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

4201–4225 of 5038

SevereFDA (Devices)·Z-1307-2015·2015-04-01
Philips Recalls Lithium Polymer Fiber Optic Module Batteries Due to Ignition Risk
Philips Medical Systems is recalling 79 lithium polymer fiber optic module batteries used in Intera MR Systems because a battery ignited during recharging.
Product
Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products: Wireless ECG Module used with the Precess MRI compatible Patient Monitoring S
Category
Medical Device
Distribution
20 states
SevereFDA (Devices)·Z-1282-2015·2015-03-25
Siemens LANTIS Oncology Servers Recalled for Potential Treatment Errors
Siemens is recalling 87 LANTIS Oncology Information System servers because using unvalidated operating systems may lead to incorrect patient treatment.
Product
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1288-2015·2015-03-25
Ossur LP Rotate Foot System Recalled for Insecure Assembly
Ossur H / F is recalling LP Rotate Foot System prosthetic devices because short threads on the shock module may cause it to detach, leading to falls.
Product
LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) with female pyramid adapte
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1251-2015·2015-03-18
Philips DuraDiagnost X-Ray System Recalled for Installation Defects
Philips Medical Systems is recalling 71 DuraDiagnost X-Ray systems worldwide due to improper installation risks that could cause equipment to fall or float.
Product
Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1247-2015·2015-03-18
Arjo Pressure IQ Evolve Mattress Recalled for Pressure Ulcer Risk
Arjo is recalling 1,034 Pressure IQ Evolve mattresses nationwide due to failures that resulted in pressure ulcers.
Product
Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1249-2015·2015-03-18
Microport Evolution Tibial Base Recalled for Casting Tool Defect
Microport Orthopedics is recalling 17 units of the Evolution Tibial Base knee prosthesis component due to a casting tool issue causing varying retaining wall thickness and keel offset.
Product
EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-1209-2015·2015-03-11
Boston Scientific Recalls IntellaTip MiFi Radiofrequency Ablation Catheters
Boston Scientific is recalling 14 IntellaTip MiFi radiofrequency ablation catheters due to reports of char formation on the distal tip electrodes.
Product
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Ir
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1240-2015·2015-03-11
Richard Wolf I-Cart Medical Video Equipment Recall for Overheating Transformers
Richard Wolf Medical Instruments Corp. is recalling 83 I-Cart units because transformers may overheat, causing smoke and black plastic material to leak from the chassis.
Product
The I-Cart is used to store, transport, and power video equipment used in medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1138-2015·2015-03-04
Invacare FDX Electric Wheelchairs Recalled for Fire Hazard
Invacare is recalling 60 FDX, TDX, and Storm Series power wheelchairs because wire damage can cause smoking, sparking, or fire.
Product
FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1137-2015·2015-03-04
Invacare TDX Electric Wheelchairs Recalled for Fire Hazard
Invacare is recalling 1,942 TDX, FDX, and Storm Series power wheelchairs because wire pinching can cause smoking, sparking, or fire.
Product
TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1075-2015·2015-03-04
Hospira Recalls Plum A+ Infusion Pumps Due to Alarm Failure
Hospira is recalling 190 Plum A+ infusion pumps because their alarm assemblies may fail to sound at any volume level.
Product
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or c
Category
Medical Device
Distribution
50 states
SevereFDA (Devices)·Z-1139-2015·2015-03-04
Invacare Electric Wheelchair Recall for Fire Hazard
Invacare is recalling 525 electric wheelchairs because a seating defect can pinch wires, potentially causing smoking, sparking, or fire.
Product
Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1035-2015·2015-02-25
GE Healthcare MRI Systems Recalled for Potential Ferrous Object Removal Delay
GE Healthcare is recalling MRI systems because a disconnected MRU could delay the removal of ferrous objects, posing a life-threatening injury risk.
Product
This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1128-2015·2015-02-25
Mako Surgical Recalls Restoris Partial Knee Application RIO Due to Burr Malfunction
Mako Surgical Corporation is recalling 228 units of the Restoris Partial Knee Application RIO because the surgical burr may continue spinning outside the intended boundary after controls are released.
Product
Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1126-2015·2015-02-25
CME America Recalls BodyGuard 323 Infusion Pumps for Over-Delivery Risk
CME America is recalling BodyGuard and BodyGuard 323 infusion pumps due to a potential for over-delivery of medication.
Product
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1051-2015·2015-02-18
Teleflex Recalls MAQUET SERVO Humidifiers Due to Cracked Flex Tubes
Teleflex Medical is recalling MAQUET SERVO Humidifier 163 units because cracks may occur in the corrugated flex tube, posing a risk to patients.
Product
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tu
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1089-2015·2015-02-18
Biomet Telluride Percutaneous Rod Inserter Long Recalled for Design Defect
Biomet Spine is recalling 10 units of the Telluride Percutaneous Rod Inserter Long because the device lacks a locking feature, posing a risk of rod disengagement during surgery.
Product
Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1090-2015·2015-02-18
Stryker Recalls MEDPOR Surgical Implants Due to Potential Intraoperative Damage
Stryker is recalling MEDPOR Surgical Implants because they may crack or break during surgery. The recall affects 1,051 units distributed worldwide.
Product
MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and r
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1091-2015·2015-02-18
Stryker Recalls MEDPOR BARRIER Sheets for Potential Deformation and Cracking
Stryker is recalling MEDPOR BARRIER Sheets due to risks of deformation, cracking, and loss of adhesion during surgery.
Product
MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and M
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1092-2015·2015-02-18
Stryker Recalls MEDPOR BARRIER Sheets Due to Deformation and Cracking Risks
Stryker is recalling MEDPOR BARRIER Sheets due to potential implant deformation, mechanical instability, and cracking during surgery.
Product
MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1008-2015·2015-02-18
Teleflex Recalls MAQUET Servo Humidifier 163 Due to Connector Cracks
Teleflex is recalling 18 MAQUET Servo Humidifier 163 units because connector mount cracks may cause leaks, potentially depriving patients of adequate anesthetic gases.
Product
MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the t
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1034-2015·2015-02-11
Animas Vibe Insulin Pump Recalled Due to Calibration Factor Overwrite
Animas Corporation is recalling 1,235 Vibe Insulin Infusion Pumps because calibration factors were overwritten, potentially causing the pump to fail to detect cartridges or alarms.
Product
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1054-2015·2015-02-11
Cardinal Health Recalls Lubricated Intubating Stylets Due to Shear Risk
Cardinal Health is recalling 104,432 Lubricated Intubating Stylets 6FR because a small piece of the sheath may shear off during removal, posing a risk to infants and pediatric patients.
Product
Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1059-2015·2015-02-11
Siemens LINAC Accelerators Recalled for Overheating and Smoke Emission
Siemens Medical Solutions is recalling 310 LINAC Accelerators because the internal electric board may overheat, causing thermal damage and smoke emission.
Product
LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1013-2015·2015-02-04
Siemens Syngo RT Therapist Software Recall Due to Mistreatment Risk
Siemens is recalling Syngo RT Therapist software because a combination with CTVision may cause wrong offset calculations, leading to patient mistreatment.
Product
Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
Category
Medical Device
Distribution
3 states

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4201–4225 of 5038