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

1301–1325 of 1396

SevereFDA (Devices)·Z-0233-2022·2021-11-24
Arrow-Trerotola Percutaneous Thrombolytic Device inner lumen detachment and embolization risk
Arrow-Trerotola PTD catheters are being recalled because the inner lumen can detach from the device basket, causing embolization that requires additional intervention. 1,167 units are affected.
Product
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousf
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0224-2022·2021-11-24
FDA Recalls Scrip Ultrasound Gel for Potential Bacterial Contamination
Scrip Inc is recalling Scrip Ultrasound Gel Clear (5L) nationwide due to potential bacterial contamination. Affected units may cause harm if contaminated product contacts patients during ultrasound procedures.
Product
Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0225-2022·2021-11-24
Scrip Creme ultrasound lotion recalled for bacterial contamination
Scrip Creme All Purpose Lotion is being recalled due to bacterial contamination in this ultrasound coupling lotion. The product—1001 gallons in lots distributed between August 2018 and August 2021—was distributed nationwide.
Product
Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0231-2022·2021-11-24
Arrow-Trerotola Percutaneous Thrombolytic Device Inner Lumen Detachment Recall
The inner lumen of Arrow-Trerotola Over-The-Wire PTD catheters (7FR) can detach from the device, causing an embolism. This requires additional medical intervention and delays treatment.
Product
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0183-2022·2021-11-17
Ellume COVID-19 Home Test Recalled for Higher Rate of False Positives
Ellume recalled approximately 427,994 COVID-19 home test kits due to a higher rate of false positive results. The affected kits were distributed in Minnesota, New York, Pennsylvania, Rhode Island, Utah, and Washington.
Product
Ellume COVID-19 Home Test
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-0194-2022·2021-11-10
IPL Coupling Gel and EcoGel 200 Recalled for Bacterial Contamination
Lumenis, Inc. is recalling IPL Coupling Gel and EcoGel 200 due to potential bacterial contamination. Approximately 11,064 units were distributed worldwide.
Product
IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0119-2022·2021-11-10
Monoject Prefilled Syringe Plunger Defect Recall: Air Reintroduction Risk
Monoject prefilled syringes in medical kits may have a plunger that rebounds after air expulsion, potentially reintroducing air into the syringe. This FDA Class I recall affects approximately 9,378 units distributed in Florida and Pennsylvania.
Product
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Sp
Category
Medical Device
Distribution
2 states
CriticalFDA (Devices)·Z-0118-2022·2021-11-03
Surgical Brain Guidance System Recalled for Inaccurate Electrode Placement
ROSA One 3.1 surgical guidance system recalled due to a software anomaly causing inaccurate electrode placement during brain and spine surgery. Manufacturer received 3 complaints related to the issue.
Product
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0091-2022·2021-10-27
Cardiosave Li-Ion battery pack recalled for insufficient runtime specification
Datascope Corp. is recalling Cardiosave Li-Ion battery packs that failed to meet minimum runtime requirements. These nonconforming batteries were inadvertently released to customers worldwide.
Product
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 099
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0107-2022·2021-10-27
Infusion Pump Air Detector Malfunction May Prevent Alarm to Clinician
Smiths Medical CADD-Solis VIP ambulatory infusion pumps may fail to detect air in the infusion line and alert clinicians due to intermittent air-detector malfunction.
Product
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-01
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0008-2022·2021-10-20
Abbott Respiratory Diagnostic Kit Recalled for Potential False Positive Results
Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit due to potential false positive results. The recall affects 5,855 units distributed worldwide.
Product
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0007-2022·2021-10-20
Abbott Alinity m SARS-CoV-2 Test Kit Recalled for Potential False Positives
Abbott Molecular recalls its Alinity m SARS-CoV-2 Amp Kit (Non-US Assay), an in vitro diagnostic test, due to potential for false positive results. Approximately 11,408 units were distributed worldwide.
Product
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0004-2022·2021-10-20
Abbott SARS-CoV-2 Diagnostic Kit Recalled for Risk of False Positive Results
Abbott Molecular is recalling 60,563 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive test results. The affected kits were distributed worldwide from September 2021 through January 2023.
Product
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0005-2022·2021-10-20
Abbott Alinity m Resp-4-Plex Respiratory Diagnostic Kit Recalled for False Positive Results
Abbott is recalling the Alinity m Resp-4-Plex AMP Kit, an in vitro diagnostic used for respiratory pathogen testing, due to potential for false positive results affecting approximately 8,469 units distributed worldwide.
Product
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0089-2022·2021-10-20
FDA recalls Eco-Med ultrasound gels due to bacterial contamination risk
FDA recalls ultrasound gels manufactured by Eco-Med Pharmaceutical due to possible bacterial contamination. Healthcare providers and facilities should stop use immediately.
Product
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0088-2022·2021-10-20
Eco-Med Ultrasound Gel Recalled for Bacterial Contamination Risk
Eco-Med Pharmaceutical's ultrasound gel products are recalled due to potential bacterial contamination. The FDA advises healthcare providers to stop using the affected product.
Product
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0067-2022·2021-10-20
FDA Recalls Ultrasound Gels and Lotions for Potential Bacterial Contamination
Ultrasound gels and lotions from National Distribution & Contracting Inc are being recalled due to potential bacterial contamination. About 25,103 units distributed nationwide and in Canada are affected.
Product
ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0068-2022·2021-10-20
Ultrasound gel products recalled for potential bacterial contamination
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. Products distributed nationwide in the U.S., Canada, and other locations have been recalled.
Product
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0006-2022·2021-10-20
Abbott Alinity m SARS-CoV-2 Amp Kit Recalled for Potential False Positive Results
Abbott Molecular has recalled 71,314 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive results. The kit was distributed worldwide.
Product
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0090-2022·2021-10-20
FDA Recalls Ultrasound Gel for Possible Bacterial Contamination
Red Medical Supplies is recalling EcoGel 100 ultrasound gel due to possible bacterial contamination. Approximately 639 units were sold nationwide through Amazon.com.
Product
EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0010-2022·2021-10-13
FDA Recalls Ultrasound Gels and Lotions for Potential Bacterial Contamination
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical may contain bacterial contamination. The FDA has issued a Class I recall affecting 8,702 units distributed worldwide.
Product
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0009-2022·2021-10-13
Ultrasound gel distributed with medical devices recalled for bacterial contamination
Ultrasound gel manufactured by Eco-Med Pharmaceutical and distributed with various medical device kits may contain bacterial contamination. Users should stop using affected products and follow FDA guidance.
Product
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 20
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0029-2022·2021-10-13
Eco-Med Ultrasound Gels and Lotions Recalled for Bacterial Contamination
Eco-Med Pharmaceutical's ultrasound gels and lotions are recalled for potential bacterial contamination. The FDA advises health care providers to stop using all affected products.
Product
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2582-2021·2021-10-06
Ultrasound Gel Products Recalled for Possible Bacterial Contamination
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. The FDA recommends healthcare providers stop using these products immediately.
Product
Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North Coas
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2592-2021·2021-10-06
Atrium Pneumostat Chest Drain Valve Recalled Following Fatal Preterm Infant Case
Atrium Medical Corporation is recalling 92,430 units of its Pneumostat Chest Drain Valve after a preterm infant died during treatment with the device. The company is revising product labeling and warnings.
Product
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Category
Medical Device
Distribution
Distributed nationwide

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1301–1325 of 1396