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

10001–10025 of 40095

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
HighFDA (Devices)·Z-1982-2023·2023-06-28
Medline TheraHoney Gel Wound Dressing Recalled for Sterilization Failure
Medline is recalling 851,328 units of TheraHoney Gel wound dressing due to inadequate sterilization. The manufacturer failed to augment the sterilization dose after an audit failure, violating ISO 11137 standards.
Product
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1983-2023·2023-06-28
Masimo RD Set TC-I SpO2 Adult Ear Sensor Recalled for Inaccurate Readings
Masimo Corporation is recalling 138,926 units of the RD Set TC-I SpO2 Adult Reusable Ear Sensor because the tip clip sensor may produce readings outside the manufacturer's accuracy specification.
Product
Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-1712-2023·2023-06-28
Implantable Cardioverter Defibrillators Recalled for Rare Therapy Delivery Failure
Certain Medtronic implantable defibrillators may fail to deliver high voltage therapy in rare cases due to a manufacturing defect. The recall affects approximately 61,404 units distributed worldwide.
Product
ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1976-2023·2023-06-28
NextSeq 550Dx sequencing instruments recalled for cybersecurity software vulnerability
Illumina is recalling 1,067 NextSeq 550Dx sequencing instruments due to a cybersecurity vulnerability in the Universal Copy Service software. The affected instruments have been distributed worldwide.
Product
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1988-2023·2023-06-28
Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures
Olympus is recalling QUICKCLIP PRO hemostatic clips due to deployment failures that could prevent proper function during GI procedures. Clip arms may fail to operate or clips may detach prematurely from tissue.
Product
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1981-2023·2023-06-28
KARL STORZ sterilization trays recalled for inadequate model-specific instructions
FDA recalls KARL STORZ sterilization trays (4,386 units) because instructions lacked model-specific details and sterilization modality information, risking improper device sterilization.
Product
KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1754-2023·2023-06-28
Implantable Cardiac Defibrillators May Deliver Reduced Energy Output
Certain Medtronic cardiac defibrillators may deliver reduced or no energy during high voltage therapy. No injuries or deaths have been reported.
Product
CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
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-1979-2023·2023-06-28
Hemospray Endoscopic Hemostat Recalled for Powder Adhesion Risk
Wilson-Cook Medical is recalling Hemospray Endoscopic Hemostat units (14,877 devices, US and worldwide distribution) because powder can adhere to the endoscope tip, potentially making removal difficult or impossible.
Product
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1990-2023·2023-06-28
Hemostatic Clip Device Recalled Due to Deployment Failures
Olympus recalls QUICKCLIP PRO hemostatic clips nationwide due to reported malfunction during clinical procedures, where clips fail to open, close, or detach from tissue as intended.
Product
Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1743-2023·2023-06-28
Implantable Defibrillators Recalled for Potential High-Voltage Therapy Failure
Medtronic CRT-D and ICD devices with a specific feedthrough may fail to deliver high-voltage therapy. The FDA Class I recall affects multiple lot numbers due to rare potential for reduced or no energy output during critical treatment.
Product
CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1987-2023·2023-06-28
Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures
Olympus is recalling 340 QUICKCLIP PRO hemostatic clips used in gastrointestinal endoscopy due to reports of deployment failures during procedures, including clips that fail to open, close, or detach properly.
Product
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1718-2023·2023-06-28
Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
Medtronic implantable cardiac defibrillators may deliver reduced or no energy during defibrillation therapy due to a feedthrough defect. Approximately 11,239 devices distributed worldwide are affected.
Product
ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1763-2023·2023-06-28
Implantable Cardiac Defibrillators at Risk of Therapy Delivery Failure
Medtronic implantable defibrillators may fail to deliver therapy due to a feedthrough defect. 2,173 affected units were distributed nationwide and worldwide.
Product
CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1980-2023·2023-06-28
V-Sign Sensor 2 May Experience Out-of-Box Failure Due to Software Configuration
The V-Sign Sensor 2, a component of the Sentec Digital Monitoring System, may fail out of the box due to improper software mode configuration after recalibration. Approximately 11 units were distributed in select U.S. states.
Product
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1993-2023·2023-06-28
HeartWare Ventricular Assist Device Monitor logfile processing failure
Heartware, Inc. is recalling 19 HeartWare Ventricular Assist Device System monitors (Model 1521 variants) because recently updated units cannot process downloaded logfiles in the Autologs web portal.
Product
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1977-2023·2023-06-28
FDA Recalls MiSeq Dx Instruments for Software Cybersecurity Vulnerability
Illumina recalls 740 MiSeq Dx sequencing instruments due to a software cybersecurity vulnerability affecting the Universal Copy Service component. No patient harm reported.
Product
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
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-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-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-1968-2023·2023-06-21
Tearaway Introducer Kit Recalled Due to Potential Connector Defect
Galt Medical Corporation is recalling Tearaway Introducer Kits due to potential cracking or dislodging of the luer connection during use, which can render the device unusable and require replacement.
Product
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
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-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

How to read this listing

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10001–10025 of 40095