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

14676–14700 of 27471

HighFDA (Devices)·Z-0516-2020·2019-12-04
Beckman Coulter Recalls UniCel DxH Slidemaker Stainer Devices Due to Bent Probe Risk
Beckman Coulter is recalling UniCel DxH Slidemaker Stainer devices because a bent dispense probe may cause cell carryover, leading to erroneous lab results and potential inappropriate patient treatment.
Product
UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0575-2020·2019-12-04
Abbott Recalls Alinity c Carbon Dioxide Reagent Kits Due to CO2 Absorption
Abbott is recalling Alinity c Carbon Dioxide Reagent Kits because atmospheric carbon dioxide can be absorbed into the reagent, potentially causing incorrect test results.
Product
Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0535-2020·2019-12-04
FoundationOne CDx test reports recalled for potential false positive results
Foundation Medicine is recalling eight FoundationOne CDx test reports due to identified potential false positive MSI-H results.
Product
FoundationOne CDx test report
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0542-2020·2019-12-04
Endotronix Recalls myCordella Patient Kits for Unexpected Power-Downs
Endotronix is recalling 58 myCordella Patient Kits because the devices have been reported to power down without user interaction.
Product
myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tools to monitor the progression of heart failure.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0525-2020·2019-12-04
Zimmer Biomet Recalls Comprehensive RS Cleat CAP Due to Contamination
Zimmer Biomet is recalling Comprehensive RS Cleat CAP devices because elevated levels of bacterial endotoxin and residual debris remain on the products due to a cleaning issue.
Product
Comprehensive RS Cleat CAP, Item No. 110300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0527-2020·2019-12-04
Zimmer Biomet Recalls Copeland HA Resurfacing Heads Due to Cleaning Issues
Zimmer Biomet is recalling Copeland HA Resurfacing Heads because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Product
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0529-2020·2019-12-04
Zimmer Biomet Recalls Guide Wires Due to Bacterial Endotoxin and Debris
Zimmer Biomet is recalling specific Aim/Art Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
Product
GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0577-2020·2019-12-04
Boston Scientific Recalls Emerge Monorail PTCA Catheters Due to Coating Defect
Boston Scientific is recalling Emerge Monorail PTCA Dilatation Catheters because they may lack a required hydrophilic coating. The recall covers 14,145 devices distributed nationwide and in Canada.
Product
Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0518-2020·2019-12-04
Becton Dickinson Recalls Site~Rite 8 Ultrasound Systems Due to Battery Indicator Defect
Becton Dickinson is recalling 2,215 Site~Rite 8 Ultrasound Systems because the battery indicator may falsely show charge, causing abrupt shutdowns without warning.
Product
Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite¿ 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound System, Catalog No.9770501 Refurbished Site~Rite¿ 8…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0574-2020·2019-12-04
Abbott Recalls HAVAB-G Calibrator Due to Potential False Negative Results
Abbott is recalling 83 kits of ARCHITECT HAVAB-G Calibrator, lot 08219BE00, because increased RLU values may cause false non-reactive patient results.
Product
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-0532-2020·2019-12-04
Zimmer Biomet Recalls Total Elbow Replacement Devices Due to Cleaning Issues
Zimmer Biomet is recalling specific total elbow replacement devices because elevated levels of bacterial endotoxin and residual debris remain on them due to a cleaning issue.
Product
LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0420-2020·2019-11-27
Edwards Lifesciences Recalls EZ Glide Aortic Cannula Due to Connector Separation Risk
Edwards Lifesciences is recalling EZ Glide Aortic Cannulae because the cannula may separate from its connector, potentially causing significant blood loss during surgery.
Product
EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0498-2020·2019-11-27
Philips HeartStart XL+ Defibrillator Recall Due to Switch Failure
Philips is recalling HeartStart XL+ Defibrillators because a faulty switch may cause the device to fail or deliver incorrect shock energy.
Product
HeartStart XL+ Defibrillator/Monitor, Model 861290
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0510-2020·2019-11-27
Applied Medical Recalls GelPOINT Path Transanal Procedural Packs Due to Insulation Shift
Applied Medical Resources Corp is recalling GelPOINT Path Transanal Procedural Packs because the tip insulation on the electrosurgical probes may shift unintentionally.
Product
GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0489-2020·2019-11-27
Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise
Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0437-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 951 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are used in angiographic procedures.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0427-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Defect
Cook Inc. is recalling 791 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0484-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 100 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0491-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 230 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0415-2020·2019-11-27
Cook Inc. Recalls Guardia Access Nano Embryo Transfer Catheters
Cook Inc. is recalling 202 units of the Guardia Access Nano Embryo Transfer Catheter because bent tips may prevent insertion into the guiding catheter.
Product
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0425-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 165 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0450-2020·2019-11-27
Cook Torcon NB Advantage Catheters Recalled for Packaging Seal Defect
Cook Inc. is recalling 35 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are used in angiographic procedures.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0435-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 30 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0421-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0469-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Issues
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise product sterility.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide

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14676–14700 of 27471