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.

1376–1400 of 1800

HighFDA (Devices)·Z-2174-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2175-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2185-2016·2016-07-20
Stryker Target Nano Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035453040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2187-2016·2016-07-20
Stryker Target Nano Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.
Product
Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M0035453080 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2177-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may cause the coils to stretch.
Product
Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443560 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2071-2016·2016-07-06
Pentax Recalls 9,669 Gastroscope Units Due to Lodged Accessories
Pentax Medical is recalling 9,669 gastroscope units because operational or cleaning accessories can become lodged in the instrument channel.
Product
Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth w
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2077-2016·2016-07-06
Pentax Ultrasound Gastroscope Recall Due to Lodged Accessories
Pentax Medical Company is recalling ultrasound gastroscopes because operational and therapeutic accessories can become lodged in the instrument channel.
Product
Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying a
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2074-2016·2016-07-06
Pentax Naso-Pharyngo-Laryngoscope Recall Due to Lodged Accessories
Pentax Medical Company is recalling 215 Naso-Pharyngo-Laryngoscopes because operational and therapeutic accessories can become lodged in the instrument channel.
Product
Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or th
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2072-2016·2016-07-06
Pentax Intubation Scope Recall Due to Lodged Accessories in Instrument Channel
Pentax Medical Company is recalling 1,220 intubation scopes because operational and therapeutic accessories can become lodged in the instrument channel.
Product
Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. The
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2067-2016·2016-07-06
Pentax Choledochoscope Recall Due to Potential Instrument Channel Lodging
Pentax Medical is recalling 50 units of FCP-8P and FCP-9P choledochoscopes because accessories and therapeutic devices may become lodged in the instrument channel.
Product
Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the w
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1964-2016·2016-06-22
Staar Surgical Recalls STAAR AQ Cartridge-FP Intraocular Lens Delivery Systems
Staar Surgical Co. is recalling 2,612 units of the STAAR AQ Cartridge-FP because the device may crack during loading or delivery of intraocular lenses.
Product
STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0956-2016·2016-06-15
Novo Nordisk Recalls Norditropin Pens Due to Delivery System Defect
Novo Nordisk is recalling 723 Norditropin FlexPro pens due to a potential assembly fault that may cause the pen to block during the air shot step.
Product
NORDITROPIN — NORDITROPIN (SOMATROPIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1833-2016·2016-06-15
Hospira Recalls 2,567 Plum A+ Infusion Pumps Due to Calibration Error
Hospira is recalling 2,567 Plum A+ infusion pumps because a calibration error caused false occlusion alarms. The devices were distributed in the U.S. and 13 foreign countries.
Product
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1707-2016·2016-06-01
GE Healthcare Discovery IGS 740 Systems Recalled for Image Loss
GE Medical Systems is recalling 25 Discovery IGS 740 systems due to potential non-recoverable loss of image acquisition during procedures.
Product
GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1706-2016·2016-06-01
GE Healthcare Discovery IGS 730 Recalled for Potential Image Loss
GE Medical Systems is recalling 54 Discovery IGS 730 systems due to a risk of non-recoverable loss of image acquisition during procedures.
Product
GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1693-2016·2016-05-25
Alcon Recalls 23G and 25G Constellation Totalplus Paks for Potential Leakage
Alcon Research, Ltd. is recalling 225,000 units of 23G and 25G Constellation Totalplus Paks because the products have the potential to leak beyond their design specifications.
Product
23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1621-2016·2016-05-18
Applied Medical Direct Drive Clip Applier Recalled for Inconsistent Application
Applied Medical Resources Corp is recalling Direct Drive Clip Applier CA090 units due to inconsistent clip application that may lead to unoccluded vessels.
Product
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-1617-2016·2016-05-18
C.R. Bard Recalls Arctic Sun Temperature Management Systems
C.R. Bard is recalling 2,613 Arctic Sun Temperature Management Systems because electronic components may cause the internal battery to drain prematurely, rendering the device unresponsive.
Product
Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature
Category
Medical Device
Distribution
48 states
HighFDA (Devices)·Z-1606-2016·2016-05-11
CareFusion Alaris PC Unit Model 8015 Recalled for Power-Up Error
CareFusion 303, Inc. is recalling 23,397 Alaris PC units, Model 8015, because a super capacitor failure may cause a system error code at power-up.
Product
Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1544-2016·2016-04-27
Smith & Nephew Recalls TC-Plus Tibial Knee Prosthesis Components
Smith & Nephew is recalling 24 units of TC-Plus tibial knee prosthesis components due to a dimensional deviation that may prevent proper seating during surgery.
Product
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1525-2016·2016-04-27
Coloplast Recalls Pediatric Catheters Due to Missing Eyelets
Coloplast is voluntarily recalling a single lot of Self-Cath Pediatric Catheters because some units have missing eyelets, which can cause catheter malfunction.
Product
Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter is indicated for use by patients with chronic urine ret
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1362-2016·2016-04-20
US Endovascular Recalls Ebony PTA Catheters Due to Kinking Risk
US Endovascular is recalling 843 Ebony PTA catheters because they may kink during use, rendering them unusable.
Product
USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-1396-2016·2016-04-20
Bard TruGuide Biopsy Needle Recall Due to Incorrect Stylet Size
Bard Peripheral Vascular is recalling TruGuide Disposable Coaxial Biopsy Needles because they may contain an incorrectly sized blunt tip stylet that will not pass through the coaxial.
Product
Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-1194-2016·2016-03-30
Algovita External Pulse Generator Recalled for Connection Issues
QiG Group LLC is recalling 31 Algovita External Pulse Generators because they may fail to connect to external devices, preventing reprogramming and recharging.
Product
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1191-2016·2016-03-30
Intuitive Surgical Recalls da Vinci Surgeon Side Console Touchpads
Intuitive Surgical is recalling 542 da Vinci Si and Xi Surgeon Side Console touchpads due to a Class II defect. The recall covers units distributed in the US and 33 other countries.
Product
da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary a
Category
Medical Device
Distribution
0 states