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.

1676–1700 of 1800

HighFDA (Devices)·Z-0518-2014·2013-12-25
Kimberly-Clark Epidural Pain Management Trays Recalled for Syringe Defect
Kimberly-Clark is recalling Single Shot Epidural Pain Management Trays because the included BD LOR Syringes may stall or stick.
Product
Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0533-2014·2013-12-25
Integra Epidural Anesthesia Kits Recalled Due to Syringe Plunger Defect
Integra LifeSciences is recalling specific lots of epidural anesthesia kits because the included BD LOR syringe plunger may stall or stick.
Product
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are u
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0457-2014·2013-12-18
Hospira Recalls Receptal Canisters Due to Suction Failure
Hospira is recalling 1L Receptal Canisters because the canister and liner may not seat properly, preventing the creation of necessary suction.
Product
Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA. Used to isolate suction waste during surgeries, or to clear patient airways, throat or wounds to allow treatment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0352-2014·2013-11-27
Spacelabs recalls anesthesia workstation absorbers due to potential switch failure
Spacelabs Healthcare is recalling CAS I/II Absorbers for Blease anesthesia workstations because the Bag-to-Vent switch may fail due to loose hardware.
Product
CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anest
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0364-2014·2013-11-27
Biomet Recalls Juggerknotless Drill Bits Due to Insertion Difficulty
Biomet, Inc. is recalling 25 units of Juggerknotless Drill Bits because the design may make it difficult to insert the suture anchor into the bone.
Product
Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0288-2014·2013-11-20
Hospira Recalls Plum A+3 Infusion Systems Due to Broken Sensor Pin Risk
Hospira is recalling 7,692 Plum A+3 Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0289-2014·2013-11-20
Hospira Recalls Plum A+3 Infusion Systems Due to Broken Sensor Pin Risk
Hospira is recalling 21,551 Plum A+3 Infusion Systems because a distal pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0197-2014·2013-11-20
Baxter Recalls SIGMA SPECTRUM Infusion Pumps Due to Alarm Issues
Baxter Healthcare is recalling SIGMA SPECTRUM Infusion Pumps because they may trigger false upstream occlusion or air-in-line alarms during use.
Product
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0204-2014·2013-11-20
Infusion pumps are recalled for distal pressure sensor drift
Hospira recalled 10,669 Plum A+ infusion pumps after reports of distal pressure sensor calibration drift. The issue may cause false occlusion alarms or distal occlusions.
Product
Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0150-2014·2013-11-13
Ethicon Adjustable Gastric Band Recalled for Force to Lock Failure
Ethicon Endo-Surgery Inc is recalling 2,475 Adjustable Gastric Bands because aging studies showed they failed to meet Force to Lock test requirements.
Product
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0083-2014·2013-11-06
Medtronic Recalls Thoracic Stent Grafts Due to Flushing Difficulty
Medtronic Vascular is recalling Valiant and Talent Thoracic Stent Grafts with Captivia Delivery Systems because the graft cover is difficult to flush during preparation.
Product
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0047-2014·2013-10-30
Abbott Recalls STAR Excimer Laser Systems Due to Power Component Failure
Abbott Medical Optics is recalling STAR Excimer Laser Systems because a power component failure can cause the lamp and illumination system to malfunction.
Product
STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2319-2013·2013-10-09
DeVilbiss Disposable Suction Container Filter Recall Due to Fluid Exposure
DeVilbiss Healthcare LLC is recalling specific Disposable Suction Container/Filter units because fluid exposure can occlude the bacterial filter, rendering it unusable.
Product
DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Contain
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2269-2013·2013-10-02
Smiths Medical Recalls Port-A-Cath Venous Access Systems Due to Sizing Issue
Smiths Medical is voluntarily recalling Port-A-Cath and Port-A-Cath II implantable venous access systems and introducer sets because the introducer sheath opening may be too small for the catheter.
Product
Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. Sterile EO, Rx Only. PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venou
Category
Medical Device
Distribution
25 states
ModerateFDA (Devices)·Z-2268-2013·2013-10-02
Smiths Medical Recalls PORT-A-CATH Introducer Sets Due to Sizing Issues
Smiths Medical is voluntarily recalling PORT-A-CATH Introducer Sets because the sheath opening may be too small for the catheter width.
Product
Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-2256-2013·2013-09-25
GE Healthcare Recalls CARESCAPE Monitor B650 Due to Potential Issues
GE Healthcare is recalling CARESCAPE Monitor B650 units due to potential issues. No injuries or illnesses have been reported.
Product
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2161-2013·2013-09-18
GE Healthcare Recalls Tec 6 Anesthesia Vaporizers Due to Leak Detection Issue
GE Healthcare is recalling Tec 6 and Tec 6 Plus anesthesia vaporizers because the pre-operative leak test may fail to detect leaks caused by seal wear.
Product
Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped wit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2163-2013·2013-09-18
B. Braun Outlook ES Infusion Pumps Recalled for Key Panel Failure
B. Braun Medical Inc. is recalling Outlook ES Safety Infusion Systems because the HOLD button may fail to function due to intermittent circuitry contact.
Product
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid co
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2193-2013·2013-09-18
CareFusion Recalls Thoracentesis Trays Due to Catheter Occlusion Risk
CareFusion is recalling Thoracentesis and Safe-T Thoracentesis Trays because the included catheters may occlude, potentially delaying medical procedures and causing patient complications.
Product
*** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road; M
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2133-2013·2013-09-11
DePuy Spine Recalls Confidence Spinal Cement System Due to Pump Leak
DePuy Spine is recalling the Confidence Spinal Cement System 11CC Plus Kit because water leaks in the hydraulic pump cause pressure loss, preventing cement injection.
Product
CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplast
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-2086-2013·2013-09-04
Alphatec Recalls Illico Ti Cannulated Polyaxial Screws Due to Manufacturing Defect
Alphatec Spine is recalling specific lots of Illico Ti Cannulated Polyaxial Screws because an off-center hole may prevent guide wires from passing through during surgery.
Product
Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2113-2013·2013-09-04
DeRoyal Recalls Insufflation Tubing Sets Due to Materials Incompatibility
DeRoyal Industries is recalling specific lots of insufflation tubing sets because materials incompatibility could cause occlusion, potentially preventing gas flow during laparoscopic surgery.
Product
DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only 5) REF 28-0208 Insu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1979-2013·2013-08-28
Boston Scientific Recalls ENERGEN DR ICD Due to Test Artifacts
Boston Scientific is recalling one ENERGEN DR ICD (Model E143) because test artifacts related to shock charge time require further investigation.
Product
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1871-2013·2013-08-14
SpineFrontier Recalls Chameleon FacetFuse Drill Guides Due to Mechanical Interference
SpineFrontier, Inc. is recalling 13 Chameleon FacetFuse Drill Guides because denting and bending prevented proper surgical use.
Product
Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1847-2013·2013-08-07
Hospira Symbiq Infusion System Recalled for Secondary Audio Signal Failure
Hospira Inc. is recalling 2,791 Symbiq Infusion Systems because the secondary audio signal fails to activate. The devices were distributed across 22 US states.
Product
The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
Category
Medical Device
Distribution
22 states