The Recall Desk

Hazard

Device Malfunction recalls

1,800 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,800
Critical
31
Severe
370
Most recent
2026-09-02

Of the 1,800 device malfunction recalls we have scored against our rubric, 31 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 370 (21%) 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 device malfunction 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.

101–125 of 1800

  • HighFDA (Devices)·Z-1479-2026·2026-03-11

    Olympus lithotripsy generator recalled over transducer recognition failure

    Olympus is recalling the ShockPulse-SE Lithotripsy System Generator after further instances of the generator remaining in a blinking phase waiting to recognize the transducer.

    Product
    Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2026·2026-03-04

    Olympus Cystoscope Outer Sheath Recalled Due to Potential Device Tip Damage

    Olympus Corporation of the Americas is recalling Olympus Cystoscope Outer Sheath (Model WA22810A) because it may be incompatible with GreenLight Laser therapy, potentially damaging the device tip.

    Product
    Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1362-2026·2026-02-25

    Wilson-Cook Medical Recalls Teslatome Bipolar Sphincterotomes Over Current Path Risk

    Wilson-Cook Medical Inc. is recalling 153 Teslatome Bipolar Sphincterotomes due to a potential void in the material separating the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.

    Product
    Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloade
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1382-2026·2026-02-25

    Olympus Thunderbeat Surgical Device Recall Over Adverse Events

    Olympus is recalling 1,538 Thunderbeat 5 mm surgical devices worldwide due to continued reports of adverse events. The recall affects all units of Model No. TB-0510IC.

    Product
    Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1379-2026·2026-02-25

    Olympus Thunderbeat Grip Medical Device Recall for Adverse Events

    Olympus Corporation is recalling 30 Thunderbeat 5 mm, 45 cm Inline Grips due to continued reports of adverse events during medical procedures.

    Product
    Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1427-2026·2026-02-25

    Stryker MOLLI 2 System Recall: Marker Dislodgement Risk

    Stryker is recalling the MOLLI 2 System due to magnetized surgical tools that may dislodge markers during target tissue removal procedures. The recall affects 5,864 units distributed worldwide.

    Product
    MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 008500241951
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2026·2025-10-22

    TENACIO pumps without InhibiZone recalled over inflation and deflation issues

    Boston Scientific is recalling TENACIO Pump without InhibiZone, UPN 72404420, because of the potential for inflation or deflation performance issues or difficulties.

    Product
    TENACIO Pump without InhibiZone; UPN: 72404420;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2026·2025-10-22

    TENACIO pumps with InhibiZone recalled over inflation and deflation issues

    Boston Scientific is recalling 59 TENACIO Pump with InhibiZone units, UPN 72404429, because of the potential for inflation or deflation performance issues or difficulties.

    Product
    TENACIO Pump with InhibiZone; UPN: 72404429;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2026·2025-10-22

    CX preconnect pumps recalled over inflation and deflation performance issues

    Boston Scientific is recalling 2,288 CX Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0143-2026·2025-10-22

    Preconnect pump devices recalled over inflation and deflation performance issues

    Boston Scientific is recalling 172 CXR Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0140-2026·2025-10-22

    CX preconnect pumps without InhibiZone recalled over inflation deflation issues

    Boston Scientific is recalling CX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0131-2026·2025-10-22

    Carotid stent systems recalled because integrated filter may not fully open

    Contego Medical is recalling 568 Neuroguard IEP carotid stent systems because the integrated filter may not open, or may not fully open, during sheath retraction and filter knob operation.

    Product
    Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0144-2026·2025-10-22

    LGX preconnect pumps recalled over inflation and deflation performance issues

    Boston Scientific is recalling 490 LGX Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0141-2026·2025-10-22

    LGX preconnect pumps without InhibiZone recalled over inflation deflation issues

    Boston Scientific is recalling LGX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2567-2025·2025-10-01

    Medline Medical Convenience Kits with Defective Laryngoscope Handles

    Medline Industries is recalling specific medical convenience kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles because the light fails to illuminate as intended, potentially affecting resuscitation and airway management procedures.

    Product
    Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532; 3. DRAWER #4C ADULT, Kit Number ACC010671; 4. DRAWER #2, Kit Number ACC010728.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2568-2025·2025-10-01

    Automated Impella Controller units recalled for pump performance risk

    Abiomed is recalling specific Automated Impella Controllers with defective Pump Driver Circuit Assemblies that may cause decreased pump performance or pump stop. The defect triggers Impella Failure or Impella Stopped Controller Failure alarms.

    Product
    Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Package
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2605-2025·2025-10-01

    STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device recalled

    Ethicon LLC is recalling STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (Product Code SXPP2B400-11, Lot 104DBB) due to potential barb non-engagement that could affect surgical outcomes.

    Product
    STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2343-2025·2025-09-03

    Insulin pumps recalled over malfunction that stops insulin delivery and alerts

    Tandem t:slim X2 insulin pumps built with Revision A and B speakers may hit Malfunction 16, losing audible alerts and stopping insulin delivery. The FDA classified the action as Class I. 171,750 units are affected.

    Product
    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2171-2025·2025-07-30

    Stryker StrykeFlow irrigator with tip may leak solution into handpiece

    The Stryker StrykeFlow Disposable Suction/Irrigator with Disposable Tip is being recalled because irrigation solution may leak into the handpiece and battery pack, causing it to malfunction.

    Product
    Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2025·2025-07-30

    Stryker StrykeFlow suction irrigator may leak solution into the handpiece

    The Stryker StrykeFlow Disposable Suction/Irrigator is being recalled because irrigation solution may leak into the handpiece and battery pack, causing it to malfunction.

    Product
    Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2047-2025·2025-07-16

    Bravo CF capsule delivery devices may have misapplied adhesive causing malfunction

    The Bravo CF capsule delivery device is being recalled because misapplied adhesive may prevent the pH capsule attaching to the oesophagus or detaching from the delivery device. 128,202 units affected.

    Product
    Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2058-2025·2025-07-09

    Philips S5-1 Ultrasound Transducers Refurbished Beyond Useful Life

    Philips Ultrasound is recalling Philips S5-1 Transducers because they were refurbished beyond their useful life, which may affect device performance and safety.

    Product
    Philips S5-1 Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2025·2025-07-09

    Philips C9-5EC Ultrasound Transducer Devices Recalled

    Philips Ultrasound, Inc. is recalling Philips C9-5EC transducer devices that were refurbished beyond their useful life, which may affect device performance and safety.

    Product
    Philips C9-5EC Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2025·2025-07-09

    Medline IV Catheter Kits Recalled Over Needle Retraction Issue

    Medline is recalling 36 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN due to a potential needle retraction failure during insertion.

    Product
    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2000-2025·2025-07-02

    BD Insyte Autoguard BC Winged IV Catheter Needle Retraction Issue

    Becton Dickinson is recalling a specific lot of BD Insyte Autoguard BC Winged IV catheters (REF 382633, Lot 4222721) due to reports that the catheter needle may be slow to retract or fail to retract entirely.

    Product
    REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide