The Recall Desk

Hazard

Device Failure recalls

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

What the numbers show

Total
881
Critical
30
Severe
255
Most recent
2026-09-02

Of the 881 device failure recalls we have scored against our rubric, 30 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (29%) 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 failure 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 881

  • HighFDA (Devices)·Z-1452-2026·2026-03-04

    Olympus Resection Sheath Model A2666 Recalled Due to Ceramic Tip Breakage

    Olympus recalls Model A2666 Resection Sheath for urologic use after receiving complaints of the ceramic tip breaking during procedures.

    Product
    Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2026·2026-03-04

    Olympus Inner Sheath Medical Device Recall for Ceramic Tip Breakage

    Olympus recalls 91 units of its Inner Sheath Model A4741 medical device after receiving complaints of the ceramic tip breaking during gynecological endoscopic procedures.

    Product
    Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2026·2026-02-25

    Medline Industries IV Administration and Extension Sets Recalled Due to Potential Leaks

    Medline Industries, LP is recalling various IV administration and extension sets because male luer connectors may leak, crack, or break during use.

    Product
    Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2026·2026-02-04

    Biocomposite suture anchors recalled after reports of breakage and bending

    Aju Pharm is recalling 1,088 units of the Fixone Biocomposite Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    Fixone Biocomposite Anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2026·2026-02-04

    Push-in suture anchors recalled after reports of breakage and pull out

    Aju Pharm is recalling 200 units of the Genesis Push-In Suture Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    Genesis Push-In Suture Anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1213-2026·2026-02-04

    Hybrid suture anchors recalled after reports of breakage and pull out

    Aju Pharm is recalling 233 units of the Fixone Hybrid Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1172-2026·2026-02-04

    Knotless suture anchors recalled after reports of breakage and pull out

    Aju Pharm is recalling 2,569 AlternatiV+ Max Knotless Anchors after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    AlternatiV+ Max Knotless Anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0437-2026·2026-02-04

    Genesis knotless anchors recalled after reports of device failure

    Aju Pharm is recalling 1,163 units of the Genesis Knotless Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    Goldenroot Lemon Ginger Hibiscus Ginger Beer. 12 oz. (355 ml) UPC 8 50052-32821 4. Keep Cold. Manufactured By Goldenroot, 3841 Market St #113, Denton, TX 76209.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1173-2026·2026-02-04

    AlternatiV+ screw-in anchors recalled after reports of device failure

    Aju Pharm is recalling 416 units of the AlternatiV+ Screw-In Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    AlternatiV+ Screw-In Anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1168-2026·2026-02-04

    Screw-in suture anchors recalled after reports of breakage and bending

    Aju Pharm is recalling 600 units of the Genesis Screw-In Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    Genesis Screw-In Anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1207-2026·2026-02-04

    Dual thread screw-in anchors recalled after reports of device failure

    Aju Pharm is recalling 400 units of the Genesis Dual Thread Screw-In Anchor after reports of device failure including anchor breakage, bending, pull out and suture breakage.

    Product
    Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2617-2025·2025-10-08

    Atlan A350XL anesthesia workstations recalled after piston ventilator failures during use

    Draeger is recalling 223 Atlan A350XL anesthesia workstations that either indicated a piston ventilator failure before use or suffered a mechanical ventilation failure during use.

    Product
    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ve
    Category
    Medical Device
    Distribution
    25 states
  • CriticalFDA (Devices)·Z-2616-2025·2025-10-08

    Atlan A350 anesthesia workstations recalled after mechanical ventilation failures were reported

    Draeger is recalling 530 Atlan A350 anesthesia workstations that either indicated a piston ventilator failure before use or suffered a mechanical ventilation failure during use.

    Product
    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical vent
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2637-2025·2025-10-08

    Junctional tourniquet devices recalled over manufacturing defect affecting structural integrity

    North American Rescue is recalling 552 Junctional Emergency Treatment Tools over a potential manufacturing defect that may compromise structural integrity and performance during use.

    Product
    JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2566-2025·2025-10-01

    Intubation trays recalled after laryngoscope handle lights failed to illuminate

    Medline is recalling 2,520 intubation and airway kits containing Flexicare BritePro Solo fiber optic laryngoscope handles because the light may fail to illuminate as intended.

    Product
    Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4. INTUBATION KIT, Kit Number ACC010467A; 5. ADULT AIRWAY TRAY, Kit Number ACC01
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2102-2025·2025-07-23

    i-view video laryngoscopes may be faulty because of depleted batteries

    The i-view video laryngoscope is being recalled because of the potential for faulty devices as a result of depleted batteries. 2,152 pieces are affected.

    Product
    i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-2048-2025·2025-07-09

    Philips Ultrasound Transducers Recalled After Over-Refurbishment

    Philips Ultrasound, Inc is recalling 5,230 Philips 3D9-3v Transducer devices because they were refurbished beyond their useful life, posing a risk of device failure during medical use.

    Product
    Philips 3D9-3v Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1997-2025·2025-07-02

    Bigfoot Unity Diabetes Management System Pen Caps Unresponsive Due to Firmware Error

    Bigfoot Biomedical is recalling Bigfoot Unity Diabetes Management System Pen Caps due to a firmware issue that may cause insulin pens to become unresponsive. People with diabetes may lack information needed to make timely treatment decisions.

    Product
    Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1902-2025·2025-06-25

    Cook Beacon Tip Angiographic Catheters Recalled for Tip Separation Risk

    Cook Incorporated is recalling specific lots of Beacon Tip 5.0 Fr Angiographic catheters due to the risk that the catheter tip may separate during use. The affected catheters were distributed worldwide.

    Product
    Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coati
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1866-2025·2025-06-18

    Z-800F Infusion System Recall Due to Unvalidated Software Versions

    Zyno Medical LLC is recalling the Z-800F Infusion System because unreleased software versions were installed on distributed devices without verification or validation. This poses a risk to patients receiving intravenous infusion therapy.

    Product
    Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1809-2025·2025-06-11

    Medline Surgical Kits with Codman Disposable Perforator recalled

    Medline surgical kits containing Codman Disposable Perforators are being recalled because certain lots have inadequate welds that may cause the perforator to break or separate during use.

    Product
    Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1811-2025·2025-06-11

    Medline Craniotomy Kits with Defective Codman Disposable Perforators Recalled

    Medline is recalling multiple craniotomy kits containing Codman Disposable Perforators due to inadequate welds that may cause the perforators to break or separate during use.

    Product
    Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B DYNJ908723A DYNJ908723C 4. CRANIOTOMY #IMF 56646-LF SKU DYN
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1716-2025·2025-05-14

    CODMAN Disposable Cranial Perforator 14mm Recalled Due Weld Issue

    Integra LifeSciences is recalling CODMAN Disposable Perforators (14mm) due to inadequate welds that could cause disassembly during use. The affected devices have been distributed worldwide.

    Product
    CODMAN Disposable Perforator, 14mm. Cranial perforator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1699-2025·2025-05-07

    Distal Femoral Augment medical device recall for defective screw

    Waldemar Link GmbH & Co. KG is recalling Distal Femoral Augment devices because the preassembled femoral augment screw was missing its thread. The defect may affect proper device function.

    Product
    Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 88
    Category
    Medical Device
    Distribution
    Distributed nationwide