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

22351–22375 of 27663

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
SevereFDA (Devices)·Z-0557-2016·2016-01-06
Elekta Recalls MOSAIQ Oncology System Due to Dosage Calculation Error
Elekta, Inc. is recalling 399 units of the MOSAIQ Oncology Information System because a software issue with age and weight data can cause incorrect drug dosages.
Product
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0561-2016·2016-01-06
Beckman Coulter MicroScan Pos Breakpoint Combo Panel Recall
Beckman Coulter is recalling MicroScan Pos Breakpoint Combo Panel Type 20 due to falsely negative Voges-Proskauer results.
Product
MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0569-2016·2016-01-06
BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive
Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because they may contain insufficient EDTA additive, which can lead to erroneous platelet results.
Product
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0568-2016·2016-01-06
BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive
Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because some were manufactured with insufficient EDTA additive, which may lead to erroneous platelet results.
Product
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0566-2016·2016-01-06
Aesculap Valve XS Atrium Retractor Blades Recalled Due to Corrosion
Aesculap is recalling 41 Valve XS Atrium Retractor blades distributed in New York because corrosion was found on a ball joint caused by incorrect manufacturing materials.
Product
Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0570-2016·2016-01-06
BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive
Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because some were manufactured with insufficient EDTA additive, which may lead to erroneous platelet results.
Product
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Tan) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0559-2016·2016-01-06
Beckman Coulter MicroScan Pos Combo Panel Recall for False Negative Results
Beckman Coulter is recalling MicroScan Pos Combo panels that may produce falsely negative Voges-Proskauer results for Staphylococcus aureus.
Product
MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0563-2016·2016-01-06
Trumpf Ceiling Mounted Surgical Light Systems Recalled for Falling Hazard
Trumpf Medical Systems is recalling 20,713 ceiling-mounted surgical light systems because the spring arm can detach, causing the light head to fall.
Product
Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0567-2016·2016-01-06
BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive
Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA blood collection tubes because some were manufactured with insufficient EDTA additive, which may lead to erroneous platelet results.
Product
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA The Vacutainer Brand PLUS (Plastic) Tube with EDTA Vacutainer¿ Brand Serum Tube are evacuated blood collection tubes which…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0560-2016·2016-01-06
Beckman Coulter MicroScan Pos Combo Panels Recalled for False Negative Results
Beckman Coulter is recalling MicroScan Pos Combo and Breakpoint Combo panels due to falsely negative Voges-Proskauer results with Staphylococcus aureus.
Product
MicroScan Pos Combo Panel Type 34, Part No. B1017-214 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0558-2016·2016-01-06
Beckman Coulter MicroScan Pos Combo Panel Recall for False Negatives
Beckman Coulter is recalling MicroScan Pos Combo panels due to falsely negative Voges-Proskauer results with Staphylococcus aureus.
Product
MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0571-2016·2016-01-06
BD Vacutainer K2EDTA Tubes Recalled for Insufficient Additive
Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because some were manufactured with insufficient EDTA additive, which may lead to erroneous platelet results.
Product
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0442-2016·2015-12-30
Biomerieux Etest PIP/TAZO/CON-4 PTC 256 Recalled for Erroneous Results
Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC 256 antimicrobial susceptibility tests due to the potential for reporting false susceptible results for Piperacillin/Tazobactam.
Product
Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0448-2016·2015-12-30
Aesculap Flexible Orthopedic Instrument Tray Set Recalled for Breakage Risk
Aesculap, Inc. is recalling flexible orthopedic instrument tray sets because the shafts may break during surgery, potentially leaving fragments in patients.
Product
Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and…
Category
Medical Device
Distribution
Distributed nationwide

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22351–22375 of 27663