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 the agency’s own highest classification or reported deaths or serious injuries, 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

26701–26725 of 27681

HighFDA (Devices)·Z-0901-2013·2013-03-13
GE Healthcare Recalls Advantage Workstation Volume Viewer Software
GE Healthcare is recalling Advantage Workstation Volume Viewer software due to potential safety issues that may result in incorrect views and measurements.
Product
GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast…
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0908-2013·2013-03-13
Medtronic DPL Single Stage Venous Cannula Recalled for Rough Metal Edges
Medtronic is recalling DPL Single Stage Venous Cannulas used in cardiopulmonary bypass due to potential rough metal edges on the tip side ports.
Product
Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0918-2013·2013-03-13
Ethicon PSX PROXIMATE Skin Staple Extractor Recalled for Sterility Concerns
Ethicon Endo-Surgery is recalling PSX PROXIMATE Skin Staple Extractors because packaging damage may have compromised the sterility of the devices.
Product
PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-0906-2013·2013-03-13
Philips CT System Software Recall for Incorrect Value Display
Philips is recalling 2,580 Extended Brilliance Workspace CT systems to fix a software defect that may display incorrect values.
Product
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer…
Category
Medical Device
Distribution
38 states
SevereFDA (Devices)·Z-0887-2013·2013-03-06
Aesculap Bipolar Generator Foot Pedal Recalled for Energy Failure
Aesculap, Inc. is recalling 59 Bipolar Generator Foot Pedals because the bipolar energy did not stop after the pedal was released.
Product
Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0896-2013·2013-03-06
Orthofix Firebird Spinal Fixation System Rod Connectors Recalled for Cracking Risk
Orthofix is recalling Firebird Spinal Fixation System rod connectors because a sub-component may crack during tightening.
Product
Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0894-2013·2013-03-06
Brio DBS implantable pulse generators recalled for unintended fluid ingress
Advanced Neuromodulation Systems Inc. is recalling Brio DBS System Model 6788 implantable pulse generators because unintended fluid ingress into the device header has been shown.
Product
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0897-2013·2013-03-06
Philips Ingenuity TF PET/CT System Recalled for Gating Trigger Risk
Philips Medical Systems is recalling one Ingenuity TF PET/CT unit in Ohio because the system may not default to the correct gating trigger, posing a risk to patients.
Product
Ingenuity TF PET/CT. Diagnostic imaging system
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0899-2013·2013-03-06
Philips MX 16-Slice CT Scanner Recall Due to Loose Table Screws
Philips Medical Systems is recalling 412 MX 16-Slice CT Scanner Systems because loose screws may cause the patient table top to detach.
Product
Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0878-2013·2013-03-06
Medacta Recalls Versafitcup Impacting Rings for Fit Issues
Medacta USA is recalling Versafitcup Impacting Rings because they may not fit properly in the implant shell, potentially causing surgical delays and complications.
Product
Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). Designed for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0885-2013·2013-03-06
Elekta Apex add-on Micro MLC collimator recall for installation defect
Elekta, Inc. is recalling Apex add-on Micro MLC collimators for radiation therapy because incorrect installation may cause the touchguard inhibit to activate and restrict the view restrictions dialog box.
Product
Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0893-2013·2013-03-06
Stryker XIA 3 Iliac Screwdriver Recalled Due to Unthreading Risk
Stryker Spine is recalling 46 units of the XIA 3 Iliac Screwdriver because the outer shafts may unthread during surgical use.
Product
Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0895-2013·2013-03-06
Orthofix ISKD Limb Lengthener Recalled for Potential Post-Operative Failure
Orthofix, Inc. is recalling ISKD limb lengtheners because the device may stop distracting after surgery, potentially causing premature bone consolidation and the need for revision surgery.
Product
Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0877-2013·2013-03-06
Intel-GE Care Innovations Recalls QuietCare Facility Servers for Software Defect
Intel-GE Care Innovations is recalling 19 QuietCare Facility Servers due to a software defect that may prevent Wander Alerts from being generated.
Product
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0880-2013·2013-03-06
Philips Brilliance CT Scanners Recalled for Software Data Flipping Error
Philips is recalling Brilliance CT scanners because a software anomaly causes Intensity Projection datasets to be flipped and incorrectly labeled left-to-right.
Product
Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-0889-2013·2013-03-06
Cellestis Recalls QuantiFERON TB Blood Collection Tubes Due to Contamination
Cellestis is recalling QuantiFERON-TB Gold blood collection tubes due to potential contamination. The recall affects 29,690 units distributed worldwide.
Product
Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0888-2013·2013-03-06
Cellestis Recalls QuantiFERON TB Blood Collection Tubes Due to Contamination
Cellestis is recalling QuantiFERON-TB Gold blood collection tubes due to potential contamination. The recall affects 309,400 units distributed worldwide.
Product
VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0883-2013·2013-03-06
Philips GEMINI TF Big Bore PET/CT Systems Recalled for Software Error
Philips is recalling 37 GEMINI TF Big Bore PET/CT systems because a software error may cause generated Intensity Projection data to be flipped and incorrectly labeled.
Product
Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed…
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-0875-2013·2013-03-06
KY TINGLING JELLY Personal Lubricant Recalled for Lack of FDA Clearance
McNeil-PPC Inc. is recalling KY TINGLING JELLY Personal Lubricant because the product is not cleared for marketing in the US.
Product
KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0831-2013·2013-02-27
DePuy LPS Diaphyseal Sleeves Recalled for Potential Fracture Risk
DePuy Orthopaedics is voluntarily recalling LPS Diaphyseal Sleeves due to a potential fracture risk at the taper junction during normal gait activities.
Product
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0846-2013·2013-02-27
Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0848-2013·2013-02-27
Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0830-2013·2013-02-27
DePuy LPS Diaphyseal Sleeves Recalled for Potential Taper Fracture
DePuy Orthopaedics is voluntarily recalling LPS Diaphyseal Sleeves because the taper connection may fracture under normal gait loads.
Product
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0843-2013·2013-02-27
Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling 19 NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0872-2013·2013-02-27
Hill-Rom Recalls Liko Overhead Rail Systems Due to Corrosion
Hill-Rom is recalling Liko Overhead Rail Systems because hardware corrosion in high-humidity areas caused two rail failures.
Product
Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems Product Usage - The Overhead Rail System allows overhead lifts to be mounted to the ceiling allowing versatility for use in lifting…
Category
Medical Device
Distribution
Distributed nationwide

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26701–26725 of 27681