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

1376–1396 of 1396

SevereFDA (Devices)·Z-1974-2021·2021-07-21
Philips Respironics ventilators recalled for degrading foam and chemical hazards
Philips Respironics ventilators are recalled because foam components may degrade and release particles and chemicals that patients could inhale.
Product
SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1972-2021·2021-07-21
Philips Respironics E30 ventilator foam degradation poses inhalation hazard
Philips Respironics E30 ventilators may have polyurethane foam that degrades into particles. These particles can enter the air pathway and be inhaled or ingested by patients, or the foam may off-gas chemicals.
Product
Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for indiv
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1954-2021·2021-07-07
LeadCare Ultra Blood Lead Test Kit Recalled for Control Test Inaccuracy
Magellan Diagnostics is recalling the LeadCare Ultra Blood Lead Test Kit due to control test failures causing potential underestimation of blood lead levels in patient samples. The recall involves 441 kits with worldwide distribution.
Product
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1953-2021·2021-07-07
Blood Lead Test Kit Recalled for Inaccurate Control Test Results
Magellan Diagnostics recalls LeadCare Plus Blood Lead Test Kit after control tests generated low results, potentially underestimating patient blood lead levels. Affected lot numbers include 2011MU, 2104MU, and 2108MU.
Product
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1952-2021·2021-07-07
LeadCare II Blood Lead Test Kit Control Test Inaccuracy Recall
The LeadCare II Blood Lead Test Kit may generate artificially low control test results, causing blood lead levels to be underestimated in patient samples. Kits were distributed worldwide.
Product
LeadCare II Blood Lead Test Kit Catalog Number 70-6762
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1863-2021·2021-06-30
Nitric Oxide Delivery System Dosing Deficiency During Console Transitions
GENOSYL DS Nitric Oxide Delivery System is recalled for delivering below-intended doses during transitions between primary and backup consoles following a software update.
Product
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1860-2021·2021-06-23
Medtronic Angiographic Guidewire Components Shipped Without Required Sterilization
Medtronic Vascular recalled 54,997 angiographic guidewire components that were shipped directly to customers without the required downstream processing and sterilization. The components should have been sent to a third-party processor first.
Product
Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use fo
Category
Medical Device
Distribution
11 states
CriticalFDA (Devices)·Z-1786-2021·2021-06-16
Medical Convenience Kits Recalled Due to Mold Contamination Risk
Avid Medical is recalling 160 fistula care kits due to potential contamination from Aspergillus penicillioides fungal growth in a component applicator. The contamination could breach the kit's package integrity and affect other sterile components.
Product
FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1832-2021·2021-06-16
DeRoyal Pacemaker Tray Mislabeled With Wrong Anesthetic Concentration
DeRoyal is recalling surgical procedure packs due to mislabeling. The product contains 0.5% Bupivacaine but is labeled as 1% Lidocaine, creating a medication identification error.
Product
DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1798-2021·2021-06-16
Jelco Insulin Syringe Graduation Markings Recalled for Skew Defect
Smiths Medical recalls 1,432,200 Jelco insulin syringes with skewed graduation markings that could lead to incorrect dosing. Specific lot numbers are affected.
Product
JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1834-2021·2021-06-16
Surgical procedure pack anesthetic mislabeled with wrong drug and strength
DeRoyal Angio Cath Removal Tray contains mislabeled anesthetic; the label indicates 1% Lidocaine but the tray actually contains 0.5% Bupivacaine. This FDA Class I recall affects 60 trays distributed in MS, VA, LA, and NY.
Product
DeRoyal Angio Cath Removal Tray, REF 89-9936.02
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1785-2021·2021-06-16
Avid Medical Fistula On-Off Kit Recalled for Potential Fungal Contamination
Avid Medical is recalling 720 Fistula On-Off Kits due to potential fungal contamination that may compromise package integrity. The BD ChloraPrep applicator component may develop Aspergillus penicillioides, which could contaminate other kit components.
Product
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1787-2021·2021-06-16
Dialysis access kits recalled for potential fungal contamination risk
Avid Medical is recalling medical dialysis access kits due to potential fungal growth in an applicator component that may compromise the package seal and contaminate other components. Approximately 560 kits distributed nationwide are affected.
Product
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1833-2021·2021-06-16
DeRoyal Heart Cath Procedure Packs Recalled for Anesthetic Mislabeling
DeRoyal Industries is recalling 66 heart catheterization procedure packs due to mislabeling of anesthetic contents. The packs contain 0.5% Bupivacaine but are labeled as containing 1% Lidocaine, creating a medication error risk during surgery.
Product
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1784-2021·2021-06-16
Adult Chest Tube Tray Recalled Due to Package Integrity Risk
Avid Medical is recalling 130 Adult Chest Tube Trays due to potential contamination from mold growth in a component. The BD ChloraPrep applicator may grow Aspergillus penicillioides, which could breach package integrity and contaminate other kit components.
Product
ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1539-2021·2021-06-16
COVID-19 Self-Test Kit Distributed Without Clinical Investigation Authorization
Innova Medical Group recalled COVID-19 self-test kits distributed to customers outside of clinical investigation requirements. About 1,206 tests in 402 boxes were distributed across the U.S., Canada, India, and the United Kingdom.
Product
COVID-19 Self-Test Kit *** INNOVA *** 3T
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1538-2021·2021-06-16
INNOVA SARS-CoV-2 Antigen Rapid Tests Recalled for Unauthorized Non-Clinical Distribution
INNOVA Medical Group is recalling SARS-CoV-2 antigen rapid test kits distributed to customers not enrolled in an authorized clinical investigation.
Product
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1537-2021·2021-06-16
FDA Recalls Innova COVID-19 Self-Test Kits Due to Unauthorized Distribution
Innova Medical Group is recalling COVID-19 self-test kits distributed to customers outside an authorized clinical investigation. The recall affects 370 boxes of tests distributed nationwide and internationally.
Product
COVID-19 Self-Test Kit *** INNOVA *** 7T
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1651-2021·2021-06-09
Alaris Infusion Pump Module Bezel Repair Parts Recalled for Separation Risk
FDA recalls 22 serviced Alaris Model 8100 infusion pump units with bezel components that may crack or separate, risking free flow, over-infusion, under-infusion, or treatment interruption. Units distributed to Indiana and Texas between September 2020 and February 2021.
Product
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1619-2021·2021-06-09
Leccurate COVID-19 Antibody Test Kit Recalled for Unauthorized U.S. Distribution
LEPU Medical has recalled the Leccurate SARS-CoV-2 Antibody Rapid Test Kit because it is not authorized, cleared, or approved for marketing in the U.S. Approximately 8.4 million units have been distributed worldwide.
Product
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adapti
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1620-2021·2021-06-09
Leccurate SARS-CoV-2 Antigen Test Kit Recalled: Not FDA-Approved for U.S. Distribution
The Leccurate SARS-CoV-2 Antigen Rapid Test Kit is being recalled because it was not authorized, cleared, or approved for marketing in the United States. Approximately 8.4 million units were distributed worldwide, including to U.S. states and territories.
Product
Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).
Category
Medical Device
Distribution
4 states

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1376–1396 of 1396