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

25026–25050 of 40233

HighFDA (Devices)·Z-0531-2018·2018-02-14
Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators
Angiodynamics, Inc. is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering the desired microwave energy.
Product
Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN) H787900602US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0536-2018·2018-02-14
Bard Access Systems Recalls PowerPICC Provena Catheters Due to Possible Leaks
Bard Access Systems is recalling 53,699 PowerPICC Provena Catheters due to possible leaks at the luer hub extension leg junction.
Product
PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0523-2018·2018-02-14
Ecolab Recalls Disposable Light Handle Covers Due to Seal Gaps
Ecolab, Inc. is recalling Disposable Light Handle Covers because sterile packaging may contain gaps in the seal, potentially compromising sterility.
Product
Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated mailer box. Product Usage: Intended to be used as a…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0530-2018·2018-02-14
Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators
Angiodynamics is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering microwave energy.
Product
Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) H787900601US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0510-2018·2018-02-14
Philips BrightView X Gamma Cameras Recalled for Collimator Drop Risk
Philips Medical Systems is recalling BrightView X gamma cameras because collimators may drop to the floor during exchange, posing a physical hazard.
Product
BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0513-2018·2018-02-14
Philips Precedence 6 Imaging System Recalled for Collimator Drop Risk
Philips is recalling 1,387 Precedence 6 imaging systems because collimators may drop to the floor during exchange, posing a risk of injury.
Product
Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0534-2018·2018-02-14
Medtronic Recalls Vistec X-Ray Detectable Sponges Due to Blood Contamination
Medtronic is voluntarily recalling two lots of Vistec X-Ray Detectable Sponges due to possible contamination with human blood during manufacturing.
Product
Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0512-2018·2018-02-14
Philips BrightView Gamma Cameras Recalled for Collimator Drop Risk
Philips Medical Systems is recalling BrightView Model 882480 gamma cameras because collimators may drop to the floor during exchange, posing a physical hazard.
Product
BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0532-2018·2018-02-14
Spacelabs Telemetry Receiver Recall Due to Loss of Patient Monitoring
Spacelabs Healthcare is recalling 12 Xhibit Telemetry Receiver systems because they may drop off the central station, causing a loss of patient monitoring.
Product
Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0535-2018·2018-02-14
Medtronic Custom Perfusion Systems Recalled Due to Valve Flow Defect
Medtronic is recalling 2,914 custom perfusion systems because Terumo OPS valves may lack flow. The devices are used in cardiopulmonary bypass surgery.
Product
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0511-2018·2018-02-14
Philips BrightView XCT Gamma Camera Recalled for Collimator Drop Risk
Philips Medical Systems is recalling BrightView XCT gamma cameras because a collimator may drop to the floor during exchange, posing a risk of injury.
Product
BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0517-2018·2018-02-14
Panoramic PC-1000 Dental X-ray Units Recalled for Lift Motor Wear
Panoramic Rental Corp. is recalling PC-1000 dental X-ray units because the lift motor may wear if not properly maintained, posing a risk of injury.
Product
PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0507-2018·2018-02-14
Microline ReNew Reusable Grasper and Dissector Tips Recalled for Insulation Failure
Microline Surgical is recalling ReNew Reusable Grasper and Dissector Tips because heat-shrink insulation may split during sterilization, posing a burn risk during surgery.
Product
The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0527-2018·2018-02-14
Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators Due to Malfunction
Angiodynamics, Inc. is recalling 14,353 Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering microwave energy.
Product
Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0528-2018·2018-02-14
Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators
Angiodynamics, Inc. is recalling Accu2i pMTA Microwave Tissue Ablation Applicators that may fail to deliver energy due to coolant ingress.
Product
Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0509-2018·2018-02-14
Brainlab AIRO Mobile CT System Recalled for Unintended Motion Risk
Brainlab AG is recalling 102 AIRO Mobile CT Systems due to a risk of unintended motion while the system is in transport mode.
Product
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0516-2018·2018-02-14
Zimmer Biomet Recalls 1.0mm Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 1,524 non-sterile 1.0mm drill bits because a raw material anomaly may increase the risk of instrument fracture.
Product
DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-0514-2018·2018-02-14
Philips Precedence 16 Imaging System Recalled for Collimator Drop Risk
Philips is recalling 1,387 Precedence 16 imaging systems because collimators may drop to the floor during exchange, posing a physical hazard.
Product
Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0518-2018·2018-02-14
Philips Brilliance 64 CT System Recalled for Software Issues
Philips Medical Systems is recalling 1,801 Brilliance 64 CT systems due to software issues in version 4.1.6.
Product
Philips Brilliance 64 computed tomography x-ray system
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0525-2018·2018-02-14
ConvaTec Recalls Mislabelled Ostomy Skin Barrier Products
ConvaTec is recalling a portion of Lot 7H02242 SUR-FIT Natura Moldable Durahesive Skin Barrier units that were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier.
Product
SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector providing a protective barrier to patient skin.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0533-2018·2018-02-14
MedComp Recalls CT Port Kits Packaged With Incorrect Needle Size
Medical Components, Inc. is recalling 65 units of CT Port kits that were packaged with 21G needles instead of the labeled 18G needles.
Product
6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0548-2018·2018-02-14
Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Design Verification Gap
Zimmer Biomet is recalling 1,517 units of M/DN Intramedullary Fixation Humeral Guide Wires because the previous packaging configuration lacked design verification for 70cm lengths.
Product
M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0505-2018·2018-02-14
Cardiovascular Systems Recalls Peripheral Diamondback Atherectomy Systems Due to Labeling Error
Cardiovascular Systems Inc. is recalling eight units of the Peripheral Diamondback 1.25 Solid OAD system because labeling for two lots was potentially switched during production.
Product
Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-0555-2018·2018-02-14
Cyberonics Recalls Two VNS Therapy Programmer Units Distributed Before Approval
Cyberonics, Inc. is recalling two VNS Therapy Programmer units that were distributed in error before FDA approval of the specific software version.
Product
VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and…
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0522-2018·2018-02-14
Philips Ingenuity TF PET/CT Recalled for Missing Gantry Mounting Hardware
Philips is recalling two Ingenuity TF PET/CT systems because one wire channel inside the Gantry Separation Unit was missing mounting hardware.
Product
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Category
Medical Device
Distribution
0 states

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