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.

601–625 of 1800

HighFDA (Devices)·Z-1989-2023·2023-06-28
Single use hemostatic clips recalled for clip deployment and mechanical failures
Olympus Corporation recalls QuickClip Pro hemostatic clips (13,707 units) nationwide due to device deployment failures. Complaints include clip arms failing to open or close and premature tissue detachment during clinical procedures.
Product
Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1979-2023·2023-06-28
Hemospray Endoscopic Hemostat Recalled for Powder Adhesion Risk
Wilson-Cook Medical is recalling Hemospray Endoscopic Hemostat units (14,877 devices, US and worldwide distribution) because powder can adhere to the endoscope tip, potentially making removal difficult or impossible.
Product
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1718-2023·2023-06-28
Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
Medtronic implantable cardiac defibrillators may deliver reduced or no energy during defibrillation therapy due to a feedthrough defect. Approximately 11,239 devices distributed worldwide are affected.
Product
ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1990-2023·2023-06-28
Hemostatic Clip Device Recalled Due to Deployment Failures
Olympus recalls QUICKCLIP PRO hemostatic clips nationwide due to reported malfunction during clinical procedures, where clips fail to open, close, or detach from tissue as intended.
Product
Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1754-2023·2023-06-28
Implantable Cardiac Defibrillators May Deliver Reduced Energy Output
Certain Medtronic cardiac defibrillators may deliver reduced or no energy during high voltage therapy. No injuries or deaths have been reported.
Product
CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1763-2023·2023-06-28
Implantable Cardiac Defibrillators at Risk of Therapy Delivery Failure
Medtronic implantable defibrillators may fail to deliver therapy due to a feedthrough defect. 2,173 affected units were distributed nationwide and worldwide.
Product
CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1980-2023·2023-06-28
V-Sign Sensor 2 May Experience Out-of-Box Failure Due to Software Configuration
The V-Sign Sensor 2, a component of the Sentec Digital Monitoring System, may fail out of the box due to improper software mode configuration after recalibration. Approximately 11 units were distributed in select U.S. states.
Product
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1968-2023·2023-06-21
Tearaway Introducer Kit Recalled Due to Potential Connector Defect
Galt Medical Corporation is recalling Tearaway Introducer Kits due to potential cracking or dislodging of the luer connection during use, which can render the device unusable and require replacement.
Product
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1909-2023·2023-06-21
FDA Recalls Aspira Peritoneal Drainage Catheter Insertion Tray for Valve Failure
Merit Medical Systems recalls Aspira Peritoneal Drainage Catheter Insertion Tray due to a potential valve failure that could prevent necessary fluid drainage.
Product
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1825-2023·2023-06-21
Philips Tempus LS-Manual Defibrillator pacing failure due to communication error
A communication failure in the Philips Tempus LS-Manual Defibrillator may prevent pacing delivery. The device displays an error message and potentially becomes ineffective, affecting approximately 1,147 units distributed nationwide.
Product
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1689-2023·2023-06-14
TREO Abdominal Stent-Graft Label Does Not Match Actual Device Size
Bolton Medical is recalling the TREO Abdominal Stent-Graft System because the carton label may not match the actual stent-graft size inside. Implanting the wrong size stent-graft could result in surgical complications.
Product
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1627-2023·2023-06-07
Medical X-Ray Imaging System Recalled for Device Malfunction
The CS 9600 X-ray imaging system manufactured by Trophy SAS has been recalled worldwide due to failure to function as intended and non-conformance to design specifications. Approximately 895 units are affected.
Product
CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿of¿the¿dento-maxilofacial,¿ENT¿(Ear,¿Nose¿and¿Throat),¿cervical¿spine¿and¿wrist¿regions¿at¿the¿direction¿of¿healthcare¿professionals¿as¿diagnostic¿support¿for¿pediatric¿a
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1618-2023·2023-05-31
Pediatric Ventricular Assist Device Blood Pumps Recalled for Potential Membrane Disruption
BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device Blood Pumps due to potential disruption in triple-layer membranes. The 335 affected units were distributed to multiple US states and Canada.
Product
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was r
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-1616-2023·2023-05-31
Olympus Fine Needle Aspiration Needles Recalled for Angle Non-Conformance
Olympus is recalling 1,297 boxes of fine needle aspiration needles due to a manufacturing defect where the needle angle does not meet specifications, resulting in slight resistance during needle advancement and retraction.
Product
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1615-2023·2023-05-31
ViziShot 2 Aspiration Needle recalled for manufacturing angle defect
ViziShot 2 Aspiration Needles are being recalled because the needle angle does not meet specifications and remains unbent, causing resistance during use. No illnesses or injuries have been reported.
Product
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1565-2023·2023-05-24
Replacement Battery in Plum 360 Infusion System Recalled for Capacity Loss
ICU Medical Inc is recalling 28,656 replacement batteries used in the Plum 360 Infusion System due to a manufacturing defect that causes premature capacity loss and decreased runtime. Affected units are distributed worldwide.
Product
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1566-2023·2023-05-24
Plum A+ & A+3 Infusion System Batteries Recalled Due to Manufacturing Defect
ICU Medical Inc is recalling replacement batteries used in Plum A+ and A+3 infusion pump systems. A manufacturing defect may cause batteries to lose capacity earlier than expected.
Product
Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1592-2023·2023-05-24
WATCHDOG Hemostasis Valve Kit recalled for insertion tool occlusion
Boston Scientific recalls 1,300 WATCHDOG Hemostasis Valve Kits due to insertion tool occlusion that prevents guidewire passage. Affected units were distributed worldwide.
Product
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Category
Medical Device
Distribution
0 states
SevereCPSC·23207·2023-05-18
BQQZHZ Combination Smoke and Carbon Monoxide Detectors May Fail to Alert
The CPSC is warning consumers to stop using BQQZHZ combination smoke and carbon monoxide detectors immediately because they can fail to alert to hazardous smoke and fire. About 25,000 units sold on Amazon.com are affected.
Product
BQQZHZ Combination Smoke and Carbon Monoxide Detectors
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1577-2023·2023-05-17
STA Compact Max analyzer firmware bug causes inaccurate test results
A firmware bug in Diagnostica Stago's STA Compact Max analyzer causes intermittent shortened coagulation times and frequent technical errors that produce inaccurate lab test results. Five units were distributed to clinical laboratories nationwide.
Product
STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1569-2023·2023-05-17
Aesculap Caiman Articulating Surgical Device Recalled for Loose Spring
Aesculap Caiman Articulating electrosurgical devices are being recalled because a spring may become loose and fall out during surgery, potentially entering the patient's body.
Product
Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0568-2023·2023-05-17
Calcitonin Salmon Nasal Spray Recalled for Glass Particle Defect
Apotex Corp. recalls Calcitonin Salmon nasal spray (82,375 bottles) nationwide due to a glass splinter entrapped in the pump mechanism. The defect renders the nasal spray inoperable.
Product
CALCITONIN SALMON — CALCITONIN SALMON (CALCITONIN SALMON)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1556-2023·2023-05-10
VITROS 5600 system pack opener assembly may not function properly
The MicroTip Pack Opener Assembly on VITROS 5600 systems may fail to remove or replace pack caps properly, making packs unusable and delaying clinical test results. Approximately 4,895 units were distributed.
Product
VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnosti
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1422-2023·2023-05-03
Surgical forceps may fail to open when endoscope shaft is bent
Richard Wolf surgical forceps may fail to open when used during endoscopic procedures if the endoscope shaft becomes bent. Approximately 838 units are affected worldwide.
Product
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1425-2023·2023-05-03
Surgical forceps may fail to open during endoscopic procedures
Richard Wolf surgical forceps may fail to open when the endoscope shaft is bent. Affected units distributed worldwide; users should check lot numbers and discontinue use if affected.
Product
FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685
Category
Medical Device
Distribution
Distributed nationwide