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

4026–4050 of 5111

SevereFDA (Devices)·Z-1305-2016·2016-04-06
Siemens Recalls SOMATOM CT Systems Due to Cardio License Malfunction
Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction in cardio licenses that could hazard patients and personnel.
Product
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1309-2016·2016-04-06
ViewRay MRIdian Radiation Therapy System Software Recall
ViewRay is recalling 5 MRIdian Radiation Therapy Systems due to a software defect that may fail to prompt users to shift the couch to a new isocenter during re-optimization.
Product
MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1219-2016·2016-03-30
Castile Soap Towelettes Recalled Due to Bacterial Contamination
Covidien LLC is recalling Castile soap towelettes found in Foley trays and specimen kits because they are contaminated with bacteria.
Product
Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile soap towelettes are used to clean the genital area for male and female patients
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1220-2016·2016-03-30
Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits
The FDA is recalling specific lots of Aplicare Castile Soap towelettes found in medical kits due to bacterial contamination.
Product
Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1242-2016·2016-03-30
Siemens IMMULITE 1000 Estradiol Test Recalled for Faslodex Interference
Siemens Healthcare Diagnostics is recalling IMMULITE 1000 Estradiol Test kits because the drug Faslodex may cause falsely elevated results.
Product
IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of estradiol in serum, as an aid in th
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1181-2016·2016-03-23
Puritan Bennett 980 Ventilator Recalled for Touchscreen and Ventilation Issues
Medtronic is recalling 1,864 Puritan Bennett 980 ventilators worldwide due to unresponsive touchscreens and potential loss of primary ventilation.
Product
Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-1063-2016·2016-03-16
Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation
Arrow International is recalling Percutaneous Insertion Trays because the sheath body may separate from the hub, creating a potential for bleeding.
Product
Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1061-2016·2016-03-16
Arrow RediGuard IAB Recall Due to Sheath Separation Risk
Arrow International is recalling RediGuard IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.
Product
RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1058-2016·2016-03-16
Arrow Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding Risk
Arrow International is recalling Ultra 8 IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.
Product
Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1059-2016·2016-03-16
Arrow UltraFlex IAB Recall: Sheath Separation Risk
Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.
Product
UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases wor
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1062-2016·2016-03-16
Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation
Arrow International is recalling specific Percutaneous Insertion Trays because the sheath body may separate from the hub, posing a risk of bleeding.
Product
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases wor
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1081-2016·2016-03-16
Stryker Position Pro Mattress Recalled for Power Cord Fire Risk
Stryker is recalling Position Pro Mattresses because the power cord may melt, posing risks of electric shock and fire.
Product
Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated contro
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1027-2016·2016-03-09
NeoCoil 3.0T GEM Flex Coil Recalled for Potential Burn Risk
NeoCoil, LLC is recalling 2,121 units of the 3.0T GEM Flex Coil system due to a potential for higher than specified surface temperatures that may result in patient warming or burns.
Product
NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1024-2016·2016-03-09
Philips SENSE Body Coil 1.5T Recalled for Potential Patient Burns
Philips is recalling 5,672 SENSE Body Coil 1.5T units because improper cable placement can cause patient burns during MRI scans.
Product
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0799-2016·2016-03-02
Cook Inc. Recalls Single Lumen Central Venous Catheter Sets
Cook Inc. is recalling 1,341 single-lumen central venous catheter sets and trays due to a manufacturing defect that may cause catheter tip fracture or separation.
Product
Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0798-2016·2016-03-02
Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Splits
Cook Inc. is recalling 9,519 Shuttle Select Slip-Cath Catheters worldwide due to reports of catheter tip splits and separation, which can cause loss of function or complications.
Product
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular syst
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0866-2016·2016-03-02
GSI Group Recalls PRN 50-M+ Paper Chart Recorders for Fire Risk
GSI Group Inc. is recalling 2,257 PRN 50-M+ Paper Chart Recorders due to a risk of fire or electrical shock.
Product
PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. Thi
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0801-2016·2016-03-02
Cook Inc. Recalls Femoral Artery Pressure Monitoring Catheters Due to Tip Fracture Risk
Cook Inc. is recalling specific femoral artery pressure monitoring catheter sets and trays because a manufacturing defect may cause the catheter tip to fracture or separate.
Product
Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0800-2016·2016-03-02
Cook Inc. Recalls Single Lumen Pressure Monitoring Sets Due to Tip Fracture
Cook Inc. is recalling 2,280 single-lumen pressure monitoring sets and trays because a manufacturing defect may cause catheter tips to fracture or separate.
Product
Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0975-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number M00548430 (XMD P/N 70-0050-A14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The Endo
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0827-2016·2016-03-02
Draeger Medical Recalls Evita and Babylog Ventilators Due to Battery Defect
Draeger Medical is recalling Evita Infinity V500 and Babylog Infinity VN500 ventilators because the optional PS500 power supply unit batteries may discharge prematurely despite showing adequate charge.
Product
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0992-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 126 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-0050-C22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0981-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-0050-B12) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0921-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 326 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0935-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 189 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-0050-416) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Medical Device
Distribution
Distributed nationwide

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4026–4050 of 5111