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

3551–3575 of 27346

HighFDA (Devices)·Z-0738-2025·2025-01-01
Siemens Blood Analysis System Software Malfunction May Cause Patient Identification Error
Siemens epoc NXS Host blood analysis systems are recalled due to a software malfunction that can assign incorrect patient names to blood tests, potentially leading to misdiagnosis or mistreatment.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0732-2025·2025-01-01
Abbott Vascular Inflation Device May Leak During Cardiovascular Procedures
Abbott Vascular is recalling the 20/30 Priority Pack Accessory Kit w/Copilot inflation device used in cardiovascular procedures because it may leak at connection points, potentially causing air embolism.
Product
20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-0741-2025·2025-01-01
Siemens epoc blood analyzer software assigns incorrect patient names
Siemens epoc NXS blood analysis system has a software defect that can incorrectly assign patient names to blood test results, potentially causing misdiagnosis or mistreatment.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0739-2025·2025-01-01
Blood Analysis System Software Error Can Assign Wrong Patient Name
Siemens epoc NXS Host blood analysis devices have a software malfunction that may assign the wrong patient name to blood test results, potentially leading to misdiagnosis or mistreatment.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or ca
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0746-2025·2025-01-01
BD FACSLyric Flow Cytometer Power Supply May Fail During Use
BD FACSLyric flow cytometers are recalled for power supply failures that may prevent the device from powering on, risking specimen loss and potential respiratory effects from fume inhalation.
Product
Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0727-2025·2025-01-01
Cardiac troponin test reagent recalled for potential false results
Beckman Coulter recalls 2.1 million units of Access hsTnI reagent worldwide due to contamination causing falsely elevated troponin results in patient samples.
Product
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0724-2025·2025-01-01
Medline Surgical Patties and Strips Recalled for Out-of-Spec Endotoxin Contamination
Medline is recalling surgical patties and strips in custom surgical kits due to higher-than-expected endotoxin levels in raw materials. These may result in out-of-specification endotoxin levels in finished sterile products.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0748-2025·2025-01-01
BD FACSLyric Flow Cytometer Power Supply Module Failure Risk
BD is recalling power supply modules on FACSLyric flow cytometers that may fail to power on or stay on. Failure could cause lab staff to inhale fumes and patients to need repeat blood draws.
Product
FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath ta
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0767-2025·2025-01-01
Siemens magnesium reagent cartridges recalled for false measurement results
Siemens is recalling two lots of Magnesium Flex reagent cartridges due to potential falsely low magnesium measurements. The intermittent error may not be detected by standard quality control procedures.
Product
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0717-2025·2025-01-01
Surgical Patties and Strips Recalled for Endotoxin Contamination
Medline Industries recalls specific lots of surgical patties and strips in MAJOR NEURO PACK-LF Convenience kits due to higher-than-expected endotoxin levels detected in raw materials, which may have resulted in out-of-specification finished products.
Product
MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0758-2025·2025-01-01
Medline Reprocessed Bruns Curette Surgical Instruments Recalled for Weak Sterile Seals
Medline is recalling 21,440 reprocessed Bruns curettes due to weak sterile seals that may fail without user detection. This increases the risk of contamination and infection.
Product
ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0734-2025·2025-01-01
Blood Analysis System Recalled Due to Patient Name Assignment Software Error
Siemens is recalling the epoc NXS Host blood analysis system due to a software defect that can incorrectly assign patient names to test results, potentially causing misdiagnosis and mistreatment.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capill
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0733-2025·2025-01-01
Inflation Device for Cardiovascular Procedures Risk of Air Embolism from Potential Leak
Abbott Vascular inflation devices used in heart procedures may leak at connection points, potentially causing air embolism in patients.
Product
20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-0756-2025·2025-01-01
Medline Surgical Needle Holders Recalled for Sterility Compromise
Medline is recalling 21,440 surgical needleholders due to weak seals that may compromise sterility and increase risk of contamination and infection during surgical use.
Product
ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0757-2025·2025-01-01
Sterile Magill Forceps Recalled Due to Weak Seals and Contamination Risk
Medline has recalled Sterile Magill Forceps (Item No. 66790) due to weak seals that may compromise sterility. The defect affects approximately 21,440 units distributed nationwide.
Product
STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0725-2025·2025-01-01
Surgical Patties and Strips with Endotoxin Contamination in Medline Convenience Kits
Medline Industries is recalling surgical patties and strips in specific lots of KIT,SPINE LH Convenience Kits due to higher-than-expected endotoxin levels in raw materials. The contamination may result in out-of-specification endotoxin in finished sterile products.
Product
KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0760-2025·2025-01-01
RUMMELL Medline Medical Device Weak Seals Sterility Risk Recall
Medline RUMMELL units may have weak seals that could compromise sterility and increase infection risk. Approximately 21,440 units distributed nationwide are affected.
Product
RUMMELL, Medline Item No. ST006ST
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0694-2025·2025-01-01
Panther Fusion Assay Kit Recalled for Possible SARS-CoV-2 False Positives
Hologic is recalling specific lots of the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay due to potential false positive SARS-CoV-2 results. Users should verify positive results with an alternative testing method.
Product
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0751-2025·2025-01-01
Daytona Small Stature Locking Caps recalled for manufacturing defects
SeaSpine Orthopedics is recalling 92 Daytona Small Stature CoCr Locking Caps due to manufacturing defects that prevent proper component mating. The devices were distributed in seven U.S. states.
Product
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0723-2025·2025-01-01
Medline surgical patties and strips recalled for endotoxin contamination
Medline surgical patties and strips used in certain procedure convenience kits were found to contain higher-than-expected endotoxin levels that may exceed safety specifications. The affected kits were distributed nationwide and in Canada.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ61607A; 4) CRANIOTOMY PACK, SKU DYNJ66419C; 5) LYMPHATIC BYPASS PACK, SKU DYNJ69907;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0736-2025·2025-01-01
Siemens epoc Blood Analysis System Recalled for Patient Identification Software Error
Siemens is recalling epoc NXS Host blood analysis systems due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis and mistreatment if not verified by the user.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0731-2025·2025-01-01
Abbott Vascular inflation device may leak during cardiovascular procedures
Abbott Vascular is recalling 20/30 Priority Pack Accessory Kit inflation devices due to potential leaks that could cause air embolism during cardiovascular procedures.
Product
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-0742-2025·2025-01-01
Galaxy System bronchoscope power supply defect may injure lung tissue
Noah Medical's Galaxy System bronchoscope has defective power supply semiconductors that may fail during procedures, potentially causing pneumothorax or lung tissue injury when the scope is manually removed.
Product
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-0747-2025·2025-01-01
Medical Device Recall: BD FACSLyric Flow Cytometer Power Supply Failure Risk
BD is recalling power supply modules in FACSLyric flow cytometers that may fail to power on or remain powered. Failure could expose lab staff to fumes and cause patient specimen loss or delayed test results.
Product
FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tan
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0659-2025·2024-12-25
Nidek Disposable Bipolar Pencil Surgical Instruments Recalled for Tube Breakage Risk
Kirwan Surgical Products recalls Nidek Disposable Bipolar Pencil surgical instruments due to risk that the stainless-steel tube may break or detach during procedures.
Product
Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauteriza
Category
Medical Device
Distribution
Distributed nationwide

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3551–3575 of 27346