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

13626–13650 of 13802

HighFDA (Devices)·Z-1899-2021·2021-06-23
VENOVO 9F Venous Stent System incomplete deployment and delivery system retention
Bard Peripheral Vascular recalls VENOVO Venous Stent System 9F due to reports that the proximal end fails to expand immediately upon deployment and remains connected to the delivery system.
Product
VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL14060 /Venovo 9F 14/60/1200mm OUS; VENEL14080 /Venovo 9F 14/80/1200mm OUS; VENEL14100 /Venovo 9F 14/100/1200mm OUS; VENEL14120 /Venovo 9F 14/120/1200mm OUS; VEN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1893-2021·2021-06-23
Medtronic Custom Perfusion System Tubing Packs Recalled Due to Welding Defects
Medtronic is recalling 26 tubing packs from its Custom Perfusion System (Lot 221148857) due to potential manufacturing defects. Specific lots may have been manufactured with insufficient or incomplete welds.
Product
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1872-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled Due to Weld Defects
Medtronic recalls specific lots of HY8M63R4 Adult ECC Custom Perfusion System tubing packs due to potentially insufficient or incomplete welds, which could affect performance during surgical procedures.
Product
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1895-2021·2021-06-23
Medtronic Neonatal Perfusion System Tubing Sets Recalled for Incomplete Welds
Medtronic is recalling 7 neonatal perfusion system tubing sets manufactured under lot 221387901 with insufficient or incomplete welds. The affected sets were distributed nationwide across nine states.
Product
Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1853-2021·2021-06-23
WorkMate Claris Cardiac Monitoring System Software Error Causes Loss of Functionality
Abbott's WorkMate Claris cardiac monitoring system may lose functionality or display a black screen during operation due to a software error affecting 4 distributed units.
Product
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1888-2021·2021-06-23
Medtronic Perfusion System Tubing Packs Recalled for Defective Welds
Medtronic is recalling CB10R55R5 perfusion system tubing packs due to insufficient or incomplete welds that could compromise device function. The recall affects five tubing packs distributed across nine U.S. states.
Product
Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1864-2021·2021-06-23
GE Healthcare X-Ray Systems Affected by Display Image Distortion Defect
GE Healthcare interventional x-ray imaging systems can develop a display defect that splits and distorts live monitor images into two unequal parts. The defect affects 139 devices with worldwide distribution.
Product
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1862-2021·2021-06-23
Better-Bladder ECMO Device May Collapse, Reducing Blood Flow
The Better-Bladder ECMO device used in cardiopulmonary bypass circuits may collapse during use, increasing venous line resistance and reducing blood flow. The recall affects 147 units distributed nationwide.
Product
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1869-2021·2021-06-23
HME for Tracheostomized Patients Recalled Due to Sterilization Process Deviations
Covidien LP is recalling HME (Heat and Moisture Exchanger) units for tracheostomized patients due to potential deviations from validated ethylene oxide sterilization parameters. The recall affects 10,890 units distributed worldwide and in specific U.S. states.
Product
HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1859-2021·2021-06-23
Dialysate Concentrate for Hemodialysis Recalled for Out-of-Specification Formulation
Medivators, Inc. recalls 1,381 cases of dialysate concentrate due to a manufacturing anomaly that may result in out-of-specification formulation. Affected lots may not function properly in hemodialysis treatment.
Product
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1865-2021·2021-06-23
ACUVUE VITA soft contact lenses recalled for potentially incomplete packaging seals
Johnson & Johnson Vision Care is recalling certain ACUVUE VITA soft contact lenses due to potential incomplete packaging seals. Only a limited number of packages from LOT # BOOWWWL are affected.
Product
ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50
Category
Medical Device
Distribution
Distributed nationwide
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-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
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-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-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-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-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-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-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
HighFDA (Devices)·Z-1846-2021·2021-06-16
Radiotherapy positioning software may delay patient movement display
Brainlab's ExacTrac Dynamic radiotherapy positioning software may delay display of patient movement during high-dose treatments, risking treatment precision errors. 22 systems affected across 11 U.S. states.
Product
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1821-2021·2021-06-16
Anterior Cervical Plate System Screw Blocking Mechanism May Disassociate
Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism. The screws may disassociate or unlock during or after surgery, risking implant failure.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1794-2021·2021-06-16
WishBone Medical Plate and Screw System Engineering Specification Nonconformity Recall
Wishbone Medical is recalling WishBone Medical Plate and Screw System implants due to nonconformities in engineering specifications. The recall affects 60 units distributed in Virginia, Pennsylvania, and Indiana.
Product
WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US
Category
Medical Device
Distribution
3 states

How to read this listing

Filters

13626–13650 of 13802