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

31276–31300 of 40449

HighFDA (Devices)·Z-0574-2016·2016-01-13
Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure
Corflex is recalling 1,406 post-operative knee braces because they may fail to maintain a locked position, potentially causing loss of balance or undesired knee movement.
Product
Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0578-2016·2016-01-13
Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure
Corflex is recalling 10 units of the Brielle Ortho Contender Post-Op-Knee Brace Lite because the brace may fail to maintain its locked position, potentially causing loss of balance or undesired knee movement.
Product
BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0596-2016·2016-01-13
Philips Lumify Diagnostic Ultrasound Recalled for Color Flow Display Error
Philips is recalling 21 Lumify Diagnostic Ultrasound units in the US because a software error displays Color Flow direction incorrectly, which could lead to misdiagnosis.
Product
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0577-2016·2016-01-13
Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure
Corflex is recalling 42 units of the Contender Post-Op-Knee Brace Lite because the brace may fail to maintain its locked position, potentially causing loss of balance or undesired knee movement.
Product
ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0605-2016·2016-01-13
Baxter Y-Type Spike Adapter Recalled for Potential Particulate Matter
Baxter Healthcare is recalling Y-Type Spike Adapters due to the potential presence of dark loose particulate matter on the spike.
Product
Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients vascular system through a vascular access device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0593-2016·2016-01-13
Biomet 3i Dental Impression Copings Recalled for Inadequate Biocompatibility Testing
Biomet 3i is recalling specific dental impression copings due to inadequate biocompatibility testing. The devices are distributed worldwide, including in the US.
Product
BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0572-2016·2016-01-13
Partners In Medicine Recalls CNSystems Task Force Monitor 3040i for Blood Pressure Errors
Partners In Medicine is recalling 28 CNSystems Task Force Monitor 3040i devices because they may provide incorrect blood pressure readings for some patients.
Product
CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0594-2016·2016-01-13
Biomet 3i Recall Dental Impression Coping Kits for Biocompatibility Testing
Biomet 3i is recalling 30,111 Provide Impression Coping Kits worldwide due to inadequate biocompatibility testing.
Product
BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0589-2016·2016-01-13
Maquet HCU 30 Heater-Cooler Unit Recalled for Power Supply Board Failure
Maquet is recalling HCU 30 Heater-Cooler Units due to a power supply board defect that can cause overheating and unit shutdown during cardiopulmonary bypass procedures.
Product
Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0580-2016·2016-01-13
Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure
Corflex is recalling 80 post-operative knee braces that may fail to maintain the locked position, potentially causing loss of balance or undesired knee movement.
Product
CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0601-2016·2016-01-13
3M Coban Self-Adherent Wrap Recalled for Latex Mislabeling
3M is recalling Coban Self-Adherent Wrap mislabeled as latex-free because it actually contains latex, posing a risk to users with latex sensitivity.
Product
3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0579-2016·2016-01-13
Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure
Corflex is recalling specific Post-Operative Knee Brace Lite models because they may fail to maintain the locked position, potentially causing loss of balance or undesired knee movement.
Product
ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0573-2016·2016-01-13
Smith & Nephew Recalls Mislabelled 35mm Patellar Knee Implant Components
Smith & Nephew is recalling 20 units of 35mm patellar knee implants incorrectly labeled as 32mm. The size mismatch prevents proper alignment of pegs during surgery.
Product
Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0604-2016·2016-01-13
Elekta Oncentra VMAT Radiation Therapy Planning System Recalled for Software Error
Elekta, Inc. is recalling 154 units of the Oncentra External Beam - VMAT radiation therapy planning system because a software error may cause the system to incorrectly include organs at risk as target volumes.
Product
Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0595-2016·2016-01-13
Benlan Pediatric Feeding Tubes Recalled for Incorrect Size Packaging
Benlan, Inc. is recalling specific lots of 8 FR pediatric feeding tubes that may be packaged with 5 or 6.5 FR tubes instead.
Product
MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0575-2016·2016-01-13
Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure
Corflex is recalling specific Post-Operative Knee Braces because they may fail to maintain a locked position, potentially causing loss of balance or unwanted knee movement.
Product
CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0576-2016·2016-01-13
Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure
Corflex is recalling specific models of the Hailey Ortho Contender Post-Op Knee Brace because they may fail to maintain a locked position, risking loss of balance or unwanted joint movement.
Product
HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0597-2016·2016-01-13
Siemens Syngo X-Workplace Software Recall for Incorrect Measurement Display
Siemens is recalling Syngo X-Workplace software version VD10E because it may display incorrect length measurements, potentially leading to the selection of medical devices of the wrong size.
Product
Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0603-2016·2016-01-13
Steris Amsco Warming Cabinet Recalled for Incorrect Temperature Labeling
Steris Corporation is recalling Amsco Warming Cabinets because the quick reference magnet displays incorrect Fahrenheit to Celsius conversions and default temperatures.
Product
AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0602-2016·2016-01-13
Ethicon Recalls Gynecare Thermachoice III Uterine Balloon Therapy System
Ethicon, Inc. is recalling the Gynecare Thermachoice III Uterine Balloon Therapy System because stability data does not support the labeled two-year shelf life.
Product
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0613-2016·2016-01-13
Siemens Acute Care CKMB TestPak Recalled for Barcode Scanning Issues
Siemens Healthcare Diagnostics is recalling 1,051 units of Acute Care CKMB TestPaks because barcode labels may not scan on Stratus CS systems.
Product
Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0612-2016·2016-01-13
Siemens Acute Care MYO TestPak Barcode Labels May Not Scan
Siemens Healthcare Diagnostics Inc is recalling 608 units of Acute Care MYO TestPaks because barcode labels may not scan on Stratus CS systems.
Product
Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0590-2016·2016-01-13
Zimmer NexGEN Tibial Components Recalled Due to Labeling Error
Zimmer Manufacturing B.V. is recalling specific NexGEN System tibial components because a carton was mislabeled, containing a different component than indicated.
Product
NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0611-2016·2016-01-13
Siemens Acute Care DDMR TestPak Barcode Scanning Recall
Siemens Healthcare Diagnostics is recalling Acute Care DDMR TestPaks because barcode labels may not scan on Stratus CS systems.
Product
Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0608-2016·2016-01-13
Otto Bock Recalls Modular Polycentric EBS Knee Joints Due to Service Error
Otto Bock is recalling 40 Modular Polycentric EBS Knee Joints serviced between April 2015 and November 2015 because the wrong Loctite was used during repair.
Product
Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
Category
Medical Device
Distribution
Distributed nationwide

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31276–31300 of 40449