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.

201–225 of 1800

HighFDA (Devices)·Z-0993-2025·2025-01-29
Olympus Thunderbeat surgical instrument probe tips breaking and detaching
Olympus is recalling Thunderbeat surgical instruments due to probe tip damage, breaking, and pad detachment.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5000687 Software Version: N/A Product Description: Thunderbeat instrument is a
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0827-2025·2025-01-22
VISIONIST CRT-P Pacemakers Recalled Due to Battery Impedance Risk
Certain VISIONIST CRT-P pacemakers with latent high battery impedance may initiate Safety Mode unexpectedly during normal operations. Manufactured before September 2018, 156,329 units were distributed worldwide.
Product
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0822-2025·2025-01-22
ACCOLADE DR Pacemakers Recalled for Unintended Safety Mode Activation
Boston Scientific is recalling ACCOLADE DR Pacemakers built before September 2018 due to risk of unintended Safety Mode activation caused by battery impedance issues. The devices may enter Safety Mode during normal telemetry operations.
Product
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0824-2025·2025-01-22
ESSENTIO DR Pacemakers May Malfunction Due to Battery Impedance Issue
Boston Scientific is recalling certain ESSENTIO DR Pacemakers manufactured before September 2018 due to latent battery impedance that may cause Safety Mode malfunction during normal operations.
Product
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0841-2025·2025-01-22
Hillrom Temperature Management Controllers May Experience Power-On Self-Test Error
Hillrom Temperature Management Controller Model 2083516 may experience a power-on self-test error code 'EA POST' during startup. The recall affects 77 units distributed worldwide.
Product
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0904-2025·2025-01-22
Medtronic NanoCross Elite PTA Catheter Recall Due to Balloon Deflation
Medtronic's NanoCross Elite PTA catheters in certain lots may not deflate properly during use. The FDA is recalling 5,189 units due to potential in-vivo balloon deflation issues.
Product
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0839-2025·2025-01-22
Augustine Surgical temperature management controllers may experience power-on self-test error
Augustine Surgical temperature management controllers (Models WC71, WC77, and MP 2083516) may experience a power-on self-test error code. Seventeen units have been recalled worldwide.
Product
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0846-2025·2025-01-22
Stryker Blueprint Glenoid Pin Guide May Disassemble During Shoulder Surgery
The metal tube of the Stryker Blueprint Glenoid Pin Guide may disassemble from the plastic handle. This can prevent the guidance system from detecting the device, potentially prolonging surgery or requiring a switch to conventional surgical methods.
Product
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-0763-2025·2025-01-15
Large Volume Pump model LVP-0004 recalled for potential pneumatic valve failure
Fresenius Kabi is recalling 1,520 Ivenix infusion pumps (model LVP-0004) due to potential pneumatic valve failure that may stop active infusions or prevent pump operation. Affected units were distributed to healthcare facilities in six U.S. states.
Product
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0774-2025·2025-01-08
SynchroMed II and III Implantable Pumps Recalled for Software Issues
Medtronic has recalled 3,981 SynchroMed implantable pumps worldwide due to software issues in application version 2.x used to program the devices.
Product
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0770-2025·2025-01-08
Auryon Laser Atherectomy System Recalled for Activation Failure
Angiodynamics is recalling 138 units of the Auryon atherectomy laser system due to potential failure to advance to activation mode during use. This malfunction could cause procedural delays or interruptions.
Product
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0746-2025·2025-01-01
BD FACSLyric Flow Cytometer Power Supply May Fail During Use
BD FACSLyric flow cytometers are recalled for power supply failures that may prevent the device from powering on, risking specimen loss and potential respiratory effects from fume inhalation.
Product
Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cy
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0656-2025·2024-12-25
Surgical Bipolar Pencil Recall: Risk of Tube Breakage During Eye Surgery
Kirwan Surgical Products is recalling disposable bipolar surgical pencils used in eye surgery because the outer stainless-steel tube may break or detach during use.
Product
Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0690-2025·2024-12-25
K-Systems T47 Warming Plate May Exceed Set Temperatures
CooperSurgical recalls K-Systems T47 Warming Plates because temperature may exceed the desired set value, potentially affecting biological materials. The device alarms appropriately when this occurs.
Product
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0657-2025·2024-12-25
Ambler Surgical Bipolar Pencil recalled for outer tube structural failure
Kirwan Surgical Products is recalling the Ambler Surgical Bipolar Pencil 25 Gauge Straight (Model PD7226) because the outer stainless-steel tube may break or detach during use. 4,470 units worldwide are affected.
Product
Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area durin
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0689-2025·2024-12-25
K-Systems T47 Warming Plate may exceed desired temperatures
The K-Systems T47 Warming Plate has a temperature control defect where warming surfaces may exceed desired set temperatures. CooperSurgical is recalling 22 affected units distributed to fertility clinics.
Product
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0700-2025·2024-12-25
HOT DOG Temperature Management Controller Instructions for Use Update
Augustine Temperature Management is updating instructions for HOT DOG Patient Warming Controllers (Models WC71, WC71R) regarding a power-on self-test error code. The update affects 135 units distributed in the US and Canada.
Product
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0631-2025·2024-12-11
Medline Convenience Kits Recalled Due to Defective Component
Medline Industries is recalling 70 convenience kits containing SafeAir Smoke Evacuation Pencil components that were subsequently recalled by Stryker. The affected product types are General Endoscopy Pack and Endo Bladder Pack.
Product
MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0582-2025·2024-12-11
Cook Medical HEMO-7-EU Hemospray Devices Recalled for Activation Knob Defect
Cook Medical HEMO-7-EU Hemospray devices are being recalled because the activation knob may crack or break during use due to manufacturing defects. The affected devices were distributed to Argentina, Brazil, and Israel.
Product
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0562-2025·2024-12-04
Baxter MiniCap Peritoneal Dialysis Sets Recalled for Connector Separation
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to increasing reports of the female connector separating from the main body. The defect affects 62,718 units distributed worldwide.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0572-2025·2024-12-04
TriALTIS Torque Limiter Ratchet Recalled for Excessive Torque Output
Gauthier Biomedical is recalling the TriALTIS TORQUE LIMITER due to an out-of-specification component that may cause the device to produce higher torque output than intended. The recall affects 160 units.
Product
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0569-2025·2024-12-04
Baxter MiniCap Extended Life PD Transfer Set—Connector Separation Recall
Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to reports of the female connector separating from the transfer set body. The defect may compromise dialysis treatment safety.
Product
Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0514-2025·2024-12-04
MEDLINE Neuraxial Kit Connectors May Prevent Catheter Insertion
MEDLINE has recalled 360 units of its Neuraxial Kit (Lot 23KLA330) because connectors may not fully open, potentially preventing catheters from being inserted as intended. Healthcare facilities should discontinue use and contact MEDLINE.
Product
MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0521-2025·2024-12-04
Surgical forceps and scissors handles recalled due to pin detachment
MicroSurgical Technology is recalling MST Duet Reusable Handles for surgical forceps and scissors due to pin detachment risk. Six units distributed in the US; 18 internationally.
Product
Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable han
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0508-2025·2024-12-04
Medline Nexus Catheter Connectors May Fail to Open Properly
Medline recalls 1,975 NEXUS catheter connectors that may not fully open, preventing proper catheter insertion. Affected units were distributed nationwide and internationally.
Product
MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector
Category
Medical Device
Distribution
Distributed nationwide