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

1201–1225 of 1396

SevereFDA (Devices)·Z-1485-2022·2022-08-17
Cobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy
Medtronic's Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. Patients with affected models should contact their physician.
Product
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1400-2022·2022-08-17
Viral Transport Container Distributed Without FDA Clearance or Guidance Compliance
Haimen Shengbang Laboratory Equipment recalled 100,000 viral transport containers distributed without FDA clearance and outside FDA guidance, affecting facilities in California, Florida, Illinois, New York, and China.
Product
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1489-2022·2022-08-17
Crome Implantable Cardioverter Defibrillators Recalled for Reduced Shock Energy
Medtronic is recalling 1,657 Crome implantable cardioverter defibrillators due to potential reduced shock energy during high-voltage therapy. Affected devices may deliver only 79% of programmed energy.
Product
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1488-2022·2022-08-17
Cobalt Implantable Defibrillators May Deliver Reduced Shock Energy
Medtronic Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. The reduced energy could affect device performance in patients requiring defibrillation.
Product
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1401-2022·2022-08-10
SARS-CoV-2 Rapid Antigen Test Kits Distributed Without FDA Approval
North American Diagnostics is recalling SARS-CoV-2 rapid antigen test kits that were distributed without FDA approval or clearance. Approximately 122,366 units were sold to consumers across multiple US states and internationally.
Product
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1397-2022·2022-08-03
BD Intraosseous Needle Kits recalled for mechanical failure and safety defects
BD Intraosseous Needle Kits have been recalled due to mechanical failures that could prevent emergency vascular access. Affected units nationwide and in Canada may experience stylet removal problems, safety mechanism failures, or driver malfunction.
Product
Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga, D015251NK/ BD Needle Kit for Powered Driver 25mm x 15Ga, D015251MK/ BD Manual Driver Needle Kit 25mm x 15Ga, D
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1376-2022·2022-08-03
ABACUS TPN Calculation Software recalled for medication error risk
Baxter Healthcare's ABACUS TPN calculation software poses a potential risk of medication error. The FDA issued a Class I recall; healthcare providers should contact the manufacturer for guidance.
Product
ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE), 8300-3
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1395-2022·2022-08-03
CereLink ICP Monitor recalled for out-of-range pressure readings
Integra LifeSciences is recalling CereLink ICP Monitors due to electrical interference causing intracranial pressure readings to drift out of range. Affected devices may display an error message indicating sensor or extension cable failure.
Product
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1389-2022·2022-07-27
GE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
GE Healthcare anesthesia systems may have reversed oxygen and air transducer connections, potentially affecting proper gas delivery. 5,372 devices worldwide are affected.
Product
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1349-2022·2022-07-20
CoolCurve+ Vacuum Applicator Recalled for Increased Paradoxical Hyperplasia Reports
Zeltiq Aesthetics is voluntarily recalling CoolCurve+ ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia during 2019–2021, an adverse event involving abnormal fat growth at treatment sites.
Product
CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
Category
Medical Device
Distribution
52 states
CriticalFDA (Devices)·Z-1319-2022·2022-07-13
Palindrome HSI Chronic Catheter Recalled for Potential Hub Leaking
Covidien is recalling Palindrome HSI Chronic Catheters due to a potential leaking condition in the catheter hub that may cause unanticipated fluid return during dialysis. Approximately 13,526 units distributed worldwide are affected.
Product
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1320-2022·2022-07-13
Dialysis Catheters Recalled for Potential Fluid Leakage from Hub Defect
Covidien is recalling Mahurkar Chronic Carbothane dialysis catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during use. Approximately 132,443 units distributed worldwide are affected.
Product
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1315-2022·2022-07-13
Palindrome Precision Chronic Dialysis Catheters Risk Fluid Leakage Due to Hub Defect
Covidien recalls 25,765 Palindrome Precision HSI Chronic Catheters due to a defect in the hub that may cause unintended fluid leakage during dialysis treatment.
Product
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1317-2022·2022-07-13
Palindrome H Chronic Catheters Recalled for Potential Hub Leaking
Palindrome H Chronic Catheters are being recalled due to a potential leaking condition in the catheter hub that may result in unanticipated fluid return during hemodialysis treatment. Affected units have been distributed worldwide.
Product
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1316-2022·2022-07-13
Palindrome Chronic Catheter recalled due to potential hub leakage
Covidien is recalling Palindrome Chronic Catheters due to a potential leaking condition in the hub that may cause unexpected fluid return during use.
Product
Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1314-2022·2022-07-13
Palindrome Precision SI Chronic Catheters Recalled for Potential Hub Leaking
Covidien recalls Palindrome Precision SI chronic dialysis catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during use.
Product
Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1276-2022·2022-07-13
Clean Catch Urine Kit Recalled Due to Improper Assembly
American Contract Systems is recalling 274,400 Clean Catch Urine Kits due to improper assembly by potentially untrained individuals. The FDA classified this as a Class I recall.
Product
Clean Catch Urine Kit NS 178489, AHMU58A
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1313-2022·2022-07-13
Palindrome Precision H Chronic Catheter Recalled for Potential Hub Leakage
Covidien is recalling certain Palindrome Precision H Chronic Catheters because the hub may leak, causing unexpected fluid to flow back during use. This FDA Class I recall affects 26,675 units distributed globally.
Product
Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1277-2022·2022-07-13
COVID-19 nasopharyngeal sample collection tray recalled due to improper assembly
American Contract Systems, Inc. recalls 274,400 COVID-19 test kits distributed in Minnesota due to off-site assembly by individuals who may not have been properly trained.
Product
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1312-2022·2022-07-13
Palindrome Precision Chronic Dialysis Catheter Hub Leak Risk
Palindrome Precision Chronic Catheters used for dialysis may leak due to a flaw in the hub component, potentially allowing unintended fluid to escape during treatment.
Product
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1278-2022·2022-06-29
Anesthesia System Suction Switch Crack Recall: Potential Equipment Failure
Getinge is recalling 17 Flow-c Anesthesia Systems due to cracks that may develop on the suction unit's on/off switch, potentially preventing the switch from activating and posing a risk to patients.
Product
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1266-2022·2022-06-29
HeartWare HVAD Battery Model 1650DE May Malfunction Due to Weld Defect
Medtronic is recalling HeartWare HVAD batteries (Model 1650DE) due to an internal weld defect that can cause battery malfunction and prevent proper charging. Approximately 429 affected batteries were distributed worldwide.
Product
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1271-2022·2022-06-29
Medfusion Syringe Pump Recalled Due to Multiple Infusion Control and Alarm Failures
Smiths Medical recalled 58,671 Medfusion Syringe Pump units worldwide due to multiple failures that could interrupt therapy or cause over-infusion, including defective alarms and display errors.
Product
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1279-2022·2022-06-29
Anesthesia system suction switch may crack and fail to activate
Getinge Flow-e Anesthesia System units may have a crack forming on the suction unit's on/off switch, which could break and prevent the suction from being activated, potentially harming patients.
Product
Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1272-2022·2022-06-29
Medfusion Syringe Pump Class I Recall: Risk of Over-Infusion or Therapy Interruption
Smiths Medical is recalling multiple Medfusion Syringe Pump models due to software and hardware defects that may interrupt drug infusion or cause over-infusion. Approximately 65,093 units distributed worldwide are affected.
Product
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, S
Category
Medical Device
Distribution
Distributed nationwide

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1201–1225 of 1396