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 5038

SevereFDA (Devices)·Z-0443-2016·2015-12-23
Remel Recalls Gentamicin Antimicrobial Susceptibility Testing Discs
Remel Inc is recalling specific lots of Gentamicin Antimicrobial Susceptibility Testing Discs because the antibiotic concentration may be insufficient, potentially leading to incorrect test results.
Product
Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable a
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0374-2016·2015-12-16
Philips IntelliVue Information Center iX Software Recall for Alarm Failure
Philips is recalling IntelliVue Information Center iX software because SpO2 and NBP alarms may disable without visual notification.
Product
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, param
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0354-2016·2015-12-09
Philips Xper Vascular System Monitor Ceiling Suspension Recall
Philips Medical Systems is recalling 22 Allura Xper vascular systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0353-2016·2015-12-09
Philips Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling 14 Allura Xper Cardio systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0351-2016·2015-12-09
Philips Allura Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling 16 Allura Xper cardio systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and throm
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0349-2016·2015-12-09
Philips INTEGRIS Vascular System Recall for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling three INTEGRIS vascular systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0271-2016·2015-12-02
Alcon AcrySof IQ Toric IOL Recall Expanded for Post-Operative Inflammation
Alcon Research, Ltd. is expanding a recall of AcrySof IQ Toric intraocular lenses due to increased reports of post-operative inflammation in patients.
Product
Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0337-2016·2015-12-02
NxStage Hemodialysis System Recalled for Ultrafiltration Volume Software Error
NxStage Medical is recalling 7 units of the System One S Cycler hemodialysis system due to a software error that may cause the pump to continue removing fluid after the target volume is reached.
Product
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0274-2016·2015-11-25
Hill-Rom Recalls 100 Low Bed Units Due to Patient Injury Reports
Hill-Rom is voluntarily recalling 12,251 Hill-Rom 100 Low Beds because patients were injured while exiting the beds at the lowest position setting.
Product
Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0296-2016·2015-11-25
Fresenius Modified Mixer Motor Recalled Due to Fire Risk
Fresenius Medical Care is recalling 992 Modified Mixer Motors for 132 Gallon Dissolution Units because they lack full thermal protection, posing a fire hazard.
Product
Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0284-2016·2015-11-25
Prism Medical C-300 Ceiling Lifts Recalled for Drive Shaft Failure
FDA is recalling 561 Prism Medical C-300 ceiling lifts because the drive shaft and over-speed arm may fail simultaneously, potentially causing a patient to fall.
Product
Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg. Lifting aid used by health care professionals to lift, position, and transfer clients or disabled family members.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0230-2016·2015-11-25
Event Medical Recalls Inspiration Ventilators Due to Power Board Failure
Event Medical is recalling Inspiration Ventilator Systems because a power board component can fail, causing the device to shut down without an alarm.
Product
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0277-2016·2015-11-25
Teleflex Medical Recalls Taut Intraducers Due to Gas Leakage Risk
Teleflex Medical is recalling 2,050 Taut Intraducers 10/BX7.5 FR 3.5 devices because a defective component can cause gas leakage, potentially requiring device replacement.
Product
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0295-2016·2015-11-25
Fresenius 132 Gallon Dry Acid Dissolution Units Recalled for Fire Risk
Fresenius Medical Care is recalling 348 dry acid dissolution units because defective motors may generate smoke or cause fire.
Product
Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0294-2016·2015-11-25
Fresenius GranuFlo Dissolution Units Recalled for Fire Risk
Fresenius Medical Care is recalling 918 GranuFlo Dissolution Units because they lack full thermal protection, which can generate smoke or lead to fire.
Product
Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0285-2016·2015-11-25
Prism Medical P-300 Portable Consumer Lift Recalled for Drive Shaft Failure
ErgoSafe Products is recalling 1,721 Prism Medical P-300 Portable Consumer Lifts because the drive shaft and over speed arm may fail, potentially causing a patient to fall.
Product
Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0247-2016·2015-11-18
Maquet Adjustable Positioning Elements Recalled Due to Thromboembolic Events
Maquet is recalling Adjustable Positioning Elements used in spine surgery after two serious thromboembolic events were reported.
Product
Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0248-2016·2015-11-18
Maquet Universal Frame Recalled Due to Thromboembolic Event Reports
Maquet is recalling Universal Frames and Adjustable Positioning Elements after two serious thromboembolic events were reported during lumbar spine surgery.
Product
Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical
Category
Medical Device
Distribution
3 states
CriticalFDA (Devices)·Z-0151-2016·2015-11-11
Hamilton Medical Recalls HAMILTON-G5 Ventilators Due to Alarm Suppression Defect
Hamilton Medical is recalling 1,128 HAMILTON-G5 ventilators because suctioning maneuvers can unintentionally suppress ventilation and alarms.
Product
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0223-2016·2015-11-11
Bard Flair Endovascular Stent Graft Recalled for Deployment Failures
Bard Peripheral Vascular is recalling 292 units of the FLAIR Endovascular Stent Graft due to potential deployment failures during use.
Product
FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The F
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0188-2016·2015-11-04
FDA Recalls Pediatric Heart Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 57 pediatric heart surgical kits because compromised package integrity may affect sterility assurance.
Product
Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0169-2016·2015-11-04
Welch Allyn KleenSpec Corded Illuminator Recalled for Electric Shock Risk
Welch Allyn is recalling KleenSpec Corded Illuminators because they may be connected to AC power, posing a shock hazard.
Product
Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816, Rx ONLY
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0168-2016·2015-11-04
Siemens Medical Solutions Recalls 158 Radiation Therapy Machines
Siemens Medical Solutions is recalling 158 radiation therapy machines due to a potential safety risk of the gantry colliding with patients or treatment tables.
Product
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of cancer.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0191-2016·2015-11-04
Resource Optimization Recalls Custom Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 10 custom surgical kits distributed in Texas and Louisiana because compromised package integrity may affect sterility.
Product
Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0181-2016·2015-11-04
Elekta Monaco Radiation Treatment Planning Software Recalled for Dose Errors
Elekta is recalling Monaco Radiation Treatment Planning software due to unintended updates to dose and MU values and incorrect bolus assignments.
Product
Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Category
Medical Device
Distribution
6 states

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