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

13376–13400 of 27471

HighFDA (Devices)·Z-2541-2020·2020-07-15
Abbott Recalls TactiCath Quartz Contact Force Ablation Catheters Due to Data Loss
Abbott is recalling TactiCath Quartz Contact Force Ablation Catheters because they may lose contact force information during use.
Product
TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2527-2020·2020-07-15
TeDan Phantom CS Distraction Screw Recalled for Lack of Pouch Seal
TeDan Surgical Innovations is recalling 1,965 sterile Phantom CS Distraction Screws because the packaging lacks a pouch seal, compromising the sterile claim.
Product
PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2530-2020·2020-07-15
TeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect
TeDan Surgical Innovations LLC is recalling 340 sterile Phantom CS Quick Start Distraction Screws due to a lack of pouch seal.
Product
PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2524-2020·2020-07-15
TeDan 3COR Distraction Screw Recall Due to Sterility Seal Failure
TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws because the pouch seal is lacking, compromising the sterile labeling.
Product
3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2516-2020·2020-07-15
Kentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes
Kentec Medical is recalling 710 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying care or increasing radiation exposure.
Product
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube).
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2546-2020·2020-07-15
Cook Zenith Alpha Abdominal Endovascular Graft Recall for Damaged Bushing
Cook Inc. is recalling 571 units of Zenith Alpha Abdominal Endovascular Grafts due to a potential damaged bushing that may prevent full deployment.
Product
Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2495-2020·2020-07-15
Medtronic Perfusion Systems Recalls Extra Corporeal Circuits Due to Sterilization Failure
Medtronic Perfusion Systems is recalling 10 extra corporeal circuits with bio-active surfaces because they failed a sterilization test. The units were distributed only to California and Michigan.
Product
Extra corporeal circuit with bio-active surface.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2537-2020·2020-07-15
Vitalconnect VistaSolution Software Recall for Missing SpO2 Notifications
Vitalconnect Inc. is recalling VistaSolution software due to a defect that prevented low SpO2 alerts, potentially exposing patients to short-term hypoxia.
Product
VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring system in healthcare settings. This is a secondary, adjunct patient monitor and is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2490-2020·2020-07-15
Prodimed Combicath catheters recalled due to sterility assurance concerns
Prodimed is recalling 1,460 Combicath catheters nationwide because the company cannot assure the products are sterile.
Product
Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2517-2020·2020-07-15
Kentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes
Kentec Medical is recalling 2,130 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.
Product
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50 cm ENFit Enteral Feeding Tube).
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2526-2020·2020-07-15
TeDan Phantom CS Distraction Screw Recall for Lack of Pouch Seal
TeDan Surgical Innovations LLC is recalling 1,965 Phantom CS Distraction Screws because the packaging lacks a pouch seal, compromising the sterile labeling.
Product
PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2476-2020·2020-07-15
Verathon Recalls GlideScope Core OneTouch Smart Cables Due to Connection Defect
Verathon is recalling 437 GlideScope Core OneTouch Smart Cables because twisting during connection may damage the internal circuit board, causing video loss during critical intubation procedures.
Product
GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with the Core 10 and Core 15 monitors. The monitor and workstation are intended to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2500-2020·2020-07-15
XTANT Medical Recalls Irix-C Forceps Inserter Due to Fracture Risk
XTANT Medical is recalling four Irix-C Forceps Inserters because the strike plate may fracture off due to unsatisfactory welds.
Product
Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2521-2020·2020-07-15
United Imaging Recalls uDR 596i Digital Medical X-Ray Imaging Systems
Shanghai United Imaging Healthcare is recalling six uDR 596i digital medical X-ray systems due to software errors that may cause incorrect anatomical positioning or loss of image tags, leading to additional radiation exposure.
Product
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2514-2020·2020-07-15
Kentec Medical Recalls ENFit Feeding Tubes Due to Cap Fracture Risk
Kentec Medical is recalling 480 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.
Product
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-40P-50 (4 fr. 50 cm ENFit Enteral Feeding Tube).
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2488-2020·2020-07-15
Prodimed Combicath Catheters Recalled Due to Sterility Assurance Concerns
Prodimed Plastimed Division is recalling Combicath catheters for mini bronchoalveolar lavage because of a lack of assurance of sterility.
Product
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2494-2020·2020-07-15
Radiometer ABL800 FLEX Blood Gas Analyzer Software Recall
Radiometer Medical ApS is recalling ABL800 FLEX blood gas analyzers due to a software issue that may cause patient mix-ups.
Product
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all models and configurations.
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-2518-2020·2020-07-15
Kentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes
Kentec Medical is recalling ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying enteral feeding and medication administration.
Product
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube with Y-Port).
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2531-2020·2020-07-15
Philips M3015A Microstream CO2 Extension Recall for Incompatibility
Philips is recalling M3015A Microstream CO2 Extensions because they are incompatible with IntelliVue X3 and MMX monitors, which may cause a loss of monitoring.
Product
Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2542-2020·2020-07-15
KCI ACTIV.A.C Therapy System Recalled for Unexpected Power Off
KCI USA is recalling ACTIV.A.C Therapy Systems because they may power off without warning, stopping negative pressure wound therapy.
Product
ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2522-2020·2020-07-15
United Imaging uCT 760 CT System Recalled for Image Artifacts
Shanghai United Imaging Healthcare is recalling five uCT 760 CT systems due to intermittent image artifacts and scanning interruptions that may require patient rescans.
Product
uCT 760 System, Computed Tomography X-ray System
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2545-2020·2020-07-15
Centurion Difficult IV Kit Recalled for False Carboxyhemoglobin Results
Centurion Medical Products is recalling 140 Difficult IV Kits containing BD Vacutainer tubes that may cause false carboxyhemoglobin results.
Product
Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367960; Centurion code 45177 (VACUTAINER GREEN TOP) and 84815 (VACUTAINER 3ML LT. GREEN). Centurion Kit Code: IV8860
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2532-2020·2020-07-15
Bound Tree Medical Recalls Ambu King LTS-D Supraglottic Airway Kits
Bound Tree Medical is recalling 167 Ambu King LTS-D Supraglottic Airway Kits because they contain an incompatible catheter-tip syringe that may prevent the airway balloon from inflating properly.
Product
Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu¿ King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the components necessary to successfully obtain an open patient airway with an…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2493-2020·2020-07-15
Radiometer ABL800 FLEX Blood Gas Analyzers Recalled for Software Issues
Radiometer Medical ApS is recalling ABL800 FLEX blood gas analyzers due to a software issue that creates a potential risk of patient mix-up.
Product
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and…
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-2515-2020·2020-07-15
Kentec Medical Recalls ENFit Feeding Tubes Due to Cap Fracture Risk
Kentec Medical is recalling 2,850 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.
Product
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-50P-50 (5 fr. 50 cm ENFit Enteral Feeding Tube).
Category
Medical Device
Distribution
3 states

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13376–13400 of 27471