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

4101–4125 of 5111

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-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-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-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-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-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-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-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
SevereFDA (Devices)·Z-0125-2016·2015-10-21
Synthes Recalls Titanium Elastic Nail Inserters Due to Mechanical Failure Risk
Synthes (USA) Products LLC is recalling 1,550 Inserter for Titanium Elastic Nails (TEN) devices due to a potential for mechanical failures such as breakage.
Product
Inserter for Titanium Elastic Nails (TEN), orthopedic device
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0052-2016·2015-10-14
Resource Optimization & Innovation Recalls Vaginal Hysterectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 36 vaginal hysterectomy surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO Custom procedure tray contains surgical instruments and accessories intended for use during a s
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0082-2016·2015-10-14
FDA Recalls Pacemaker Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 40 pacemaker surgical kits because equipment gloves may have splits or holes that compromise sterility.
Product
regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0059-2016·2015-10-14
FDA Recalls 726 Sterile Laparoscopic Cholecystectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 726 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical pr
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0068-2016·2015-10-14
Resource Optimization & Innovation LLC Recalls Pediatric Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 24 pediatric heart surgical kits due to potential sterility compromise from defective equipment gloves.
Product
regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgi
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0112-2016·2015-10-14
Elekta Monaco Radiation Treatment Planning System Software Recall
Elekta is recalling Monaco Radiation Treatment Planning System software version 5.10.00 because it may calculate incorrect dose and MU values under specific conditions.
Product
Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-0033-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 199 sterile open heart surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgic
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0078-2016·2015-10-14
FDA Recalls 24 Sterile Breast Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 24 sterile breast surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
Product
regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical proce
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0111-2016·2015-10-14
DePuy Orthopaedics Recalls Specialist 2 Intramedullary Rod Instruments Due to Fracture Complaints
DePuy Orthopaedics is voluntarily recalling select lots of the Specialist 2 Intramedullary Rod 400mm Instrument because the rod has fractured, leaving portions inside patients.
Product
Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C.¿ SIGMA¿ knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the
Category
Medical Device
Distribution
40 states
SevereFDA (Devices)·Z-0075-2016·2015-10-14
FDA Recalls 64 Sterile Peripheral Vascular Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 64 sterile surgical kits because equipment gloves may have splits or holes that compromise sterility.
Product
regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a s
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0070-2016·2015-10-14
FDA Recalls Robotic Hysterectomy Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 144 robotic hysterectomy surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800567, Sterile, GY0656 - Robotic Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0092-2016·2015-10-14
FDA Recalls 214 Sterile Neuro Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 214 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical
Category
Medical Device
Distribution
3 states

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4101–4125 of 5111