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 27471

SevereFDA (Devices)·Z-2326-2020·2020-06-17
Canon Medical System Recalls 24 Infinix-8000C Digital Radiography Systems
Canon Medical System is recalling 24 Infinix-8000C digital radiography systems because loose bolts may cause the catheterization table to tilt.
Product
Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2342-2020·2020-06-17
RayStation 6 Service Pack 2 Radiation Therapy Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 6 Service Pack 2 software due to a calculation error that could underestimate radiation dose.
Product
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2279-2020·2020-06-17
Genicon Natura Trocar Recall Due to Potential Tip Detachment
Genicon, Inc. is recalling Natura Model 210-005-052 trocars because the plastic optical tip may detach from the metal shaft.
Product
Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two 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
SevereFDA (Devices)·Z-2273-2020·2020-06-17
Genicon Natura Cannula Recall Due to Detachable Optical Tip
Genicon, Inc. is recalling Natura Model 210-005-051 cannulas because the plastic optical tip may detach from the metal shaft.
Product
Genicon Natura Model 210-005-051; 5mm diameter, 70mm 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
SevereFDA (Devices)·Z-2288-2020·2020-06-17
Arrow FlexTip Plus Epidural Kit Recalled for Filter Leak
Arrow International is recalling FlexTip Plus Epidural Kits because a rotatable collar on the filter may detach, causing a leak.
Product
Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-05400-NRON OU-05500-NRON TU-05500-NRON The Arrow Epidural…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2274-2020·2020-06-17
Genicon Natura Cannula Recall Due to Detachable Optical Tip
Genicon, Inc. is recalling Natura Model 210-005-151 cannulas because the plastic optical tip may detach from the metal shaft.
Product
Genicon Natura Model 210-005-151; 5mm diameter, 100mm 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-2305-2020·2020-06-17
Biomet A.L.P.S. Proximal Humerus Plating System Drill Block Set Screw Recalled
Biomet is recalling A.L.P.S. Proximal Humerus Plating System Drill Block Set Screws because they were distributed without completed design history files or design transfer activities.
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2268-2020·2020-06-17
Genicon GENILook Laparoscopic Scope Recall Due to Detaching Optical Tip
Genicon, Inc. is recalling GENILook Model 200-005-153 laparoscopic scopes because the plastic optical tip may detach from the metal shaft.
Product
Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three 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-2271-2020·2020-06-17
Genicon GENILook Medical Device Recalled Due to Detached Optical Tip Risk
Genicon, Inc. is recalling GENILook Model 200-105-152 devices because the plastic optical tip may detach from the metal shaft.
Product
Genicon GENILook Model 200-105-152, 5mm diameter, 100mm 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-2295-2020·2020-06-17
BioFire FilmArray BCID Panel Recalled for False Positive Proteus Results
BioFire Diagnostics is recalling the FilmArray BCID Panel due to an increased risk of false positive Proteus results when used with specific blood culture media.
Product
FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 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
HighFDA (Devices)·Z-2329-2020·2020-06-17
Intuitive Surgical Recalls IS4000 Sterilization Trays Due to Sterility Breach Risk
Intuitive Surgical is recalling IS4000 stainless steel reprocessing trays because small holes in the sterilization wrap could compromise sterility and increase infection risk.
Product
STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2266-2020·2020-06-17
Genicon GENILook Cannula Recalled for Potential Tip Detachment
Genicon, Inc. is recalling GENILook cannulas because the plastic optical tip may detach from the metal shaft. The recall affects 378 boxes distributed in the US and abroad.
Product
Genicon GENILook Model 200-005-151, 5mm diameter, 100mm 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-2347-2020·2020-06-17
RayStation 8B Service Pack 1 Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 8B Service Pack 1 due to a software error that could underestimate radiation dose.
Product
RayStation 8B Service Pack 1, UDI # 07350002010204 - 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-2289-2020·2020-06-17
Elekta Unity Radiation Therapy System Recalled for Legionella Risk
Elekta, Inc. is recalling 32 Unity image-guided radiation therapy systems due to a potential risk of Legionella presence in the machine room heat exchanger condensation collection tray.
Product
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2336-2020·2020-06-17
Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error
Smith & Nephew is recalling 58 R3 Acetabular Shells because a manufacturing error resulted in out-of-specification devices.
Product
smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2335-2020·2020-06-17
Smith & Nephew Recalls R3 Multi Hole Hemispherical Shells Due to Manufacturing Error
Smith & Nephew is recalling 1,766 R3 Multi Hole Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.
Product
smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.
Category
Medical Device
Distribution
0 states
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

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13501–13525 of 27471