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

14851–14875 of 39988

HighFDA (Devices)·Z-1258-2021·2021-04-07
ThermaCor 1200 Disposable Sets Recalled for Potential Aluminum Leaching
Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets because a toxicological assessment found potential for aluminum ions to leach into warmed fluids.
Product
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1305-2021·2021-04-07
Medtronic Recalls Implantable Cardioverter Defibrillators Due to Shortened Replacement Time
Medtronic is recalling specific Evera and Visia ICD models because a small percentage may experience a shortened Recommended Replacement Time to End of Service interval.
Product
Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1260-2021·2021-04-07
ThermaCor 1200 Disposable Sets Recalled for Potential Aluminum Leaching
Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets due to a toxicological risk assessment indicating potential aluminum ion leaching into warmed fluids.
Product
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1318-2021·2021-04-07
EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
EPIX Therapeutics is recalling 60 units of DiamondTemp Unidirectional Large Curve Ablation Catheters because packaging and instructions list incorrect catheter sizes, posing a risk of blood clots or air emboli.
Product
EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF: CEDT200L, Sterile EO, UDI: 00812499030259
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1320-2021·2021-04-07
EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
EPIX Therapeutics is recalling 18 units of DiamondTemp Bidirectional Large Curve Ablation Catheters because packaging and instructions list incorrect sizes, posing a risk of blood clots or air emboli.
Product
EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1324-2021·2021-04-07
Nuvasive Precice Bone Transport Nail Recalled for Biological Safety Concerns
Nuvasive Specialized Orthopedics is recalling 226 Precice Bone Transport nails due to complaints of pain and bony abnormalities related to biological safety.
Product
Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1328-2021·2021-04-07
Alcon Custom Ophthalmic Surgical Procedure Packs Recalled for Mold
Alcon is recalling 249,853 custom ophthalmic surgical procedure packs because mold was found on gowns included in the packages.
Product
Alcon Custom Ophthalmic Surgical Procedure Packs
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1317-2021·2021-04-07
EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
EPIX Therapeutics is recalling 100 units of DiamondTemp Unidirectional Small Curve Ablation Catheters because packaging and instructions list incorrect catheter sizes, posing a risk of blood clots or air emboli.
Product
EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1342-2021·2021-04-07
Diasorin Recalls LIAISON 1-84 PTH Assay Due to Falsely Elevated Results
Diasorin Inc. is recalling LIAISON 1-84 PTH Assay kits because the system may produce falsely elevated parathyroid hormone results.
Product
LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1325-2021·2021-04-07
Nuvasive Recalls PRECICE Plates Due to Biological Safety Concerns
Nuvasive Specialized Orthopedics Inc is recalling 40 PRECICE Plate units worldwide due to complaints of adverse events potentially related to biological safety.
Product
PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1319-2021·2021-04-07
EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
EPIX Therapeutics is recalling 15 DiamondTemp Bidirectional Small Curve Ablation Catheters because the packaging and instructions for use list incorrect catheter sizes.
Product
EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, SterileEO, UDI: 00812499030358
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1333-2021·2021-04-07
Biocare Medical IntelliPath FLX Automated Staining Instrument Recall
Biocare Medical is recalling 72 IntelliPath FLX instruments due to a software defect that may cause random movement and buffer dispensing errors.
Product
BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1306-2021·2021-04-07
Medtronic Recalls CRT-D Devices Due to Shortened Replacement Time
Medtronic is recalling specific CRT-D implantable cardioverter defibrillators because a small percentage may experience a shortened time before the device reaches end of service.
Product
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1309-2021·2021-04-07
CareFusion Recalls BD Alaris Infusion Pump Keypads Due to Fluid Ingress
CareFusion is recalling BD Alaris Infusion Pump Module Keypads and Door Assembly Kits because fluid ingress can cause unresponsive or stuck keys, potentially delaying medication infusion.
Product
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1311-2021·2021-04-07
Hollister Recalls Vertical Drain Tube Attachment Devices Due to Separation Risk
Hollister Incorporated is recalling Vertical Drain Tube Attachment Devices (VTAD) because the tube holder can separate from the securing barrier, risking tube migration or loss.
Product
Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to stabilize and secure a variety of catheters, surgical drains, and tubes from sizes 5-40 French.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1321-2021·2021-04-07
EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors
EPIX Therapeutics is recalling 19 DiamondTemp Unidirectional Ablation Catheters because packaging and instructions list incorrect sizes, posing a risk of blood clots or air emboli.
Product
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1322-2021·2021-04-07
EPIX Therapeutics DiamondTemp Catheter Recalled for Labeling Errors
EPIX Therapeutics is recalling 13 DiamondTemp Unidirectional Ablation Catheters because packaging and instructions list incorrect sizes, posing a risk of blood clots or air emboli.
Product
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1315-2021·2021-04-07
DePuy Orthopaedics Recalls Mobile Bearing Total Knee Systems Due to Packaging Damage
DePuy Orthopaedics is recalling specific lots of the LCS COMPLETE P.F.C. SIGMA RP Mobile Bearing Total Knee System because of potential damaged packaging.
Product
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1329-2021·2021-04-07
Oscor SafeSheath ULTRALITE 10F Recalled for Potential Open Sterile Seal
Oscor, Inc. is recalling 500 units of the AngioDynamics SafeSheath ULTRALITE 10F due to a potential open seal on the sterile product.
Product
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1327-2021·2021-04-07
Stryker Harmonic ACE +7 Shears Recalled for Lack of Regulatory Clearance
Stryker is recalling 102 units of Harmonic ACE +7 Shears because they were distributed without receiving regulatory clearance.
Product
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1312-2021·2021-04-07
LumiraDx Coronavirus Antigen Test Strips Recalled for False Positives
LumiraDx is recalling 2,186 coronavirus antigen test strips because two lots failed quality control testing and produced false positives.
Product
Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1316-2021·2021-04-07
DePuy ATTUNE Rotating Platform Total Knee System Recalled for Damaged Packaging
DePuy Orthopaedics is recalling 355 units of the ATTUNE Rotating Platform Total Knee System due to potential damaged packaging. The affected tibial bases are used in cemented total knee arthroplasty.
Product
The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1314-2021·2021-04-07
DePuy ATTUNE Knee Implant Recall for Damaged Packaging
DePuy Orthopaedics is recalling ATTUNE and MBT tibial base components used in knee replacements due to potential damaged packaging.
Product
ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1326-2021·2021-04-07
Philips SureSigns Patient Monitors Recalled for Pediatric Heart Rate Accuracy Issues
Philips is recalling SureSigns VM4, VM6, and VM8 patient monitors in China because they fail to meet Chinese standards for heart rate accuracy in pediatric mode.
Product
Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1310-2021·2021-04-07
Arthrex Recalls Cannulated Drill Bits Due to Incorrect Color Indicator
Arthrex, Inc. is recalling 9 units of 5.0 mm cannulated drill bits because the color indicator on the shaft is the incorrect color.
Product
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Category
Medical Device
Distribution
Distributed nationwide

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14851–14875 of 39988