Hazard

Device Malfunction recalls

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

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 877

HighFDA (Devices)·Z-1080-2026·2026-01-21
Bone Cement Ampoules May Break or Fail to Break Properly
Heraeus Medical is recalling PALACOS R pro bone cement due to ampoule breakage within the device system. If ampoules don't break properly, appropriate cement cannot be formed for use.
Product
Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable fo
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1049-2026·2026-01-21
Medline IV Administration Kits Recalled for Check Valve Sticking Risk
Medline is recalling IV administration kits containing B. Braun components due to check valve defects that may become stuck. The kits were distributed nationwide and used in anesthesia procedures.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972096014B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1053-2026·2026-01-21
Medline IV Administration Sets Recalled for Stuck Check Valves
Medline Industries is recalling 33 units of IV and pump administration sets due to check valve components that may become stuck in open or closed positions, potentially affecting fluid delivery.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1062-2026·2026-01-21
Philips Allura Xper FD10C Medical Imaging Systems Cooling Drip Tray Installation Issue
Philips is recalling 38 Allura Xper FD10C medical imaging systems in which the cooling unit drip tray may not be properly installed, potentially allowing coolant to contact electrical components and cause system shutdown.
Product
Product Name: Allura Xper FD10C; Model number: 722001;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1001-2026·2026-01-14
Organ recovery kit unsuitable for organ transplant purposes
The Halyard organ recovery kit was recalled because the devices are unsuitable for organ transplant.
Product
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1029-2026·2026-01-14
Pressio 2 ICP Monitor Recalled for Unexpected Rebooting
Sophysa is recalling 105 units of the Pressio 2 ICP Monitoring System due to customer complaints of unexpected rebooting. The malfunction could interrupt critical patient monitoring.
Product
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0996-2026·2025-12-31
Restore Clinician Programmer App reset message may prevent therapy resumption
A software issue in the Restore Clinician Programmer Application can prevent therapy from resuming, causing pain recurrence. Affected devices worldwide may require surgical replacement.
Product
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E P
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0592-2026·2025-12-17
FDA Recalls Draeger ErgoStar CM 55 Airway Connectors for Cracking
Draeger's ErgoStar CM 55 airway connectors are being recalled due to cracks forming in the catheter mount hose. The defect affects respiratory connectivity in mechanical ventilation systems used for critically ill patients.
Product
ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-0912-2026·2025-12-17
Hemodialysis System Surdial DX Fastener Loosening Defect Recall
Nipro Medical Corporation is recalling Hemodialysis System Surdial DX units due to a screw that may loosen or fall out. Affected systems were distributed nationwide. Patients should contact their healthcare provider immediately.
Product
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0853-2026·2025-12-10
IntelliVue MP40 monitors subject to recall due to potential alarm failure
Philips is recalling approximately 1.9 million IntelliVue MP40 patient monitors that may fail to sound alarms. Affected units were distributed worldwide to healthcare facilities.
Product
IntelliVue MP40. Product Number: M8003A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0863-2026·2025-12-10
Philips IntelliVue MX450 patient monitor may fail to alarm
Philips has recalled 1,913,441 IntelliVue Patient Monitor MX450 units worldwide due to a potential issue where monitors may not alarm on critical patient conditions.
Product
IntelliVue Patient Monitor MX450. Product Number: 866062.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0855-2026·2025-12-10
IntelliVue MP60 Patient Monitor Alarm Failure Class II Recall
Philips is recalling IntelliVue MP60 patient monitors due to a potential alarm failure. Approximately 1.9 million units distributed worldwide may fail to issue critical patient alerts.
Product
IntelliVue MP60. Product Number: M8005A.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0570-2026·2025-12-03
Olympus Ligating Device Recalled Due to Loop Release Failure
Olympus is recalling the HX-400U-30 ligating device used in endoscopy procedures because the nylon loop may fail to release properly from patient anatomy. The recall affects 7,803 units distributed throughout the United States.
Product
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0650-2026·2025-12-03
IV Administration Sets Pose Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling 6,650 IV Administration Sets due to potential backflow of medication into primary containers and inability to prime. The issue could compromise medication delivery in patients.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD SET CARESITE 127 IN.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0527-2026·2025-11-26
Medline Surgical Kits with Defective Smoke Evacuation Pencils Recalled
Medline Industries is recalling 570 surgical kits containing SafeAir Smoke Evacuation Pencils that may activate without user input when plugged in or remain active after buttons are released.
Product
MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST PACK, REF DYNJ44848M; 5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 6) VAGINA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0524-2026·2025-11-26
Medline Surgical Smoke Evacuation Pencils Recalled for Unintended Activation
Medline Industries is recalling convenience kits containing SafeAir Smoke Evacuation Pencils due to potential unintended activation or failure to deactivate, affecting 2844 kits distributed nationwide.
Product
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0523-2026·2025-11-26
Medline Smoke Evacuation Surgical Pencils Recalled for Unintended Activation Risk
Medline Industries recalls surgical smoke evacuation pencils due to potential for unintended activation when plugged in or failure to deactivate after use, affecting 424 kits nationwide.
Product
MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0526-2026·2025-11-26
Medline Surgical Kits Recalled for Smoke Evacuation Pencil Activation Risk
Medline is recalling 11,032 surgical kits containing SafeAir Smoke Evacuation Pencils due to a potential malfunction risk. The pencils may activate without user input when plugged into a power source or remain active after buttons are released.
Product
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D; 5) C-SECTION PACK-LF, REF DYNJ0536924U; 6) C-SECTION PACK-LF, REF DYNJ0551169V; 7) C-SECT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0513-2026·2025-11-26
Medline Convenience Kits with Smoke Evacuation Pencils Recalled for Unintended Activation
Medline is recalling 5,133 convenience kits containing SafeAir Smoke Evacuation Pencils that may activate without manual input or remain active after buttons are released. The nationwide recall includes surgical kits for cardiovascular and other procedures.
Product
MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0458-2026·2025-11-19
Eterna SCS Implantable Pulse Generator Model 32400 communication loss
Abbott Medical recalls the Eterna SCS Implantable Pulse Generator Model 32400 due to potential loss of communication with the Clinician Programmer and Patient Controller.
Product
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0485-2026·2025-11-19
Covidien Signia Surgical Device Recalled for Manufacturing Defect
Covidien is recalling 3263 units of its Signia vascular surgical device due to a manufacturing defect in the cover tube press. The defect could cause internal component movement during firing, potentially leading to uncontrolled motion during use.
Product
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0478-2026·2025-11-19
Virata Polyaxial Spinal Screws recalled for failing to meet performance standards
Orthofix U.S. LLC is recalling Virata Polyaxial Screws used in spinal fixation systems because they do not meet required performance standards. Affected units were distributed to healthcare facilities in California, North Carolina, and Texas.
Product
Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030. 2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035. 3. POLYAXIAL SCREW, CC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0343-2026·2025-11-05
ICU Medical ChemoLock Vial Spike: Potential Weld Failure and Leak Risk
ICU Medical is recalling ChemoLock Universal Vented Vial Spikes due to potential weld failure in the port that could cause leakage during use. The defect affects approximately 16,850 units distributed nationwide and internationally.
Product
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0365-2026·2025-11-05
ChemosafeLock Vial Adapter port weld may separate and cause drug leakage
ICU Medical is recalling ChemosafeLock Vial Adapters due to a port weld defect that may separate or break during use, potentially causing drug leakage. Approximately 202,900 units are affected worldwide.
Product
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0136-2026·2025-10-29
Automated Impella Controller units recalled due to purge system failures
Abiomed's Automated Impella Controller may experience purge pressure issues due to purge retainer failures. Approximately 9,177 units distributed worldwide are affected. Patients should contact their healthcare provider.
Product
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-00
Category
Medical Device
Distribution
Distributed nationwide