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

22376–22400 of 27699

HighFDA (Devices)·Z-0622-2016·2016-01-20
OrthoPediatrics Recalls Response Spine Pedicle Screws Due to Manufacturing Defect
OrthoPediatrics Corp is recalling 102 Response Spine UniAxial Pedicle Screws because they may have been manufactured incorrectly, preventing the driver from fully engaging the screw.
Product
UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative…
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0648-2016·2016-01-20
Brainlab RT Elements software recall for image cropping defect
Brainlab AG is recalling RT Elements software because large objects may display cropped during import, potentially affecting radiation treatment planning.
Product
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0640-2016·2016-01-20
Ortho-Clinical VITROS 3600 Chemistry System Recalled for Software Anomaly
Ortho-Clinical Diagnostics is recalling VITROS 3600 Chemistry Systems due to a software anomaly that may allow the device to process assays at incorrect temperatures, potentially producing erroneous results.
Product
VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0626-2016·2016-01-20
Encore Medical Recalls AltiVate Reverse Humeral Broach Due to Undersized Feature
Encore Medical is recalling 23 AltiVate Reverse Humeral Broaches because the trial shell mating feature is undersized. The instruments are used with Encore Shoulder prostheses.
Product
AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0624-2016·2016-01-20
Nipro Medical Recalls Hemodialysis Blood Tubing Sets Due to Foaming
Nipro Medical Corporation is recalling 1,484 disposable hemodialysis blood tubing sets because blood foaming was found during product evaluation.
Product
NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0652-2016·2016-01-20
Intuitive Surgical Recalls da Vinci Xi 8mm Endoscopes for Safety Manual Correction
Intuitive Surgical is correcting the da Vinci Xi I&A User Manual to prevent unintended patient harm from capacitive coupling when using 8mm endoscopes with specific instruments.
Product
0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0653-2016·2016-01-20
Intuitive Surgical Recalls da Vinci Xi Endoscopes for Capacitive Coupling Risk
Intuitive Surgical is correcting the da Vinci Xi I&A User Manual to warn about unintended patient harm from capacitive coupling when using 8 mm endoscopes with specific instruments.
Product
30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0643-2016·2016-01-20
Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous results.
Product
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0627-2016·2016-01-20
Bayer Recalls Medrad Source Administration Sets for Dosing Errors
Bayer Healthcare is recalling Medrad Source Administration Sets because tubing defects may cause incorrect dose positioning during nuclear medicine procedures.
Product
Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0639-2016·2016-01-20
Mercury Medical Recalls Neo-Tee T-Piece Resuscitators Due to Occlusion Risk
Mercury Medical is recalling Neo-Tee T-Piece Resuscitators and circuits because incorrect use can cause complete circuit occlusion, leading to failure to ventilate the patient.
Product
Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0655-2016·2016-01-20
Skytron Ergon 2 Monitor Brackets Recalled Due to Hardware Failure Risk
Skytron is recalling 286 Ergon 2 monitor brackets because hardware may fail, causing displays to fall and potentially injure patients or providers.
Product
Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment…
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-0642-2016·2016-01-20
Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Software Anomaly
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may cause the device to process assays at incorrect temperatures, potentially producing erroneous results.
Product
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. Product Usage: The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0623-2016·2016-01-20
ArthroCare Cavity 8 Gauge Spine Wand Recalled for Sterile Barrier Failure
ArthroCare Corporation is recalling 262 Cavity 8 Gauge Spine Wands because cracking in the tray compromises the sterile barrier.
Product
Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0588-2016·2016-01-13
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter Recall for Handle Separation
Boston Scientific is recalling ACUITY Pro Coronary Sinus Guide Catheters due to a potential for the proximal handle to separate from the shaft.
Product
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0478-2016·2016-01-13
Stryker Fuhrman Pleural Drainage Set Recalled for Breakage During Insertion
Stryker is recalling 34 Fuhrman Pleural/Pneumopericardial Drainage Sets because they broke off in the pleural cavity during patient insertion.
Product
The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0592-2016·2016-01-13
Biomet 3i Protection Cap Kits Recalled for Inadequate Biocompatibility Testing
Biomet 3i is recalling 30,111 Protection Cap Kits worldwide due to inadequate biocompatibility testing. The devices are used as accessories for dental implants.
Product
BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET…
Category
Medical Device
Distribution
Distributed nationwide
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

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