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.

1076–1100 of 1800

HighFDA (Devices)·Z-1272-2019·2019-05-22
Ethicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers
Ethicon Endo-Surgery is recalling 434,614 Endoscopic Curved Intraluminal Staplers (Model ECS25A) because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1116-2019·2019-05-01
Edwards Lifesciences Recalls Fogarty Dilation Atrioseptostomy Catheters
Edwards Lifesciences is recalling Fogarty Dilation Atrioseptostomy Catheters due to reports of balloon fragmentation or detachment and difficulty deflating the balloon after deployment.
Product
Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an ac
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1209-2019·2019-05-01
Fresenius Kabi CATSmart Autotransfusion Device Recalled for Tubing Wear Risk
Fresenius Kabi is recalling 342 CATSmart autotransfusion devices because tubing may contact the washing chamber, causing wear or puncture.
Product
Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Par
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1132-2019·2019-04-24
Wilson-Cook Recalls Acusnare Polypectomy Snares Due to Loop Retraction Issues
Wilson-Cook Medical Inc. is recalling 34,456 Acusnare Polypectomy Snares because the snare loop may not completely retract or may misshape.
Product
Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1110-2019·2019-04-17
Procept Biorobotics Recalls AquaBeam Handpieces Due to Potential Internal Leaks
Procept Biorobotics is recalling 214 AquaBeam Handpieces because a micro-crack in a weld joint may cause an internal leak, potentially delaying or preventing the completion of medical procedures.
Product
AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting f
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1100-2019·2019-04-17
Edwards IntraClude Intra-Aortic Occlusion Device Recalled for Inter-Lumen Leak
Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to a reported leak between the cardioplegia and pressure lumens.
Product
Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1067-2019·2019-04-03
Philips MX40 Wearable Monitor Batteries Recalled for Manufacturing Defect
Philips North America is recalling 40 lithium-ion rechargeable batteries for the MX40 Wearable Monitor due to a manufacturing defect that may affect monitor operation.
Product
Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0983-2019·2019-03-13
Maquet Cardiovascular Recalls AXIUS Blower Mister Due to CO2 Flow Issues
Maquet Cardiovascular is recalling AXIUS Blower Mister devices because a potential lack of carbon dioxide flow may cause procedural delays during off-pump coronary artery bypass surgery.
Product
AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0863-2019·2019-03-06
Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillator Service Kits
Physio-Control is recalling 682 LIFEPAK 15 Monitor/Defibrillator service kits because they may lock up after delivering a shock, leaving the monitor display blank.
Product
LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/de
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0866-2019·2019-03-06
Zimmer Biomet Recalls Vitality Spinal Fixation Set Screws
Zimmer Biomet is recalling Vitality Shear-off Set Screws because they do not thread properly with mating components due to a manufacturing issue.
Product
Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0846-2019·2019-02-27
Teleflex Recalls Pilling Cooley Sump-Suction Tubes Due to Missing Tip
Teleflex Medical is recalling 80 units of Pilling Cooley Sump-Suction Tubes because a missing internal tip prevents the device from functioning as intended.
Product
Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0809-2019·2019-02-20
Medtronic SENSIA Dual Chamber Pacemaker Recall for Circuit Error
Medtronic is recalling SENSIA dual chamber pacemakers due to a potential circuit error that may affect device functionality when programmed to specific modes.
Product
Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0806-2019·2019-02-20
Medtronic Adapta Dual Chamber Pacemaker Recall for Circuit Error
Medtronic is recalling specific Adapta, Versa, and Sensia dual chamber pacemakers due to a circuit error that may affect device functionality.
Product
Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number ADDRS1 (g) Model Number ADVDD01
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0808-2019·2019-02-20
Medtronic Pacemaker Recall: Circuit Error Affects Dual Chamber Functionality
Medtronic is recalling 7,469 dual chamber pacemakers worldwide due to a circuit error that may affect device functionality when programmed to specific modes.
Product
Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0810-2019·2019-02-20
Medtronic Sphera DR MRI SureScan Pacemakers Recalled for Circuit Error
Medtronic is recalling specific Sphera DR MRI SureScan pacemakers worldwide due to a circuit error that may affect device functionality when programmed to dual chamber mode.
Product
Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0812-2019·2019-02-20
Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode
Medtronic is recalling specific dual chamber pacemakers due to a circuit error that may affect device functionality when programmed to atrial-sensing mode.
Product
vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0811-2019·2019-02-20
Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode
Medtronic is recalling specific Versa, Adapta, and Sensia pacemakers distributed worldwide from 2017 to 2019 due to a potential circuit error that may affect device functionality.
Product
Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0807-2019·2019-02-20
Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode
Medtronic is recalling specific dual chamber pacemakers distributed worldwide between 2017 and 2019 due to a potential circuit error affecting device functionality.
Product
Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0779-2019·2019-02-06
Haemonetics Recalls Cell Saver Elite Processing Kits Due to Leakage Risk
Haemonetics is recalling 4,576 Cell Saver Elite Processing Kits because the 70ml centrifuge bowl may leak during cell salvage processing.
Product
Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a resu
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0727-2019·2019-01-23
Volcano Visions PV .035 Digital IVUS Catheter Recalled for Guidewire Issue
Volcano Corporation is recalling Visions PV .035 Digital IVUS Catheters because the guidewire may not pass through the y-port.
Product
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cyli
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0726-2019·2019-01-23
Volcano Visions PV .035 Digital IVUS Catheter Recall for Guidewire Issue
Volcano Corporation is recalling Visions PV .035 Digital IVUS Catheters because the guidewire may not pass through the y-port.
Product
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cyli
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0696-2019·2019-01-16
Ethicon Recalls PROXIMATE PPH Hemorrhoidal Circular Staplers Due to Missing Washer
Ethicon Endo-Surgery Inc is recalling 15,264 units of PROXIMATE PPH Hemorrhoidal Circular Staplers because they may be missing a washer, potentially causing bleeding or soft tissue injury during use.
Product
PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0619-2019·2018-12-26
ICU Medical Recalls Sapphire Epidural Sets Due to Occlusion Alarms
ICU Medical is recalling 31,050 units of Sapphire Epidural Sets due to reports of distal occlusion alarms during use.
Product
SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0613-2019·2018-12-26
Tosoh AIA-360 Analyzer Recalled for Table Home Sensor Malfunction
Tosoh Bioscience Inc is recalling 438 AIA-360 Analyzers because a table home sensor malfunction can cause the device to stop functioning, potentially delaying patient test results.
Product
AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immuno
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0603-2019·2018-12-19
Philips Recalls HeartStart MRx Lithium-Ion Batteries Due to Defective Component
Philips is recalling 1,880 HeartStart MRx lithium-ion batteries because a defective component may prevent the battery from charging or delivering power to the monitor/defibrillator.
Product
HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
Category
Medical Device
Distribution
32 states