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 the agency’s own highest classification or reported deaths or serious injuries, 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

13151–13175 of 27471

HighFDA (Devices)·Z-2807-2020·2020-08-26
Chembio DPP COVID-19 IgM/IgG System Recalled for Performance Issues
Chembio Diagnostics is recalling 7,674 kits of the DPP COVID-19 IgM/IgG System because the FDA revoked its Emergency Use Authorization due to performance issues.
Product
Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2818-2020·2020-08-26
Smith & Nephew Recalls Single RIKKI Retractors Due to Improper Heat Treatment
Smith & Nephew is recalling 111 units of Single RIKKI Retractors because they were improperly heat treated. The devices are used during surgery to hold soft tissue away from the surgical site.
Product
Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2815-2020·2020-08-26
Whirlpool Recalls Powered Air-Purifying Respirators Due to Loose Headband Risk
Whirlpool is recalling 528 powered air-purifying respirators because rivets may be mis-assembled, allowing the face shield to detach and fall on the user.
Product
PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2817-2020·2020-08-26
Golden Technologies Lift Chair Recalled for Suspected Poor Weld
Golden Technologies is recalling 251 Model PR515 Lift Chairs due to a suspected poor weld on the back KD bar.
Product
Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2794-2020·2020-08-19
Philips HeartStart MRx Monitor/Defibrillators Recalled for Therapy Switch Failure
Philips is recalling HeartStart MRx monitor/defibrillators because a therapy switch failure may prevent the device from delivering the intended shock energy or function.
Product
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2795-2020·2020-08-19
Bioseal Trachea Extenders Recalled for Stress Cracks and Leakage Risk
Bioseal Corporation is recalling 900 units of Trachea Extenders due to stress cracks that may cause breathing system leakage, potentially preventing prescribed ventilation from reaching patients.
Product
Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2780-2020·2020-08-19
Maquet Holder HKHZ 19 Recalled for Insecure Oxygenator Fit
Maquet is recalling Holder HKHZ 19 units for Quadrox-i and Quadrox-iD oxygenators because the holder may not securely hold the oxygenator.
Product
Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2775-2020·2020-08-19
Luminex Verigene Processor SP Recalled for Potential False Negative Results
Luminex is recalling Verigene Processor SP systems because an instrument failure may cause false negative results for Gram-positive and Gram-negative blood culture tests.
Product
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2773-2020·2020-08-19
Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems
Ion Beam Applications is recalling four Proteus 235 Proton Therapy Systems because a software defect prevents users with long names from resuming interrupted treatments.
Product
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2778-2020·2020-08-19
Anjon Holdings Recalls Spinal Bone Fixation Fasteners Due to Galling
Anjon Holdings is recalling 249 Anjon Bremer Molded Crown bone fixation fasteners because of a high rate of galling in a threaded component.
Product
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2770-2020·2020-08-19
Ortho VITROS Anti-SARS-CoV-2 Reagent Recalled for Potential False Negatives
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total Reagent because swapped bottles may cause false negative or delayed results.
Product
VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2799-2020·2020-08-19
United Imaging Recalls uEXPLORER PET/CT System for Potential Sharp Edges
Shanghai United Imaging Healthcare is recalling one uEXPLORER PET/CT Diagnostic Imaging System in Texas due to potential sharp edges and image data issues.
Product
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2774-2020·2020-08-19
Smith & Nephew Recalls Tibial Knee Prosthesis Due to Material Defects
Smith & Nephew is recalling 1,845 tibial knee prostheses because raw material inconsistencies may cause internal non-homogenous material defects.
Product
Tibial knee prosthesis
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-2800-2020·2020-08-19
United Imaging Recalls uMI 550 PET/CT Systems Due to Imaging and Safety Defects
Shanghai United Imaging Healthcare is recalling four uMI 550 PET/CT systems due to defects that may cause image artifacts, scanning interruptions, or sharp edges.
Product
uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2785-2020·2020-08-19
Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage
Flower Orthopedics is recalling 25 calcaneus plates because the contract manufacturer used a titanium alloy instead of pure titanium.
Product
Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2771-2020·2020-08-19
Ortho Clinical Diagnostics Recalls VITROS Anti-SARS-CoV-2 IgG Reagent Packs
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Reagent Packs because swapped reagent bottles may cause false negative or delayed results.
Product
VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2776-2020·2020-08-19
Luminex Verigene Processor SP Recalled for Potential False Negative Results
Luminex is recalling Verigene Processor SP systems because an instrument failure may cause false negative results in blood culture tests.
Product
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2793-2020·2020-08-19
Brainlab Kick Navigation Station Recalled for Incorrect Calibration
Brainlab AG is recalling 9 Kick navigation stations due to incorrect manufacturer calibration. The units were distributed in the US and internationally.
Product
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
Category
Medical Device
Distribution
3 states
CriticalFDA (Devices)·Z-2734-2020·2020-08-12
Smiths Medical Medfusion Syringe Pump Recall for Inaccurate Dose Delivery
Smiths Medical is recalling Medfusion Syringe Pump Model 4000 units due to a risk of inaccurate drug delivery following interrupted bolus or loading doses.
Product
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2716-2020·2020-08-12
CareFusion Alaris System PC Unit Model 8000 Recall for Cleaning Agent Damage
CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8000 infusion pumps because cleaning agents may damage connectors, causing therapy interruptions.
Product
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2768-2020·2020-08-12
Beacon EUS Access System Needle Recalled Due to Cannula Detachment
Covidien is voluntarily recalling 375 units of the Beacon EUS Access System Preloaded Access 90-degree Needle because the cannula may detach during procedures.
Product
Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2758-2020·2020-08-12
Siemens Ysio Max X-Ray System Recalled for Software Defects
Siemens Medical Solutions is recalling 512 Ysio Max X-ray systems due to software issues that may cause collisions or incorrect diagnostic images.
Product
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2750-2020·2020-08-12
GE Healthcare Recalls CARESCAPE ONE Monitors Due to Alarm Failure Risk
GE Healthcare is recalling 8,414 CARESCAPE ONE patient monitors because they may fail to provide visual and audible alarms for Ventricular Fibrillation when docked to specific host monitors.
Product
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2769-2020·2020-08-12
Beacon EUS Access System Needle Recalled Due to Cannula Detachment
Covidien is voluntarily recalling 269 Beacon EUS Access System needles because the cannula detached during procedures in three reported cases.
Product
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2723-2020·2020-08-12
CareFusion Alaris Auto ID Module Recall Due to Cleaning Agent Damage
CareFusion is recalling Alaris Auto ID Modules because cleaning agents may damage connectors, causing infusion interruptions and therapy stops.
Product
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide

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13151–13175 of 27471