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

20976–21000 of 40124

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
ModerateFDA (Devices)·Z-1121-2019·2019-04-17
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 CM42500E-07
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-1090-2019·2019-04-17
Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure
Integra Limited is recalling 232 units of bioBLOCK Resorbable Subtalar Implants because temperature indicators suggest exposure to temperatures greater than 110°F.
Product
Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1119-2019·2019-04-17
Arrow Two-Lumen Central Venous Catheter Set Recalled for Labeling Error
Arrow International Inc is recalling 45 units of Two-Lumen Central Venous Catheterization Sets due to incorrect priming volume labeling on the lidstock.
Product
Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1124-2019·2019-04-17
Roche COBAS INTEGRA 400 plus Recall for Carry-over Issues
Roche Diagnostics is recalling 656 COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.
Product
COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albumin Gen.2 Catalog Number 04469658190 c)Creatinine plus ver.2 Catalog Number 03263991190 d) riglycerides Catalog Number…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1131-2019·2019-04-17
ACUVUE OASYS for Astigmatism Contact Lenses Recalled for Packaging Seal Defects
Johnson & Johnson Vision Care is recalling one lot of ACUVUE OASYS for Astigmatism contact lenses due to potential incomplete packaging seals.
Product
ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1125-2019·2019-04-17
Roche cobas c 111 and COBAS INTEGRA 400 plus analyzers recalled for carry-over
Roche Diagnostics is recalling 137 cobas c 111 and COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.
Product
cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number: 04657594190 - Product Usage: Tina-quant Apolipoprotein A-1 ver.2 A lipoprotein test system is a device intended to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1111-2019·2019-04-17
Beaver Xstar Slit Knife Recalled for Size Mismatch Labeling
Beaver Visitec is recalling 196 boxes of Xstar Slit Knives because the package label indicates a 2.4 mm size, while the device marking shows 2.75 mm.
Product
Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1108-2019·2019-04-17
Conformis Recalls Two iTotal CR Total Knee Replacement Systems
Conformis, Inc. is recalling two iTotal CR Total Knee Replacement Systems prepared with incorrect patient ID labels and potentially incorrect components.
Product
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1130-2019·2019-04-17
Philips Recalls Two Azurion FlexArm Units Due to Cable Damage
Philips is recalling two Azurion FlexArm units because a manufacturing error caused damage to the 24V power cable of the detector.
Product
Azurion FlexArm, 722079
Category
Medical Device
Distribution
1 state

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20976–21000 of 40124