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

33476–33500 of 40449

HighFDA (Devices)·Z-1237-2015·2015-03-11
Elekta Monaco Radiation Therapy System Recalled for Incorrect CT to ED Conversion
Elekta, Inc. is recalling Monaco radiation therapy treatment planning systems because the Image Statistics Tool may incorrectly convert CT to ED values.
Product
Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1222-2015·2015-03-11
Halyard Health Recalls KimVent Wet Pak Closed Suction Systems
Halyard Health is recalling KimVent Wet Pak closed suction systems because a defect may cause air leaks.
Product
KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-1244-2015·2015-03-11
Elekta Focal Sim radiation therapy system recalled for image statistics error
Elekta, Inc. is recalling 907 Focal Sim radiation therapy treatment planning systems because the Monaco Image Statistics Tool may produce incorrect CT to ED values.
Product
Focal Sim radiation therapy treatment planning system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1230-2015·2015-03-11
Siemens ADVIA Centaur Progesterone Kit Recalled for High Bias in Results
Siemens is recalling ADVIA Centaur Systems Progesterone Kits because results above 30 ng/mL show high bias. The recall covers 11,980 kits distributed worldwide.
Product
ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1210-2015·2015-03-11
Xoran MiniCAT X-ray devices recalled for imaging and dose defects
Xoran Technologies is recalling 432 MiniCAT X-ray imaging devices nationwide due to out-of-tolerance kVp, unexposed frames, and out-of-tolerance dose.
Product
Xoran MiniCAT X-ray imaging device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1223-2015·2015-03-11
Ikaria INOmax DSIR Nitric Oxide Delivery System Recalled for Alarm Defect
INO Therapeutics is recalling 45 INOmax DSIR units because a specific software and display combination may trigger false alarms, interrupting nitric oxide therapy.
Product
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1216-2015·2015-03-11
Arjo RotoRest Delta Therapy System Recalled for Unapproved Medical Claims
Arjo Hospital Equipment AB is recalling 271 RotoRest Delta Advanced Therapy Systems because their labeling contains unapproved medical claims.
Product
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1218-2015·2015-03-11
Arjo TriaDyne Proventa Critical Care Therapy System Recalled for Unapproved Claims
Arjo Hospital Equipment AB is recalling 567 TriaDyne Proventa Critical Care Therapy Systems because their labeling and instructions for use contain unapproved medical claims.
Product
TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1246-2015·2015-03-11
DePuy Orthopaedics Recalls Partially Agglomerated SMARTSET GHV Bone Cement
DePuy Orthopaedics is recalling one lot of SMARTSET GHV Gentamicin Bone Cement because it is partially agglomerated, which may cause surgical delays.
Product
SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1227-2015·2015-03-11
Baxter Recalls Syringe Tip Caps for Missing Latex Symbol
Baxter is recalling Self-Righting Syringe Tip Caps because the latex symbol is missing from the labels.
Product
Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1241-2015·2015-03-11
Stryker Recalls V40 Femoral Heads Due to Assembly Issues
Stryker Howmedica Osteonics is recalling nine V40 femoral heads because they could not be assembled with their corresponding stem trunnions.
Product
LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1217-2015·2015-03-11
Arjo Rotoprone Therapy System Recalled for Unapproved Medical Claims
Arjo Hospital Equipment AB is recalling 226 Rotoprone Therapy Systems because their labeling and instructions for use contain unapproved medical claims.
Product
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1231-2015·2015-03-11
Siemens ADVIA Centaur Progesterone Kit Recalled for High Result Bias
Siemens is recalling ADVIA Centaur Progesterone Kits due to high bias in results above 30 ng/mL. The recall affects 1,719 kits distributed worldwide.
Product
ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1229-2015·2015-03-11
Siemens ADVIA Centaur Progesterone Kit Recall for High Bias in Results
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems Progesterone Kits because results above 30 ng/mL may show high bias.
Product
ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1245-2015·2015-03-11
Baxter AMIA v1.0 APD System Recall for Labeling Warning
Baxter Healthcare is recalling 55 AMIA v1.0 APD Systems to add a warning about the risk of unintended increased intraperitoneal volume for vulnerable patients.
Product
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1226-2015·2015-03-11
Intuitive Surgical Recalls Vacuum Source Tubing Sets for Sterility Concerns
Intuitive Surgical is recalling 706 Vacuum Source Tubing Sets for the EndoWrist Stabilizer because shipping damage may have compromised the sterile packaging.
Product
Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1232-2015·2015-03-11
Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to False Negatives
Remel Inc is recalling Oxoid Legionella BCYE Growth Supplement SR0110A because it may fail to recover Legionella pneumophila, leading to false negative test results.
Product
Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1219-2015·2015-03-11
Zimmer Segmental System Hip Stem Recalled for Coating Defect
Zimmer, Inc. is recalling specific Zimmer Segmental System hip stems because the PMMA coating may be missing or not meet specifications.
Product
Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1239-2015·2015-03-11
CooperSurgical Pessary Kit Recalled for Incorrect Size Labeling
CooperSurgical is recalling 95 units of Pessary Kit-CUBE#2 because the packaging label displays the incorrect size.
Product
CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1233-2015·2015-03-11
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Recalled for Labeling Error
Arrow International Inc. is recalling 165 units of FiberOptix Intra-Aortic Balloon Catheter Kits because the outer package label incorrectly identifies the product size.
Product
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1228-2015·2015-03-11
Medtronic CareLink Pro Software Recall for Inaccurate Basal Data Display
Medtronic MiniMed is recalling CareLink Pro and CareLink Clinical software due to a defect that may cause inaccurate display of Temp Basal time and duration in reports.
Product
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1137-2015·2015-03-04
Invacare TDX Electric Wheelchairs Recalled for Fire Hazard
Invacare is recalling 1,942 TDX, FDX, and Storm Series power wheelchairs because wire pinching can cause smoking, sparking, or fire.
Product
TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1075-2015·2015-03-04
Hospira Recalls Plum A+ Infusion Pumps Due to Alarm Failure
Hospira is recalling 190 Plum A+ infusion pumps because their alarm assemblies may fail to sound at any volume level.
Product
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or…
Category
Medical Device
Distribution
50 states
SevereFDA (Devices)·Z-1131-2015·2015-03-04
HeartWare Controller Recall Due to Higher Susceptibility to Electrostatic Discharge
HeartWare Inc is recalling 4,845 HeartWare Controllers used in ventricular assist systems because they are more susceptible to electrostatic discharge (ESD) than newer models.
Product
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1138-2015·2015-03-04
Invacare FDX Electric Wheelchairs Recalled for Fire Hazard
Invacare is recalling 60 FDX, TDX, and Storm Series power wheelchairs because wire damage can cause smoking, sparking, or fire.
Product
FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
Category
Medical Device
Distribution
Distributed nationwide

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33476–33500 of 40449