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 deaths or serious injuries are reported, 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

3501–3525 of 5111

SevereFDA (Devices)·Z-0640-2018·2018-02-28
GastriSail Gastric Positioning Device Recalled Due to Perforation Reports
FDA is recalling 17,271 units of the GastriSail Gastric Positioning Device due to reports of gastric or esophageal perforation during surgical procedures.
Product
GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0642-2018·2018-02-28
Allen Medical Systems Recalls Radiolucent Surgery Spine Frames
Allen Medical Systems is recalling 161 Radiolucent Surgery Spine Frames because the base may crack during patient transfer.
Product
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0641-2018·2018-02-28
Allen Medical Bow Frame Recalled Due to Potential Base Cracking
Allen Medical Systems is recalling 161 Bow Frame Model A-70800 surgical platforms because the base may crack when patients are transferred onto the device.
Product
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0582-2018·2018-02-28
Medtronic Recalls Amplia MRI CRT-D Devices Due to Therapy Prevention Risk
Medtronic is recalling 951 Amplia MRI CRT-D devices because they may fail to deliver high or low voltage therapy.
Product
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d. Am
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0589-2018·2018-02-28
Medtronic Visia AF ICDs Recalled for Potential Therapy Failure
Medtronic is recalling 951 Visia AF ICDs and CRT-Ds because they may fail to deliver high or low voltage therapy.
Product
Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0586-2018·2018-02-28
Medtronic Recalls Claria MRI CRT-Ds Due to Therapy Prevention Risk
Medtronic is recalling 951 Claria MRI CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.
Product
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d. Claria
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0639-2018·2018-02-28
Zimmer Biomet Recalls ROSA Spine Stereotaxic Instrument Due to Positioning Error
Zimmer Biomet is recalling one ROSA Spine 1.0.2 Stereotaxic instrument because the robot arm may move to the wrong position during surgery.
Product
ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
Category
Medical Device
Distribution
11 states
SevereFDA (Drugs)·D-0376-2018·2018-02-21
Sage Q CARE Oral Cleansing System Recalled for Cross-Contamination
Sage Products Inc. is recalling Q CARE q2 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcohol-Free mouthwash, 4 Oropharyngeal
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0393-2018·2018-02-21
Sage Q.Care Oral System Recalled for Cross-Contamination Risk
Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Petit Size Suction Toothbrush packages with Antiseptic Oral Rinse, 4 Petit Size Untreated Suction Oral Swab packages with Antiseptic Oral Rinse, 2 8 French Oropha
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0375-2018·2018-02-21
Sage Q CARE Oral System Recalled for Cross-Contamination Risk
Sage Products is recalling Q CARE q4 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Thr
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0607-2018·2018-02-21
Sanofi Genzyme Recalls Synvisc-One Injections Due to Bacterial Contamination
Sanofi Genzyme is recalling Synvisc-One injections due to contamination with Methylbacterium thiocyanatum. The recall affects 12,380 units distributed in 36 states.
Product
Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Synvisc-One is administered as a single intra-articular injection. Synvisc-One is in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0397-2018·2018-02-21
Sage Products Recalls Q.Care Oral Cleansing Systems Due to Cross-Contamination
Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q.Care Oral Cleansing & Suctioning System q8. Contains 1 Covered Yankauer Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Antiseptic Solution,, 1 Suction Oral Swab packages with Perox-A-Mint solution, 1 Oropharyngeal Suction Catheter package. Sage Products, Inc
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0377-2018·2018-02-21
Sage Products Recalls Q CARE Oral Cleansing Systems Due to Cross-Contamination
Sage Products Inc. is recalling Q CARE q4 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0560-2018·2018-02-14
Recall of Emprint Percutaneous Antenna Due to Tip Disengagement
FDA is recalling Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
Product
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0559-2018·2018-02-14
Recall of Emprint Percutaneous Antenna Due to Tip Disengagement Risk
FDA is recalling Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
Product
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0557-2018·2018-02-14
Recall of Covidien Emprint Percutaneous Antenna Due to Tip Disengagement
FDA Class II recall of Covidien Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft and remain in the patient.
Product
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0558-2018·2018-02-14
Recall of Covidien Emprint Percutaneous Antenna Due to Tip Disengagement
FDA is recalling the Covidien Emprint Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
Product
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0554-2018·2018-02-14
Mindray TD60 Transmitter Battery Charger Recalled for Overcharging Risk
Mindray is recalling 203 TD60 Transmitter battery chargers used with the BeneVision Central Station because a damaged circuit board can cause the battery to overcharge and the case to swell.
Product
TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
Category
Medical Device
Distribution
27 states
SevereFDA (Devices)·Z-0556-2018·2018-02-14
Recall of Emprint Percutaneous Antenna Due to Tip Disengagement
FDA is recalling Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
Product
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0508-2018·2018-02-14
Siemens Artis Biplane Systems Recalled for Ceiling Mount Defect
Siemens is recalling 265 Artis zee and Artis Q biplane systems because ceiling mount screws may not be fastened correctly.
Product
AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0561-2018·2018-02-14
FDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement
FDA is recalling specific lots of the Covidien Emprint Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
Product
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0281-2018·2018-02-07
Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration
Medline is recalling 1,100 cases of GHS Suture Removal Trays because the iodine concentration is below the label claim.
Product
Medline GHS Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0307-2018·2018-02-07
Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration
Medline is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.
Product
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0317-2018·2018-02-07
Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration
Medline Industries is recalling 9,000 cases of Suture Removal Trays because the iodine concentration in the prep pads is below the labeled claim.
Product
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0299-2018·2018-02-07
Medline Recalls IV Start Kits With Subpotent Iodine Concentration
Medline Industries is recalling IV Start Kits because the iodine concentration in the prep pads is below the labeled claim.
Product
Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medical Equipment Affiliates., Tahlequah, OK 74464
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

3501–3525 of 5111