Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

10426–10450 of 27441

HighFDA (Devices)·Z-0557-2022·2022-02-09
Chameleon PTA Balloon Catheter difficult protector sleeve removal risk
The Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm has a protector sleeve that may be difficult to remove, potentially damaging the balloon and causing patient harm. Covidien is recalling 1,994 devices.
Product
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0532-2022·2022-02-09
Vagus Nerve Stimulation Therapy Leads Recalled for Tubing Wall Defect
LivaNova's PerenniaDURA vagus nerve stimulation leads may have insufficient silicone tubing thickness due to a manufacturing issue. This could result in unintended stimulation delivery or loss of therapy if the tubing is breached.
Product
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0554-2022·2022-02-09
HARDY DIAGNOSTICS CatScreen diagnostic kit recalled due to improper storage
HARDY DIAGNOSTICS CatScreen test kits (Model HADZ110) are recalled because units were stored in temperature-controlled settings instead of refrigeration. Improper storage may compromise product effectiveness.
Product
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0494-2022·2022-02-02
Trilogy Evo Ventilator Repair Kit Recalled for Degrading Foam Material
Philips Respironics recalled 205 Trilogy Evo ventilator repair kits containing non-conforming foam material that may degrade into particles potentially inhaled or ingested by users. The affected kits were distributed in the US and internationally.
Product
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric…
Category
Medical Device
Distribution
17 states
SevereFDA (Devices)·Z-0493-2022·2022-02-02
Trilogy Evo Ventilator Recalled for Foam Degradation Risk
Philips Respironics recalls 473 Trilogy Evo ventilators due to non-conforming foam that may degrade and release particles. Affected patients risk inhaling or ingesting foam particles and chemicals during device use.
Product
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through…
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-0528-2022·2022-02-02
MAGEC 1 System Recalled for Post-Implantation Component Fractures
The MAGEC 1 System implantable medical device is being recalled due to documented post-implantation fractures of an internal metallic component. The recall affects approximately 3,056 units manufactured before March 26, 2015 and distributed worldwide.
Product
MAGEC 1 System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0527-2022·2022-02-02
Velano PIVO Blood Collection Device 20G units recalled for incomplete package sealing
Velano Vascular is recalling 123,700 PIVO Blood Collection Device 20G units due to incomplete package sealing that could compromise sterile barriers and allow microbial contamination.
Product
PIVO Blood Collection Device 20G, REF: 202-0005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0517-2022·2022-02-02
Diagnostic Imaging Angiography System Software Defects Recalled by Siemens
Siemens is recalling 23 Artis icono angiography systems due to four software defects that could disable imaging, corrupt images, and cause unexpected shutdowns during patient procedures.
Product
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0515-2022·2022-02-02
Siemens Diagnostic Angiography System Recalled for Multiple Software Defects
Siemens is recalling its Artis pheno diagnostic angiography system (12 units) due to four software defects that may prevent imaging, corrupt images, or cause unintended shutdowns during clinical use.
Product
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0516-2022·2022-02-02
Artis icono diagnostic imaging system software defects recalled nationwide
Siemens is recalling 72 units of Artis icono biplane diagnostic imaging systems nationwide due to four software issues that could disable x-ray capability, corrupt diagnostic images, or cause unexpected shutdowns during procedures.
Product
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0526-2022·2022-02-02
Footrest accessory recalled for missing friction rubber block
FDA recalls Intelli-C footrest accessories due to missing friction rubber blocks in the clamping mechanism. The defect may cause the footrest to slip during use.
Product
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-0525-2022·2022-02-02
API ID 32 C Diagnostic Strips Recalled Due to Thermoforming Defect
Biomerieux is recalling API ID 32 C Strips due to a thermoforming defect that risks misidentification of yeasts or delayed diagnostic results. The recall affects 462 kits in Arizona, Iowa, Kentucky, and New York.
Product
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0524-2022·2022-02-02
GE Vscan Extend ultrasound device recalled for power-on failure due to battery depletion
GE Healthcare is recalling the Vscan Extend ultrasound device because it will not power on when the battery is depleted. This occurs when the device is not turned off before battery removal or is connected to a computer without AC power.
Product
GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
Category
Medical Device
Distribution
50 states
CriticalFDA (Devices)·Z-0450-2022·2022-01-26
Medtronic HawkOne Atherectomy System Recalled for Tip Detachment and Embolization Risk
Medtronic is recalling the HawkOne Directional Atherectomy System globally due to reports of tip damage that can detach and cause embolization. The device is used to remove arterial plaque in peripheral blood vessels.
Product
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0451-2022·2022-01-26
Medtronic HawkOne Directional Atherectomy Device Recalled for Tip Damage
Medtronic is recalling 28,094 units of its HawkOne directional atherectomy system due to reports of catheter tip damage and detachment that can cause blood clots in blood vessels.
Product
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0514-2022·2022-01-26
SonarMed AirWave Monitor Kit recall due to alarm and sensor detection failures
Covidien is recalling 66 SonarMed AirWave Monitor Kits because the alarm may fail to sound and sensors may be incorrectly detected as disconnected, potentially causing the monitor to stop monitoring patients without alerting staff.
Product
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0501-2022·2022-01-26
Draeger Fabius MRI Anesthesia Machines recalled due to misrouted oxygen hoses
Draeger Medical recalls 26 Fabius MRI Anesthesia Machines due to incorrectly routed internal oxygen hoses. The misrouting can cause oxygen flow to deviate from set levels, risking inadequate patient oxygenation.
Product
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0513-2022·2022-01-26
Dental implant kits recalled for mislabeled implant dimensions
Straumann USA LLC is recalling certain Neodent Easypack dental implant kits due to mislabeling where packaging does not match the implant dimensions inside. Affected units contain 3.5x8mm implants instead of the labeled 3.5x13mm size.
Product
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0504-2022·2022-01-26
Gentueri Viral Transport Medium Recalled Due to Turbidity and Discoloration
Gentueri Inc is recalling 4,150 units of Gentueri Viral Transport Medium (VTM) nationwide due to visual turbidity and discoloration that may compromise diagnostic samples in transit.
Product
Gentueri Viral Transport Medium (VTM), Sterile, IVD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0503-2022·2022-01-26
VITROS High Sample Diluent A Reagent Produces Lower Than Expected Results
Ortho-Clinical Diagnostics is recalling VITROS High Sample Diluent A Reagent Pack Lot 2190 because it produces lower than expected TSH test results. The recall affects 1,416 units distributed worldwide.
Product
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0500-2022·2022-01-26
ImagePilot diagnostic imaging software versions 1.92 and 1.93 measurement error recall
Konica Minolta's ImagePilot versions 1.92 and 1.93 software may provide incorrect measurement calculations if improper power sequences are used with AeroDR or Momentum Panel systems.
Product
ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0510-2022·2022-01-26
Voyager Rollator Walkers Recalled for Wheel Separation and Fall Risk
Compass Health Brands is recalling 3,734 Voyager Rollator walkers due to cracking wheel spokes that may cause wheels to separate from the axle, potentially resulting in patient falls and injuries.
Product
Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0511-2022·2022-01-26
Microbiological Reference Products Recalled for Bacterial Contamination
Microbiologics Inc is recalling KWIK-STIK and LYFO DISK microbiological reference products contaminated with Staphylococcus epidermidis. Fifty-nine kits were distributed to multiple U.S. states and countries.
Product
KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-0512-2022·2022-01-26
Dental Implant Mislabeling: Neodent Easypack Helix GM Acqua Dimension Error
Straumann USA LLC recalls Neodent Easypack Helix GM Acqua dental implants due to mislabeling. Implants have incorrect dimensions compared to carton labels, which could affect surgical planning and placement.
Product
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0497-2022·2022-01-26
Senior Living Nurse Call Systems Failing to Alarm Due to Memory Issue
Stanley Security Solutions is recalling 11 Senior Living Arial Emergency and Nurse Call Systems because they fail to alarm due to increased memory consumption, potentially preventing nursing staff from responding to resident emergencies.
Product
Senior Living Arial Emergency and Nurse Call Systems
Category
Medical Device
Distribution
Distributed nationwide

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10426–10450 of 27441