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

13501–13525 of 27500

HighFDA (Devices)·Z-2331-2020·2020-06-17
Smith & Nephew R3 Acetabular Shells Recalled for Manufacturing Error
Smith & Nephew is recalling R3 No Hole Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.
Product
smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2333-2020·2020-06-17
Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error
Smith & Nephew is recalling R3 Acetabular Shells because a manufacturing error resulted in out-of-specification devices.
Product
smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2276-2020·2020-06-17
Genicon Natura Cannula Recalled Due to Potential Tip Detachment
Genicon, Inc. is recalling Natura Model 210-005-251 cannulas because the plastic optical tip may detach from the metal shaft.
Product
Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2346-2020·2020-06-17
RayStation 8B Software Recall for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation 8B software due to errors in dose calculation algorithms that could underestimate radiation dose.
Product
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2291-2020·2020-06-17
Biocare Medical Recalls 4plus Streptavidin HRP Label Due to Staining Failure
Biocare Medical is recalling 4plus Streptavidin HRP Label kits because they may fail to stain, potentially causing invalid test results and delayed diagnoses.
Product
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2341-2020·2020-06-17
RayStation 6 Radiation Therapy Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 6 software due to a calculation error that may underestimate radiation dose.
Product
RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2267-2020·2020-06-17
Genicon GENILook Medical Device Recalled Due to Detachment Risk
Genicon, Inc. is recalling GENILook Model 200-005-152 medical devices because the plastic optical tip may detach from the metal shaft.
Product
Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2343-2020·2020-06-17
RayStation 6 Service Pack 3 Radiation Therapy Software Recall
RaySearch Laboratories is recalling RayStation 6 Service Pack 3 software due to a calculation error that could underestimate radiation dose.
Product
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2353-2020·2020-06-17
RayStation 7 Software Recalled for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation 7 software due to errors in dose calculation algorithms that may underestimate radiation dose.
Product
RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2278-2020·2020-06-17
Genicon GENILook Medical Device Recalled for Potential Tip Detachment
Genicon, Inc. is recalling GENILook Model 200-105-252 devices because the plastic optical tip may detach from the metal shaft.
Product
Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2334-2020·2020-06-17
Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error
Smith & Nephew is recalling 4,172 R3 Acetabular Shells distributed worldwide because a manufacturing error resulted in out-of-specification devices.
Product
smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2283-2020·2020-06-17
Siemens Atellica CH Enzymatic Creatinine Recalled for Acetaminophen Interference
Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.
Product
Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2338-2020·2020-06-17
Philips Recalls IntelliSpace PACS 4.4 Due to Potential Image Corruption
Philips Healthcare Informatics is recalling 26 units of IntelliSpace PACS 4.4 because images may potentially become corrupt while using the system.
Product
IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2270-2020·2020-06-17
Genicon GENILook Cannula Recalled Due to Potential Tip Detachment
Genicon, Inc. is recalling GENILook Model 200-105-151 cannulas because the plastic optical tip may detach from the metal shaft.
Product
Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2282-2020·2020-06-17
Siemens ADVIA Chemistry Enzymatic Creatinine Recalled for Acetaminophen Interference
Siemens is recalling ADVIA Chemistry Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.
Product
ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2351-2020·2020-06-17
RayStation 9B Software Recall for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation 9B Service Pack 1 due to a software error in dose calculation algorithms that could result in local underestimation of expected radiation dose.
Product
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2299-2020·2020-06-17
Inari Medical Recalls Triever20 Aspiration Guide Catheter for Valve Failure
Inari Medical is recalling 318 Triever20 Aspiration Guide Catheters because the hemostasis valve may fail to seal, causing loss of vacuum during thrombus aspiration.
Product
Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-2345-2020·2020-06-17
RayStation 8A Software Recall for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 8A Service Pack 1 software due to a dose calculation error that could underestimate radiation therapy doses.
Product
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2354-2020·2020-06-17
Acuity A Link Z Spinal Fusion Device Recalled for Manufacturing Defect
Acuity Surgical Devices is recalling 178 A Link Z intervertebral body fusion devices because a manufacturing issue prevented bone screws from seating properly.
Product
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32x21x15 12 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2352-2020·2020-06-17
RayStation 6 Service Pack 1 Radiation Therapy Software Recall
RaySearch Laboratories is recalling RayStation 6 Service Pack 1 software due to a calculation error that may underestimate radiation dose.
Product
RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2265-2020·2020-06-17
ROi CPS Recalls Custom Procedure Kits Containing Recalled BD Syringes
ROi CPS LLC is recalling 40 custom procedure kits because they contain PosiFlush Syringes from a lot previously recalled by BD.
Product
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2350-2020·2020-06-17
RayStation 9B Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 9B software due to a dose calculation error that could underestimate radiation therapy doses.
Product
RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2262-2020·2020-06-17
Ventana HE 600 Recalled for Electrical Short Risk
Ventana Medical Systems is recalling 461 HE 600 instruments due to a cleaning solution leak that can cause electrical shorts and burned components.
Product
Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2332-2020·2020-06-17
Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error
Smith & Nephew is recalling 1,450 R3 Zero Hole HA Coated Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.
Product
smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2296-2020·2020-06-17
BioFire FilmArray BCID Panel Recalled for False Positive Proteus Results
BioFire Diagnostics is recalling FilmArray BCID Panels due to a risk of false positive Proteus results when used with specific blood culture media, which may lead to improper antibiotic treatment.
Product
FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT¿ FA Plus 410852/BACT/ALERT¿ FN Plus 410853/BACT/ALERT¿ PF Plus 259790/BACT/ALERT¿ SN…
Category
Medical Device
Distribution
Distributed nationwide

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13501–13525 of 27500