valve may break due to improper use. Labeling changes were made to address the issue.

    Product
    (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888264945, Sterile; (c) CardinalHealth Salem Sump Dua
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3010-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline is recalling medical convenience kits due to plastic syringe leaks, breakage, and quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER INSERTION KIT CLABSI , Pack Number CVI4880; 4) CHEST INSERTION PACK-LF , Pack Number DYNJ17634D ; 5) URETEROSCOPY, Pack Number D
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2579-2024·2024-08-21

    Merit Medical Convenience Kits Recalled for Syringe Leaks and Breakage

    Merit Medical is recalling medical convenience kits with defective syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health during procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K05-02166B K05T-00380C K05T-01674B K05T-01863 K05T-01941C K05T-01955 K05T-02138 K05T-02159 K05T-02272G K05T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2024·2024-05-29

    Olympus InstaClear Lens Sheath Recalled for Potential Distal End Breakage

    Olympus has recalled InstaClear Lens Sheaths used in rigid endoscopy because the distal end may break off during procedures. All lot numbers of multiple model variants distributed in the U.S. and internationally are affected.

    Product
    InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0676-2024·2024-01-17

    BD Recanalization System May Overheat or Break During Use

    Bard Peripheral Vascular is recalling BD Recanalization Systems due to a manufacturing defect that may allow continuous operation without required safety warnings, increasing risk of device overheating or breaking during patient treatment.

    Product
    BD Recanalization System, REF: BDRECANSYSTEM
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0618-2024·2024-01-03

    Acumed RibLoc U Plus 90 Surgical Guide Recalled for Potential Breakage

    Acumed LLC recalls 513 RibLoc U Plus 90 surgical guides due to potential breakage during use. The device is used in orthopedic rib fixation procedures.

    Product
    RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a power system to compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes
    Category
    Medical Device
    Distribution
    Distributed nationwide