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.

226–250 of 1800

HighFDA (Devices)·Z-0566-2025·2024-12-04
Baxter MiniCap Extended Life PD Transfer Set Connector Separation Complaints
Baxter Healthcare is recalling the MiniCap Extended Life peritoneal dialysis transfer set due to complaints about female connector separation from the main body. The Class II recall affects 3,204 units distributed worldwide.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; 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-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
HighFDA (Devices)·Z-0548-2025·2024-12-04
Philips ST SENSE Breast Imaging Coil Recalled for Patient Safety Risk
Philips is recalling 5,231 units of the ST SENSE Breast Dx Coil nationwide due to a potential safety issue that may harm patients during breast imaging scans. No injuries have been reported.
Product
ST SENSE Breast Dx Coil
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0536-2025·2024-12-04
Philips Achieva TX Interventional Coil 3.0T Recalled for Patient Safety Risk
Philips recalls the Achieva TX Interventional Coil 3.0T (5,231 units) for a potential safety issue that may harm patients during MRI scan preparation or procedures.
Product
Achieva TX Interventional Coil 3.0T
Category
Medical Device
Distribution
Distributed nationwide
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
ModerateFDA (Devices)·Z-0523-2025·2024-12-04
Z-800WF Infusion Pumps Recalled for Software Incompatibility Issue
Zyno Medical LLC is recalling Z-800WF infusion pumps due to incompatibility between WiFi software and the pump's operating software. The affected units were distributed in eight U.S. states.
Product
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certi
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-0482-2025·2024-11-27
Medical Device Recall: Counterfeit Batteries in Plum Infusion Systems
Counterfeit CSB batteries are being used in Plum Infusion Systems. These unauthorized batteries fail to hold their charge and have not been tested for use with the pumps.
Product
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0473-2025·2024-11-27
Posi-Stop Injection Needles recalled for manufacturing debris blockage
Hobbs Medical is recalling Posi-Stop Injection Needles due to manufacturing debris that can block needle flow. Some units may contain debris in the inner sheath that prevents injection solutions from functioning properly.
Product
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0481-2025·2024-11-27
CAIRE FreeStyle Comfort portable oxygen concentrator battery recharge failure
Caire Inc. is recalling 26 CAIRE FreeStyle Comfort portable oxygen concentrators due to potential battery recharge failure. Affected units identified by serial number may not charge properly.
Product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0506-2025·2024-11-27
Z-800 Infusion System Recalled for Battery Depletion Risk
Zyno Medical is recalling 34,994 units of the Z-800 Infusion System due to battery depletion risk from self-discharge and parasitic leakage current. The battery may not retain charge despite continuous AC power, potentially affecting device operation.
Product
Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certifie
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0480-2025·2024-11-27
CAIRE FreeStyle Comfort Portable Oxygen Concentrator Battery Recharge Failure
Six CAIRE FreeStyle Comfort oxygen concentrators may fail to recharge their batteries, potentially affecting portable use of these medical devices. Caire, Inc. is recalling affected units worldwide.
Product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0290-2025·2024-11-20
Trilogy Evo O2 Ventilators Recalled for Potential Flow Sensor Malfunction
Philips Respironics recalled 24,249 Trilogy Evo O2 ventilators because in-line nebulizer configurations may allow aerosol deposits to accumulate on the device's flow sensor, potentially causing inaccurate flow measurements.
Product
Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pedi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0461-2025·2024-11-20
MEERA CL operating table may stop unexpectedly during surgical procedures
The MEERA CL operating table may experience error code 50037 on its IR-Hand Control, causing the table to stop mid-procedure. No injuries have been reported.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0351-2025·2024-11-20
Cystoscope Outer Sheath Recalled for Potential Laser Probe Damage
Olympus is recalling 738 units of the WA22810A Cystoscope Outer Sheath distributed nationwide due to potential damage to the laser probe tip during use with GreenLight Laser for BPH therapy. The manufacturer removed this compatibility claim from product instructions.
Product
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0372-2025·2024-11-20
Medtronic Recharger Kits Recalled for Potential Failure to Initiate Recharging
Medtronic is recalling 118 wireless recharger kits for implantable neurostimulators because they may fail to start a recharging session upon first use.
Product
Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep Bra
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0462-2025·2024-11-20
MEERA CL Operating Table Error Code 50037 Causes Unexpected Stoppage
The MEERA CL operating table may experience error code 50037, causing the table to unexpectedly stop during operation. This error occurs sporadically when controlled via an IR-Hand Control and may delay surgical procedures.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001B0
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0460-2025·2024-11-20
FDA Recalls MEERA CL Mobile Operating Tables for Unintended Movement Stops
Getinge Usa Sales Inc is recalling 112 MEERA CL mobile operating tables because error code 50037 may cause the table to stop moving unexpectedly when controlled via IR hand control, resulting in procedural delays.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0459-2025·2024-11-20
Getinge MEERA CL Mobile Operating Table Recalled for Intermittent Movement Errors
Getinge is recalling 52 MEERA CL mobile operating tables because an error code may cause the table to stop moving, potentially delaying surgical procedures.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0309-2025·2024-11-13
DeRoyal Surgical Procedure Pack Smoke Evacuation Pencil Recalled
DeRoyal is recalling surgical procedure pack products containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after buttons are released. The malfunction poses a risk of injury during surgical procedures.
Product
DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0307-2025·2024-11-13
DeRoyal Children's Surgical Pack Recalled for Smoke Pencil Malfunction
DeRoyal is recalling certain lots of children's surgical procedure packs due to reports that the included Stryker smoke evacuation pencil may activate without manual input or remain active after buttons are released.
Product
DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0229-2025·2024-11-06
Olympus Endoscopic Flushing Pump Recalled Due to Function Loss
Olympus is recalling the OFP-2 Endoscopic Flushing Pump due to intermittent loss of function caused by internal component connection failure. Approximately 445 units distributed nationwide are affected.
Product
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0264-2025·2024-11-06
Olympus Electrosurgical Generator ESG-410 Recalled for Audio Buffer System Error
Olympus Corporation recalls 279 units of its ESG-410 electrosurgical generator nationwide due to increased complaints of system error E1226 (Could not write to Audio Buffer) occurring during surgical procedures.
Product
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0192-2025·2024-10-30
Pressure Monitoring Kit Recalled for Manufacturing Defect and Malfunction
The medex TranStar 84in Single Monitoring Kit is being recalled due to manufacturing defects in its disposable pressure transducer. The defect may cause inaccurate pressure readings, interruption of monitoring, or inability to zero the device.
Product
medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0142-2025·2024-10-30
Internal Defibrillation Paddles Recalled for Cracks and Separation
Physio-Control is recalling sterilizable internal defibrillation paddles (LP20 and LP15 models) due to cracking and over-molding separation. The defects may prevent proper device function during critical cardiac emergency treatment.
Product
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Sync
Category
Medical Device
Distribution
Distributed nationwide