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

7876–7900 of 27393

HighFDA (Devices)·Z-1975-2023·2023-06-28
Serrated Blade Applicator Kit packaging may contain wrong applicator size
Packaging for Helena Laboratories' Serrated Blade Applicator Kit (REF 552687) may contain the wrong applicator size (18-sample instead of 12-sample), causing incorrect or delayed diagnostic results in laboratory testing.
Product
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1991-2023·2023-06-28
Karl Storz Sterilization Trays Recalled Due to Inadequate Instructions
Karl Storz Endoscopy is recalling approximately 4,933 metal sterilization trays distributed worldwide. The trays were provided with instructions for use that were not specific to individual tray models regarding sterilization methods.
Product
Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Metal Tray, 275 x 175 x 37 mm, REF: 11580D; Wire Tray f. Cleaning, 290x60x52mm, REF: 39501A1; Wire Tray f. Cleaning, 352 x 125 x 54 mm, REF: 39
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1667-2023·2023-06-21
Nitric Oxide Delivery System check valve misalignment risk
NOxBOXi Nitric Oxide Delivery System devices may malfunction due to misaligned check valves, risking gas leaks and therapy interruption. This could lead to oxygen desaturation if the device fails during patient use.
Product
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1912-2023·2023-06-21
Aspira Pleural Drainage Catheter Insertion Tray recalled for valve assembly malfunction
Merit Medical Systems is recalling the Aspira Pleural Drainage Catheter Insertion Tray because valve assemblies may not open, preventing proper fluid drainage.
Product
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1824-2023·2023-06-21
External Fixation System Post Component Recall Due to Thread Stripping
New Standard Device Inc is recalling 222 units of 'n'-Hole Posts used in the Revolution External Fixation System because the threads strip out during tensioning, potentially compromising fracture fixation.
Product
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1702-2023·2023-06-21
Eye and Ear Dropper Recalled for Potential Glass Particulate Contamination
Apothecary Products is recalling Eye and Ear Droppers (Product Code 67082) due to the potential for glass particulate on the dropper bulb's external surface. Consumers should stop using affected units immediately.
Product
Eye and Ear Dropper, Product Code 67082
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1967-2023·2023-06-21
bellavista 1000e Ventilator Software May Hang, Affecting Device Interface
Vyaire Medical is recalling certain bellavista 1000e ventilators due to software issues that may cause the touchscreen to become unresponsive. The recall also addresses potential operator error risks if ventilator settings are not confirmed before application.
Product
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1917-2023·2023-06-21
Aspira Drainage Catheter Insertion Tray May Have Non-Opening Valve
Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly malfunction that could prevent fluid drainage.
Product
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1969-2023·2023-06-21
Tearaway Introducer Set Recall Due to Potential Luer Connection Failure
Galt Medical Corporation is recalling Tearaway Introducer Sets due to potential cracks or dislodgement of the luer connection during use. The defect, linked to improper storage conditions, could render the device unusable.
Product
Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1921-2023·2023-06-21
Exeter V40 Trial Head 26mm -3 Color Mislabeling
An orthopedic trial component may have incorrect color labeling. The Exeter V40 Trial Head (26mm, -3) may appear green when it should be blue. Two units distributed in Ireland.
Product
Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1920-2023·2023-06-21
Aspira Drainage Catheter Insertion Tray valve assembly may fail to open
Merit Medical Systems is recalling certain Aspira Drainage Catheter Insertion Trays (Model 15.5F) due to a potential valve assembly defect that could prevent fluid drainage. No injuries have been reported.
Product
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1918-2023·2023-06-21
Aspira Drainage Catheter Tray Recalled for Potential Valve Malfunction
Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly failure that may prevent fluid drainage. No injuries have been reported.
Product
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1908-2023·2023-06-21
Aspira Peritoneal Drainage Catheter Insertion Tray Valve Malfunction Recall
Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays due to a potential valve assembly malfunction that could prevent fluid drainage. No injuries have been reported.
Product
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1970-2023·2023-06-21
SteriPack Sterile Polyester Spun Swabs recalled due to breakage risk
LumiraDx recalled 1,003 kits of SteriPack Sterile Polyester Spun Swabs due to failed post-sterilization testing. Swabs may break in the nasal cavity, potentially causing injury or requiring medical intervention to remove fragments.
Product
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1914-2023·2023-06-21
Aspira Pleural Drainage Catheter trays recalled for valve failure
Merit Medical Systems recalls Aspira Pleural Drainage Catheter Insertion Trays because valve assemblies may not open, preventing fluid drainage. The recall affects 436 units distributed nationwide and internationally.
Product
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1913-2023·2023-06-21
Aspira Pleural Drainage Catheter May Fail to Drain Fluid
Merit Medical Systems is recalling 524 units of the Aspira Pleural Drainage Catheter Insertion Tray due to a defect where valve assemblies may not open, preventing fluid drainage. Affected units were distributed worldwide including across the US, France, UK, and Mexico.
Product
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1910-2023·2023-06-21
Aspira Peritoneal Drainage Catheter Insertion Tray valve malfunction
Merit Medical's Aspira Peritoneal Drainage Catheter Insertion Tray valve assemblies may fail to open, preventing fluid drainage. 175 units distributed nationwide and internationally are affected.
Product
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1919-2023·2023-06-21
Aspira Drainage Catheter Insertion Tray recalled due to valve malfunction
Merit Medical Systems is recalling Aspira Drainage Catheter Insertion Tray 15.5F due to potential valve assembly failure that may prevent fluid drainage. No injuries reported.
Product
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1693-2023·2023-06-21
p-Chip Wand Reader Recalled for Laser Classification Safety Issue
FDA is recalling 329 p-Chip Wand Reader units due to laser operation potentially exceeding its classified safety level. Affected models are WA-4000, WA-4500, WA-8000, and WA-8500 distributed nationwide.
Product
p-Chip Wand Reader
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1915-2023·2023-06-21
Aspira Pleural Drainage Catheter Insertion Tray recalled due to valve failure
Merit Medical Systems recalls the Aspira Pleural Drainage Catheter Insertion Tray due to a potential valve failure that could prevent fluid drainage. The recall affects approximately 1054 units distributed nationwide and internationally.
Product
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1916-2023·2023-06-21
Aspira Valve Repair Kit may fail to open and obstruct fluid drainage
Merit Medical Systems is recalling Aspira Valve Repair Kits because valve assemblies may fail to open, preventing fluid drainage. The FDA Class II recall affects 2,559 units distributed across the US and internationally.
Product
Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1966-2023·2023-06-21
bellavista 1000 Ventilator Recalled for Software Hang and Use Error Risk
Vyaire Medical is recalling approximately 910 units of the bellavista 1000 Ventilator due to a software issue that can cause the touchscreen to become unresponsive and a potential use error risk if operators do not confirm settings are appropriate for the patient.
Product
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1825-2023·2023-06-21
Philips Tempus LS-Manual Defibrillator pacing failure due to communication error
A communication failure in the Philips Tempus LS-Manual Defibrillator may prevent pacing delivery. The device displays an error message and potentially becomes ineffective, affecting approximately 1,147 units distributed nationwide.
Product
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1972-2023·2023-06-21
Driver Instrument May Break During Surgery, Leaving Metal Fragments
The Superion Indirect Decompression System's driver instrument may fracture during implantation if excessive force is applied, potentially leaving metal fragments in the surgical site. Retained fragments contraindicate MRI scans.
Product
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1703-2023·2023-06-21
Medicine Dropper Recalled for Potential Glass Particulate Contamination
Apothecary Products, LLC is recalling 1,596 units of Medicine Dropper (Lot 021623) due to potential glass particles on the dropper bulb exterior. Glass particles could contaminate medication or cause injury.
Product
Medicine Dropper, Product Code K508
Category
Medical Device
Distribution
Distributed nationwide

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7876–7900 of 27393