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

16101–16125 of 27500

HighFDA (Devices)·Z-1139-2019·2019-04-24
Pintler Medical Recalls 24 Warming Pads Due to Malfunction
Pintler Medical LLC is recalling 24 warming pads used in operating rooms because they malfunction. The affected units were distributed to facilities in Wisconsin.
Product
A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol
Category
Medical Device
Distribution
1 state
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-1178-2019·2019-04-24
Olympus Diego Elite Console Recall for Unintended RF Energy Activation
Gyrus ACMI is recalling Olympus Diego Elite Consoles because they may inadvertently activate the RF energy feature when used with specific blades.
Product
Olympus Diego Elite Console MDCONS 100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1196-2019·2019-04-24
Abbott Alinity i Processing Module Recalled for Safety Interlock Defect
Abbott is recalling Alinity i Processing Modules because a safety interlock may fail to deploy when a bulk solution bottle is removed.
Product
Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1092-2019·2019-04-24
ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Burr Risk
ICU Medical is recalling certain lots of ChemoClave Vented Vial Spikes because plastic burrs from the protective cap may contaminate the device.
Product
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1123-2019·2019-04-17
Encore Medical Recalls Exprt Precision System Hip Implant Components
Encore Medical is recalling 22 units of Exprt Precision System hip implant components due to loose or improperly seated bolts that may cause pain or require revision surgery.
Product
Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085
Category
Medical Device
Distribution
26 states
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1128-2019·2019-04-17
DePuy Orthopaedics Recalls CORAIL AMT COXA VARA Neck Segments
DePuy Orthopaedics is recalling CORAIL AMT COXA VARA Neck Segments because debris or material may be found behind the O-rings.
Product
CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1104-2019·2019-04-17
Abbott ARCHITECT c16000 Processing Module Recalled for Potential Incorrect Results
Abbott Laboratories is recalling 1,666 ARCHITECT c16000 Processing Modules worldwide because unresolved error codes may cause the instrument to generate incorrect diagnostic results.
Product
Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1099-2019·2019-04-17
LivaNova Recalls Six Sorin Heater-Cooler Systems Due to Bacteria
LivaNova USA Inc. is recalling six Sorin Heater-Cooler System 3T units because post-cleaning water samples tested positive for nontuberculous mycobacteria.
Product
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1122-2019·2019-04-17
BD Blood Collection Assembly Recalled for Luer Breakage Risk
Becton Dickinson is recalling 6.5 million blood collection assemblies because the luer could break, causing leaks or blocking dialysis ports.
Product
BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1129-2019·2019-04-17
DePuy CORAIL AMT High Offset Neck Segment Recall for Potential Debris
DePuy Orthopaedics is recalling CORAIL AMT High Offset Neck Segments because debris or material may be found behind the O-rings.
Product
CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1112-2019·2019-04-17
Siemens syngo.CT Cardiac Function Software Recalled for TAVI Measurement Risk
Siemens is recalling syngo.CT Cardiac Function software due to a potential risk of wrong measurement in the annulus plane during TAVI planning.
Product
syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1102-2019·2019-04-17
Abbott ARCHITECT c4000 Processing Module Recalled for Potential Incorrect Results
Abbott Laboratories is recalling 3,675 ARCHITECT c4000 Processing Modules because specific unresolved error codes may cause the instrument to generate incorrect diagnostic results.
Product
Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1103-2019·2019-04-17
Abbott ARCHITECT c8000 Processing Module Recall for Potential Incorrect Results
Abbott is recalling 3,794 ARCHITECT c8000 Processing Modules because unresolved error codes may cause the instrument to generate incorrect diagnostic results.
Product
Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1115-2019·2019-04-17
Vygon DUALSTOP White Caps Recalled for Defect Causing Leaks
Vygon U.S.A. is recalling Vyon DUALSTOP White Caps used for intravascular lines because a defect causes leaks in the affected product.
Product
Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1127-2019·2019-04-17
DePuy CORAIL Neck Trials Recalled for Potential Debris Behind O-rings
DePuy Orthopaedics is recalling CORAIL AMT Standard Offset Neck Segments because debris or material may be found behind the O-rings. These surgical instruments are used in hip arthroplasty.
Product
CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1113-2019·2019-04-17
Siemens Medical Solutions Recalls syngo.via Cardiac Planning Software
Siemens Medical Solutions is recalling syngo.via syngo.CT Cardiac Planning software due to a potential risk of incorrect measurements during TAVI planning procedures.
Product
syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1114-2019·2019-04-17
Vygon DUALSTOP Red Caps Recalled for Defects Causing Leaks
Vygon U.S.A. is recalling 339,800 DUALSTOP Red Caps used for intravascular lines because a defect causes leaks.
Product
Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1120-2019·2019-04-17
Becton Dickinson Recalls Gravity IV Sets Due to Kinked Tubing
Becton Dickinson is recalling specific lots of Gravity IV Sets with 3-port Closed Stopcock Manifolds due to a confirmed complaint trend for kinked tubing.
Product
Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1109-2019·2019-04-17
Elekta Unity MRI Radiation Therapy System Recalled for Image Protocol Issues
Elekta Limited is recalling 12 Unity MRI-guided radiation therapy systems because acquired images may not represent average anatomy during respiratory motion, potentially affecting treatment accuracy.
Product
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0977-2019·2019-04-10
O-Two Medical e600 Ventilator Recalled for Fire Risk
O-Two Medical is recalling 119 e600 Automatic Transport Ventilators because a manufacturing defect may cause the unit to catch fire.
Product
e600 Automatic Transport Ventilator, Model Number 01EVE600
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-0978-2019·2019-04-10
O-Two Medical e700 Ventilator Recalled for Fire Risk
O-Two Medical Technologies is recalling 632 e700 Automatic Transport Ventilators because a manufacturing defect could cause the unit to catch fire.
Product
e700 Automatic Transport Ventilator, Model Number 01EVE700
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-0976-2019·2019-04-10
O-Two Medical e500 Ventilator Recalled for Fire Hazard
O-Two Medical is recalling 136 e500 Automatic Transport Ventilators because a manufacturing defect may cause the unit to catch fire.
Product
e500 Automatic Transport Ventilator, Model Number 01EVE500
Category
Medical Device
Distribution
8 states

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16101–16125 of 27500