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

14026–14050 of 27471

HighFDA (Devices)·Z-1480-2020·2020-03-25
Aesculap Recalls Columbus Knee Implant Components Due to LDPE Particles
Aesculap Implant Systems LLC is recalling Columbus knee implant components because low-density polyethylene particles may be present on the surface when the packaging is opened.
Product
COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476K NN477K NN478K NN479K Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1519-2020·2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
Avid Medical is recalling 230 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1514-2020·2020-03-25
Siemens IMMULITE 2000 Estradiol Test Kits Recalled for High Discordant Results
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Estradiol test kits due to high discordant results that may lead to misinterpretation of patient menopausal status.
Product
IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1512-2020·2020-03-25
Boston Scientific DYNAGEN EL ICD DR Recall for Unapproved Software
Boston Scientific is recalling one DYNAGEN EL ICD DR device because a software update downloaded unapproved applications to four programmers.
Product
Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1495-2020·2020-03-25
Siemens Artis Q Angiography Systems Recalled for Software Movement Issue
Siemens is recalling Artis Q angiography systems because a software issue could block stand and table movements.
Product
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1523-2020·2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
Avid Medical is recalling 5,004 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1501-2020·2020-03-25
Siemens Ysio X-Ray System Recalled for Unexpected Tube Stand Movement
Siemens is recalling Ysio X-Ray systems because a software error may cause the ceiling tube stand to move unexpectedly when activated by the user.
Product
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1503-2020·2020-03-25
TeDan Surgical Recalls 3COR Distraction Screws Due to Packaging Damage
TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing an infection risk.
Product
D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1515-2020·2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
Avid Medical is recalling 21,326 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1481-2020·2020-03-25
Aesculap Recalls Knee Implant Components Due to Potential LDPE Particles
Aesculap Implant Systems LLC is recalling specific knee implant components because low-density polyethylene particles may be present on the surface upon opening.
Product
AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z NN473Z NN474Z NN475Z NN476Z NN477Z NN478Z NN479Z Product Usage…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1482-2020·2020-03-25
Aesculap Recalls Knee Implants Due to Potential LDPE Particles
Aesculap Implant Systems LLC is recalling specific knee implant components because low density polyethylene particles may be present on the surface.
Product
COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z NR074K NR074Z NR075K NR075Z NR076K NR076Z NR077K NR077Z NR078K NR078Z NR079K NR079Z Product…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1479-2020·2020-03-25
Aesculap Recalls Columbus Knee Implant Components Due to LDPE Particles
Aesculap Implant Systems LLC is recalling Columbus CR/PS Tibial Plateau knee implant components because low-density polyethylene particles may be present on the surface.
Product
COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K NN085K NN086K NN087K NN088K NN089K Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1520-2020·2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
Avid Medical, Inc. is recalling 1,001 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1504-2020·2020-03-25
TeDan 3COR Distraction Screws Recalled for Potential Sterility Compromise
TeDan Surgical Innovations is recalling 3COR Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing an infection risk.
Product
D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1525-2020·2020-03-25
Medtronic CareLink Encore Programmer Recalled for Cyber Vulnerabilities
Medtronic is recalling CareLink Encore 29901 programmers due to improper access control and cleartext transmission of sensitive information.
Product
Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1513-2020·2020-03-25
Siemens IMMULITE 1000 Estradiol Kits Recalled for Discordant Results
Siemens Healthcare Diagnostics is recalling IMMULITE 1000 Estradiol kits due to high discordant results that may lead to misinterpretation of patient menopausal status.
Product
IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1505-2020·2020-03-25
TeDan Surgical Innovations Recalls Quick Start Distraction Screws Due to Sterility Concerns
TeDan Surgical Innovations is recalling Quick Start Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing a risk of infection.
Product
DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1478-2020·2020-03-25
Aesculap Columbus Knee Implant Components Recalled for LDPE Particles
Aesculap is recalling Columbus R/PS Tibia Plateau knee implant components because low-density polyethylene particles may be present on the surface upon opening.
Product
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K NN077K NN078K NN079K Product Usage:Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1518-2020·2020-03-25
Avid Medical Recalls Custom Procedure Trays with Non-Sterile Gowns
Avid Medical is recalling 400 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1509-2020·2020-03-25
Stryker Strykeprobe Outer Sheath Replacement Recalled for Insulation Risk
Stryker is recalling Strykeprobe Outer Sheath Replacements because a length mismatch could cause the probe to melt, compromising insulation and allowing electricity to flow to the patient.
Product
Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This products was distributed with the following sheath/probe: 0250070451-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, Spatula-Tip…
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1442-2020·2020-03-18
CME BodyGuard Microset Infusion Sets Recalled for Fluid Under-Delivery
CME America is recalling BodyGuard Microset infusion sets because they may under-deliver fluids when used with specific infusion pump systems.
Product
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1476-2020·2020-03-18
Qiagen Rotor-Gene Q Software Recall for Incorrect Concentration Reporting
Qiagen is recalling Rotor-Gene Q instruments with software version 2.3.4 because a bug causes concentration results to be reported as logarithmic values, potentially leading to false negative test results.
Product
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1427-2020·2020-03-18
HeartWare HVAD System Battery Charger Recalled for Adapter Insertion Risk
Heartware, Inc. is recalling 5,489 HeartWare HVAD System Battery Chargers because users may mistakenly insert the AC adapter into the HVAD Controller power port.
Product
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT)…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1475-2020·2020-03-18
Getinge 88-Series Washer Disinfectors Recalled for Chamber Leakage Risk
Maquet Cardiovascular is recalling Getinge 88-Series washer disinfectors because ruptured spot welds may cause water leakage, posing slip and infection risks.
Product
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1455-2020·2020-03-18
Cardinal Health Recalls Non-Sterile Hypodermic Safety Needles
Cardinal Health is recalling Monoject Hypodermic Safety Needles that were shipped as non-sterile but labeled as sterile. The firm is not aware of any patient harm.
Product
Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
Category
Medical Device
Distribution
Distributed nationwide

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14026–14050 of 27471