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.

276–300 of 1800

  • HighFDA (Devices)·Z-3142-2024·2024-09-25

    Alaris Pump Module 8100 Recalled for Bent Connector That May Disable Device

    CareFusion is recalling approximately 192,964 Alaris Pump Module Model 8100 infusion pumps that may have bent female connectors preventing device operation and delaying patient treatment.

    Product
    Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3139-2024·2024-09-25

    Alaris PCA Pump Module May Have Defective IUI Connector

    CareFusion recalls approximately 10,460 Alaris PCA Module Model 8120 infusion pumps worldwide due to potentially bent female IUI connectors that may prevent proper device operation and delay treatment initiation.

    Product
    Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3141-2024·2024-09-25

    Alaris Syringe Module Model 8110 Infusion Pumps Recalled for Bent Connectors

    CareFusion's Alaris Syringe Module Model 8110 infusion pumps are being recalled because affected units may have bent female connectors that can prevent device operation and delay infusions. Approximately 20,145 units have been distributed worldwide.

    Product
    Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3140-2024·2024-09-25

    Alaris EtCO2 Module Model 8300 Recalled Due to Bent Connector

    CareFusion 303, Inc. recalls 180 Alaris EtCO2 Module Model 8300 units with potentially bent female connectors that may prevent device operation, risking delays in infusion and monitoring.

    Product
    Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3138-2024·2024-09-25

    Infusion Pump Alaris System PC Unit 8015 Recalled for Bent Connector

    CareFusion's Alaris System PC Unit Model 8015 infusion pumps are being recalled due to a bent female IUI connector affecting over 125,000 devices. The defect may prevent the device from operating properly or delay infusion or monitoring startup.

    Product
    Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3108-2024·2024-09-18

    Medline Recalls Semi-Rigid Suction Liners Due to Suction Loss

    Medline Industries is recalling 19 units of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: DENTAL, Pack Number DYNJ909451A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3113-2024·2024-09-18

    Medline Recalls Semi-Rigid Suction Liners Due to Suction Loss

    Medline is recalling specific lots of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR BREAST, Pack Number DYNJ908104B; b) PLASTIC MAJOR, Pack Number DYNJ908106B; c) ABDOMINOPLASTY W/LIPO SUCTION, Pack Number DYNJ909946; d) PLASTIC, Pack Number DYNJ909951
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3116-2024·2024-09-18

    Medline Semi-Rigid Suction Liners Recalled for Potential Suction Loss

    Medline is recalling 1,800 units of semi-rigid suction liners used in anesthesia turnover kits due to reported adverse events related to potential loss of suction during intermittent use. Affected lots were manufactured between September and November 2023.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYNJAA10338J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3117-2024·2024-09-18

    Medline Suction Liners Recalled Due to Potential Suction Loss

    Medline Industries is recalling 134 units of semi-rigid suction liners due to potential loss of suction during intermittent use. The affected kits were distributed worldwide including the US, Canada, and Panama.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS CHILD, Pack Number DYNJ907829B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3105-2024·2024-09-18

    Medline semi-rigid suction liners recalled due to potential suction loss

    Medline Industries is recalling specific lots of semi-rigid suction liners due to potential loss of suction or low suction during use. About 1.25 million units distributed in the US, Canada, and Panama are affected.

    Product
    Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION LINER WITH TUBING, REF OR526K; c) SEMI RIGID SUCTION LINER WITH TUBING, REF OR527K; d) SEMI RIGID SUCTION LINER WITH TUBING, REF OR529K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3124-2024·2024-09-18

    Blood Pressure Module Fails to Record or Alarm in Hemodialysis Machines

    Fresenius hemodialysis machines with BPM3 blood pressure modules may fail to record measurements and will not alarm if cuff tubing is kinked. About 3,718 affected units in the US and Canada could result in undetected blood pressure changes during treatment.

    Product
    Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3073-2024·2024-09-18

    Medtronic InterStim Handset May Fail to Pair with Communicator

    Medtronic is recalling 211 InterStim Smart Programmer handsets that may not complete the pairing process with the communicator during initial setup.

    Product
    Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3112-2024·2024-09-18

    Medline Suction Liners Recalled Due to Potential Loss of Suction

    Medline is recalling 1,616 units of semi-rigid suction liners (ENDO KIT, pack numbers DYKE1350D and DYKE1514B) manufactured September to November 2023 that may lose or provide reduced suction during use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2692-2024·2024-09-04

    FreeStyle Libre 3 Sensors Recalled for Inaccurate Glucose Readings

    FreeStyle Libre 3 sensors may report falsely high glucose levels, causing users to over-dose insulin and miss dangerous low blood sugar episodes. Abbott has recalled 8,174 units.

    Product
    FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2760-2024·2024-09-04

    Medline procedural kits recalled for syringe leaks and breakage

    Medline procedural kits contain plastic syringes with leaks and breakage that may pose health risks. The affected kits are used for delivery procedures and distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR OB DELIVERY , Pack Number DYNJ908583; 3) SR OB DELIVERY , Pack Number DYNJ908583A; 4) VAG DELIVERY, Pack Number DYNJ909097
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2718-2024·2024-09-04

    Nanoplasty 3D Bunion Implant System Recalled for Mechanical Failure Risk

    Treace Medical Concepts is recalling its Nanoplasty 3D Bunion Implant (Model SK57) nationwide due to potential mechanical failures where locking screws may strip or fail to seat properly. No injuries have been reported.

    Product
    Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2448-2024·2024-08-21

    Plum A+ and Plum A+3 Infusion Pump Batteries Recalled for Capacity Loss Defect

    ICU Medical is recalling Plum A+ and Plum A+3 infusion pump batteries due to a manufacturing defect that may cause premature capacity loss and reduced runtime. Approximately 14,744 units were distributed worldwide.

    Product
    Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2447-2024·2024-08-21

    Plum 360 Infusion Battery Recall Due to Manufacturing Defect

    ICU Medical is recalling Plum 360 Infusion System replacement batteries due to a manufacturing defect that may cause loss of capacity and decreased runtime earlier than expected. Approximately 11,961 units were distributed worldwide.

    Product
    Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusi¿n Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Inf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2564-2024·2024-08-21

    FDA recalls Merit Medical convenience kits due to defective syringes

    Merit Medical convenience kits containing plastic syringes are recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected kits are used for vascular and cardiac procedures.

    Product
    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K09-01734L K09-02040C K09-02683F K09-02804B K09-03844F K0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2420-2024·2024-08-14

    CADD-Solis VIP Ambulatory Infusion Pump Class I Recall

    Smiths Medical is recalling CADD-Solis VIP Model 2110 infusion pumps in a Class I action affecting units worldwide.

    Product
    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of in
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2421-2024·2024-08-14

    Smiths Medical CADD-Solis VIP Ambulatory Infusion Pumps Recalled Worldwide

    Smiths Medical is recalling CADD-Solis VIP ambulatory infusion pumps (models 21-2120, 21-2125, 21-2127) worldwide. The FDA has classified this as a Class I recall.

    Product
    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies t
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2479-2024·2024-08-14

    GE SIGNA Prime MR system can exceed RF safety limits in Low SAR mode

    GE Medical Systems is recalling 72 SIGNA Prime MR imaging systems worldwide. Under specific imaging conditions, the systems can exceed prescribed radiofrequency safety limits, potentially causing MR conditional implants to overheat.

    Product
    SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2462-2024·2024-08-14

    GE SIGNA Premier MRI system software overheating risk to implants

    GE Medical Systems is recalling 404 SIGNA Premier MRI systems worldwide due to a software issue where radiofrequency energy can exceed prescribed safety limits during specific imaging sequences, potentially overheating MR-conditional implants.

    Product
    SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2530-2024·2024-08-14

    Baxter SIGMA Spectrum Infusion Pump recall due to inadequate pre-release testing

    Baxter Healthcare is recalling the SIGMA Spectrum Infusion Pump (Serial 2158913) distributed nationwide in Florida. The recall is due to improperly performed testing procedures prior to release, which may affect device function.

    Product
    Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2476-2024·2024-08-14

    GE SIGNA MR360 MRI System Software Defect May Overheat Implants

    GE SIGNA MR360 MRI systems with software versions SV25.5 or SV25.6 may exceed prescribed RF exposure limits in certain scan configurations, potentially overheating MR-conditional implants. The recall affects 81 units worldwide.

    Product
    SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states