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

3051–3075 of 5038

SevereFDA (Devices)·Z-0626-2019·2018-12-26
FDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement
FDA is recalling specific lots of the Covidien Emprint Short Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft during use, potentially remaining in the patient.
Product
Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0589-2019·2018-12-19
Arjo Passive Clip Sling Recalled for Material Breakage Risk
ArjoHuntleigh is recalling 10 units of Passive Clip Slings because the material may break during patient transfers, posing a risk of falls and serious injury.
Product
ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted transfer of patient/resident with limited ability to move. Designed to be used for one patient during hospital stay and assists the caregiver wi
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0606-2019·2018-12-19
GE Healthcare Recalls Discovery NM/CT 670 DR Due to Electrical Hazard
GE Healthcare is recalling four Discovery NM/CT 670 DR units because incorrect wiring of safety switches may prevent the system from shutting off power, creating an electrical hazard.
Product
Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and c
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-0581-2019·2018-12-19
Leoni Fiber Optics Recalls Sterile Laser Fibers Due to Broken Seals
Leoni Fiber Optics is recalling sterile laser fiber assemblies distributed in Ohio because broken package seals may compromise sterility and increase infection risk.
Product
Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coa
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0463-2019·2018-12-12
GE Healthcare Recalls CARESCAPE R860 Inspiratory Safety Guards
GE Healthcare is recalling CARESCAPE R860 Inspiratory Safety Guards because they may disconnect from the breathing circuit, potentially causing loss of ventilation and hypoxia in patients.
Product
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0539-2019·2018-12-12
Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 3,764 units of Natural Nail System Tear Drop Guide Wires because creases in the packaging seal may compromise sterility.
Product
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2490-097-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0544-2019·2018-12-12
Philips Brilliance 40 CT Systems Recalled for Gantry Cover Separation Risk
Philips is recalling 6,343 Brilliance 40 CT systems nationwide due to a potential fiberglass resin separation that could cause the gantry front cover to fall.
Product
Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and displa
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0549-2019·2018-12-12
Invacare Hydraulic Patient Lifts Recalled for Potential Caster Separation
Invacare is recalling 73,703 hydraulic patient lifts because a mounting bolt may loosen, causing the caster to separate and the lift to tilt.
Product
Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lift and transfer a patient from one surface to another, as from a bed to a wheelchair. The device includes straps and a sling to support the pati
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0533-2019·2018-12-12
Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 2,080 units of ZMS Intramedullary Fixation Smooth Guide Wires because creases in the packaging may compromise sterility.
Product
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0536-2019·2018-12-12
Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 8,027 Humeral Guide Wires because creases in the sealing area may compromise product sterility.
Product
Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number: 47-2255-008-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0506-2019·2018-12-05
NxStage PureFlow B Solution Recalled Due to Bag Bursting Risk
NxStage Medical is recalling 7,275 units of PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.
Product
NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0505-2019·2018-12-05
NxStage PureFlow B Solution Recalled for Potential Bag Bursting
NxStage Medical is recalling PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.
Product
NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0470-2019·2018-12-05
Synaptive Medical Recalls BrightMatter Guide Software Due to Defect
Synaptive Medical Inc is recalling 37 units of BrightMatter Guide software due to a defect that occurs when switching between specific port trajectories during surgery.
Product
BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two co
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0437-2019·2018-12-05
Maquet Cardiovascular Recalls QUADROX-i Neonatal Membrane Oxygenators
Maquet Cardiovascular is recalling QUADROX-i Neonatal membrane oxygenators due to a potential for blood leakage at the blood inlet connector when using a specific reducing screw adapter.
Product
QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0507-2019·2018-12-05
NxStage PureFlow B Solution Recalled for Potential Bag Bursting Hazard
NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.
Product
NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0502-2019·2018-12-05
NxStage PureFlow B Solution Recalled for Potential Bag Bursting and Injury
NxStage Medical is recalling specific lots of PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.
Product
NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0514-2019·2018-12-05
Eurotrol HemoTrol Level 2 Recalled Due to Microbial Contamination
Eurotrol Inc. is recalling HemoTrol Level 2 hematology quality control mixtures because microbial contamination causes incorrect measurement results.
Product
HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0490-2019·2018-11-28
Smiths Medical Recalls Irrisept OR Bottle Assemblies Due to Sterility Risk
Smiths Medical is recalling 10,440 Irrisept OR bottle assemblies because leaking containers may compromise sterility, posing an infection risk.
Product
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Category
Medical Device
Distribution
37 states
SevereFDA (Devices)·Z-0474-2019·2018-11-28
Boston Scientific Recalls SQ-RX Pulse Generators for Battery Malfunctions
Boston Scientific is recalling 12,900 SQ-RX Pulse Generators used in S-ICD systems due to latent internal battery malfunctions that cause accelerated depletion.
Product
The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have sympto
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0488-2019·2018-11-28
Sedecal NOVA FA DR System Recalled for Potential Cable Failure
Sedecal S.A. is recalling 145 NOVA FA DR diagnostic radiography systems because installation or maintenance issues could cause support cables to break, leading to equipment falling.
Product
Sedecal NOVA FA DR System. for diagnostic radiography.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0478-2019·2018-11-28
Voluntis Recalls Insulia Diabetes Management Companion Due to Calculator Bug
Voluntis is recalling the Insulia Diabetes Management Companion because a bug in the Android basal calculator could cause hypoglycemia. An update is available to resolve the issue.
Product
Insulia Diabetes Management Companion
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-0448-2019·2018-11-21
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect
Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Product
Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0413-2019·2018-11-21
GE Healthcare Recalls Aisys Anesthesia System Touchscreen Display Kits
GE Healthcare is recalling 4,207 Aisys anesthesia system touchscreen display kits because they fail to transition to backup ventilation if a patient stops breathing.
Product
Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN DISPL
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0426-2019·2018-11-21
AROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Mesh Devices
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold mesh devices because the suture material degraded, causing them to fail burst specifications.
Product
OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-0417-2019·2018-11-21
AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 10x12cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.
Product
OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
Category
Medical Device
Distribution
8 states

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