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

15776–15800 of 40287

HighFDA (Devices)·Z-0564-2021·2020-12-23
FDA Recalls Tempus LS Manual Defibrillators Due to Software Error
Remote Diagnostic Technologies is recalling 175 Tempus LS manual defibrillators because a software error may delay therapy by disrupting ECG calibration.
Product
Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0590-2021·2020-12-23
Enterix Recalls InSure ONE Test Strips Due to Potential False Positives
Enterix, Inc. is recalling InSure ONE Test Strips because they may produce false positive results, potentially leading to unnecessary medical procedures.
Product
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0589-2021·2020-12-23
RaySearch Recalls RayStation and RayPlan Software Due to Treatment Plan Errors
RaySearch is recalling RayStation and RayPlan software versions due to potential errors in treatment plan reports, including incorrect dose information and couch angles.
Product
RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0569-2021·2020-12-23
Ra Medical Systems Recalls DABRA Laser Due to Footswitch Defect
Ra Medical Systems is recalling 36 DABRA Laser devices because the footswitch may fail to protect against liquid ingress, potentially causing the laser to remain on.
Product
DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0623-2021·2020-12-23
Biomet OSS Polyethylene Tibial Bushing Recalled for Sterile Seal Breach
Biomet is recalling specific lots of OSS Polyethylene Tibial Bushings because a breach in the sterile seal could lead to loss of sterility.
Product
OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0613-2021·2020-12-23
Carl Zeiss Meditec VISULENS 550 Recalled for Electrical Shock Risk
Carl Zeiss Meditec is recalling VISULENS 550 refractive power measurement devices due to a defective communication board that may cause electrical shocks.
Product
Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0629-2021·2020-12-23
Biomet Recalls Sterile Trac System Thinflap Burr Hole Plates
Biomet is recalling specific lots of Sterile Trac System Thinflap 24 MM Burr Hole Plates because a breach in the sterile seal could lead to loss of sterility.
Product
Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0620-2021·2020-12-23
Biomet Shoulder System Surgical Handles Recalled for Sterile Seal Breach
Biomet is recalling specific lots of sterile shoulder system surgical instrument handles because a breach in the packaging seal could lead to loss of sterility.
Product
Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-limiting.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0621-2021·2020-12-23
Biomet Custom Cancellous Thread Recalled for Potential Sterile Seal Breach
Biomet is recalling specific lots of Custom Cancellous Thread devices because a breach in the sterile seal could lead to loss of sterility.
Product
Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0567-2021·2020-12-23
Mizuho Microsurgical Operating Room Tables Recalled for Unintended Movement
Mizuho America is recalling 10 microsurgical operating room tables due to unintended tilting and infrared signal errors that may cause incorrect operation.
Product
Microsurgical Operating Room Tables;7300BX (18-351-70).
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0566-2021·2020-12-23
Mizuho Microsurgical Operating Room Tables Recalled for Unintended Tilting
Mizuho America is recalling eight microsurgical operating room tables due to unintended tilting and infrared signal errors.
Product
Microsurgical Operating Room Tables;7300B (18-350-70);
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0633-2021·2020-12-23
Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breach
Maquet Cardiovascular is recalling the HLS Set Advanced because of breaches in the product's sterility barrier. The device is used with the CARDIOHELP system for cardiac and pulmonary support.
Product
HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0632-2021·2020-12-23
Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breaches
Maquet Cardiovascular is recalling HLS Set Advanced devices used for cardiac support due to breaches in the product's sterility barrier.
Product
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0617-2021·2020-12-23
Biomet Cannulated Screw System Recalled for Potential Sterile Seal Breach
Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile packaging seal could lead to loss of sterility.
Product
4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0628-2021·2020-12-23
Biomet Hip Prosthesis Recall for Potential Sterile Seal Breach
Biomet is recalling specific lots of RINGLOC BIPOLAR Hip System components due to a potential breach in the sterile seal, which could lead to loss of sterility.
Product
RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, Prosthesis, Hip…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0588-2021·2020-12-23
BD PrecisionGlide Needles Recalled Due to Blood Contamination
Becton Dickinson is recalling BD PrecisionGlide needles because blood was found on the cannulas, posing a potential infection risk if not noticed by clinicians.
Product
BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0636-2021·2020-12-23
Kowa VK-2s Software Recall for Potential Patient Data Deletion
Kowa Optimed Inc is recalling VK-2s software installed on nonmyd WX Retinal Cameras because a defect may cause the deletion of all patient information, potentially delaying treatment.
Product
Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0565-2021·2020-12-23
Terumo Capiox FX25 Advance Oxygenator Recall for Configuration Error
Terumo is recalling Capiox FX25 Advance Oxygenators because they may have the incorrect East or West configuration. The recall affects 5,079 units distributed in the US and abroad.
Product
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0634-2021·2020-12-23
Roche Recalls Tina-quant C-Reactive Protein Gen.3 Reagents Due to Cross-Contamination
Roche is recalling Tina-quant C-Reactive Protein Gen.3 reagents due to cross-contamination causing invalid calibrations and low quality control recovery.
Product
Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0637-2021·2020-12-23
Boston Scientific Recalls EKOS Control System Units Due to RF Board Failure
Boston Scientific is replacing 90 EKOS Control System 4.0 units in Latin America and the EU to prevent internal RF board failures at lower temperatures.
Product
EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0635-2021·2020-12-23
Helena Laboratories Recalls K-ACT Actalyke Clotting Test Tubes
Helena Laboratories is recalling K-ACT Actalyke Clotting Test Tubes due to complaints of cracked or split caps.
Product
K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0615-2021·2020-12-23
Medline Recalls RevMedX Trauma Dressings Due to Package Seal Integrity Issues
Medline Industries is recalling RevMedX Trauma Dressings because of package seal integrity issues. The recall affects 15,780 units distributed in the US and several international countries.
Product
RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Product Usage: are intended to absorb exudates.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0612-2021·2020-12-23
Medtronic Percept PC Neurostimulator Recall Due to Software Connection Failure
Medtronic is recalling 12 Percept PC Implantable Neurostimulators because a software anomaly in the A620 Patient Programmer prevents connection to the device.
Product
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0570-2021·2020-12-23
Zimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
Zimmer Biomet is updating instructions for Polaris and Cypher spinal screws to warn against using them with direct current stimulation due to construct failure risks.
Product
Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0568-2021·2020-12-23
Galt Medical Recalls Centeze Centesis Catheters Due to Tip Geometry Defect
Galt Medical Corporation is recalling 9,920 Centeze Centesis Catheters because a manufacturing issue resulted in incorrect tip geometry, specifically a thicker wall and more obtuse tip angle.
Product
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
Category
Medical Device
Distribution
9 states

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15776–15800 of 40287