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 deaths or serious injuries are reported, 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

2151–2175 of 5111

SevereFDA (Devices)·Z-0734-2021·2021-01-20
Boston Scientific Recalls Lotus Edge Valve Systems Due to Deployment Failure Risk
Boston Scientific is recalling 207 Lotus Edge Valve Systems because a visual inspection error could prevent the delivery system from releasing during deployment.
Product
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
Category
Medical Device
Distribution
38 states
SevereFDA (Devices)·Z-0852-2021·2021-01-20
Philips Emission Computed Tomography System Software Defect Recall
Philips is recalling 2,714 Emission Computed Tomography Systems due to a software defect that may cause image misdiagnosis and incorrect patient treatment.
Product
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0813-2021·2021-01-20
Fresenius Recalls NaturaLyte Liquid Acid Concentrate Bottles
Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.
Product
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0838-2021·2021-01-20
Fresenius Naturalyte Liquid Acid Concentrate Recalled for Conductivity Deviation
Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and calcium concentration below manufacturing specifications.
Product
Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0828-2021·2021-01-20
Fresenius Citrasate Liquid Acid Concentrate Recall Due to Low Sodium Levels
Fresenius Medical Care is recalling 198 drums of Citrasate Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.
Product
Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0778-2021·2021-01-13
Boston Scientific Recalls Hot AXIOS Stent Delivery Systems Due to Detachment Risk
Boston Scientific is recalling 78 units of Hot AXIOS Stent and Electrocautery delivery systems because a fitting may detach, risking peritonitis.
Product
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0775-2021·2021-01-13
Boston Scientific Recalls AXIOS Stent Delivery Systems Due to Fitting Detachment Risk
Boston Scientific is recalling 38 units of AXIOS Stent and Electrocautery delivery systems because a fitting may detach, risking peritonitis.
Product
AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0773-2021·2021-01-13
Boston Scientific Recalls AXIOS Stent Delivery System Due to Fitting Detachment
Boston Scientific is recalling 13 units of the AXIOS Stent and Electrocautery - Enhanced Delivery System because a fitting may detach, risking peritonitis.
Product
AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0776-2021·2021-01-13
Boston Scientific Recalls Hot AXIOS Stent Delivery System Due to Fitting Detachment
Boston Scientific is recalling 8 units of the Hot AXIOS Stent and Electrocautery - Enhanced Delivery System because a fitting may detach, risking peritonitis.
Product
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0800-2021·2021-01-13
Ortho-Clinical enGen Laboratory Automation System Software Recall
Ortho-Clinical Diagnostics is recalling 40 enGen Laboratory Automation Systems due to a software anomaly that may cause sample mislabeling, potentially leading to incorrect patient results and inappropriate medical intervention.
Product
enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-se
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0785-2021·2021-01-13
Accuray Recalls TomoTherapy Systems Due to Potential Radiation Dose Rotation Error
Accuray is recalling eight TomoTherapy Treatment Delivery Systems because an MLC tickle error may cause the delivered radiation dose to rotate from the planned dose.
Product
TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of r
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0748-2021·2021-01-06
FDA Recalls Covidien TA Auto Suture Vascular Loading Units
FDA is recalling specific lots of Covidien TA Auto Suture Vascular Loading Units due to a damaged internal component that may prevent adequate hemostasis.
Product
Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0761-2021·2021-01-06
BD Phoenix PMIC-107 Recalled for False SXT Resistance Results
Becton Dickinson is recalling BD Phoenix PMIC-107 IVDs because false resistant results for S. aureus could lead to reduced treatment effectiveness.
Product
BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448417
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0766-2021·2021-01-06
BD Phoenix PMIC-110 Recalled for False SXT Resistance Results
Becton Dickinson & Co. is recalling BD Phoenix PMIC-110 IVDs due to false resistant SXT results with S. aureus, which could impact antibiotic treatment.
Product
BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 449036:
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0747-2021·2021-01-06
FDA Recalls Covidien TA Auto Suture Vascular Staplers Due to Damaged Components
The FDA is recalling specific lots of Covidien TA Auto Suture Vascular Staplers because a damaged internal component may prevent adequate hemostasis or cause tissue damage.
Product
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0599-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducer Sheaths Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducer sheaths because the proximal bond site may separate, potentially causing life-threatening adverse events such as embolization or hemorrhage.
Product
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0594-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0707-2021·2020-12-30
ICU Medical Recalls ChemoLock Administration Sets Due to Molding Defect
ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.
Product
31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3020; ChemoLock Port w/Spiros, Red Cap, REF: CL-35; 3
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0653-2021·2020-12-30
CryoLife Recalls CryoPatch SG Pulmonary Human Cardiac Patch Units
CryoLife, Inc. is recalling two units of CryoPatch SG Pulmonary Human Cardiac Patch due to post-processing microbial culture test failures.
Product
CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0603-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0600-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0607-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0608-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling 228 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0596-2021·2020-12-30
Flexor Check-Flo Introducer sheath separation recall due to potential life-threatening complications
The FDA is recalling the Flexor Check-Flo Introducer because its sheath may separate at the proximal bond site, potentially causing serious complications such as embolization, vessel injury, or hemorrhage.
Product
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0605-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide

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2151–2175 of 5111