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

25401–25425 of 27686

HighFDA (Devices)·Z-0994-2014·2014-02-26
Integra CUSA Excel CEM Nosecone Recalled for Sticking Button
Integra LifeSciences is recalling CUSA Excel CEM nosecones because the blue COAG button may stick in the activated position.
Product
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0990-2014·2014-02-26
Perrigo Recalls Orbit Soft Infusion Sets Due to Connector Incompatibility
Perrigo Diabetes Care is recalling Orbit soft Infusion sets because the luer-lock connectors are incompatible with standard infusion pumps.
Product
Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0964-2014·2014-02-19
Stryker Accolade Broach Handle Recalled Due to Impaction Plate Fracture
Stryker Howmedica Osteonics Corp. is recalling 211 units of the Navigation Compatible Accolade Broach Handle because the impaction plate may dissociate or fracture from the main body.
Product
Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-0827-2014·2014-02-19
Tandem T:slim Insulin Pump Cartridges Recalled for Leak Risk
Tandem Diabetes Care is recalling specific lots of T:slim insulin cartridges due to a risk of leaking, which could cause incorrect insulin delivery.
Product
T:slim Insulin Delivery System Insulin Infusion Pump
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0969-2014·2014-02-19
Boston Scientific Recalls Coyote Balloon Dilation Catheters Due to Deflation Issues
Boston Scientific is recalling specific lots of Coyote balloon dilation catheters because the balloons may not deflate as expected during procedures.
Product
Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0971-2014·2014-02-19
Boston Scientific Recalls Coyote PTA Balloon Dilatation Catheters
Boston Scientific is recalling Coyote PTA Balloon Dilatation Catheters because the balloons may not deflate as expected during procedures.
Product
Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0967-2014·2014-02-19
Brainlab VectorVision Spine Instrument Star Unit ML Recall
Brainlab is recalling 25 VectorVision Spine Instrument Star Unit ML devices because pins may be made of incorrect material, posing a risk of corrosion and particle release during surgery.
Product
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0976-2014·2014-02-19
McKesson Recalls Horizon Medical Imaging PACS Software Due to Archive Errors
McKesson Information Solutions LLC is recalling 618 units of Horizon Medical Imaging PACS software because images may be archived to incorrect locations, causing display failures.
Product
Horizon Medical Imaging, Picture Archive Communication System (PACS).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0947-2014·2014-02-19
Ecolab Recalls Microtek Medical Bur Hole Latex Probe Covers
Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Latex Probe Covers because they did not undergo proper endotoxin testing.
Product
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0974-2014·2014-02-19
Custom Medical Specialties Recalls Ultrasound Probe Covers for Missing Endotoxin Testing
Custom Medical Specialties is recalling 2,610 sterile ultrasound probe covers because they were not tested for endotoxins to the required level.
Product
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0979-2014·2014-02-19
Philips Gemini TF Big Bore PET/CT Systems Recalled for Mechanical Binding
Philips is recalling 47 Gemini TF Big Bore PET/CT systems because the patient table can mechanically bind, causing an automatic emergency stop and incomplete scans.
Product
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-0948-2014·2014-02-19
Ecolab Recalls Vital Care Ultrasound Probe Covers Due to Testing Deficiencies
Ecolab Inc is recalling specific lots of Vital Care ultrasound probe covers because they did not undergo endotoxin testing to the proper levels.
Product
Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0946-2014·2014-02-19
Ecolab Recalls Microtek Medical Bur Hole Latex Probe Covers
Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Latex Probe Covers because they did not undergo endotoxin testing to the proper levels.
Product
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0945-2014·2014-02-19
Ecolab Recalls Microtek Medical Bur Hole Probe Covers for Endotoxin Testing
Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Probe Covers because they did not undergo proper endotoxin testing.
Product
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0938-2014·2014-02-19
Integra Recalls Malibu Polyaxial Screwdrivers Due to Potential Shaft Breakage
Integra LifeSciences is recalling 40 Malibu Polyaxial Screwdrivers because the shaft may break during use. No patient injuries have been reported.
Product
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical…
Category
Medical Device
Distribution
11 states
SevereFDA (Devices)·Z-0905-2014·2014-02-12
Medtronic Aquamantys3 Pump Generator Recalled for Electrical Safety Defect
Medtronic is recalling 242 Aquamantys3 Pump Generators because internal protection circuitry may fail, exposing patients to DC voltage during surgery.
Product
Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0908-2014·2014-02-12
Medtronic Mosaic Aortic Obturator Recalled for High Transvalvular Gradients
Medtronic is recalling Mosaic Aortic Obturators used with Mosaic Porcine Aortic Bioprostheses due to higher-than-expected transvalvular gradients after implant.
Product
Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0918-2014·2014-02-12
Edwards Lifesciences Recalls 26mm Transcatheter Heart Valve Crimpers
Edwards Lifesciences is recalling two lots of 26mm transcatheter heart valve crimpers because they may not open fully, potentially preventing proper valve preparation.
Product
Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0931-2014·2014-02-12
CareFusion Recalls Trifurcated Extension Sets Due to Potential Component Leak
CareFusion 303, Inc. is recalling Trifurcated Extension Sets (models ME 1224 and MP 9230) because a defect in the trifurcated component could result in a leak.
Product
Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0937-2014·2014-02-12
ITC-Nexus Dx Recalls Hemochron Jr. Citrate APTT Cuvettes for Inaccurate Results
ITC-Nexus Dx is recalling Hemochron Jr. Citrate APTT Cuvettes because they may produce higher than expected results in normal individuals.
Product
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0926-2014·2014-02-12
ArjoHuntleigh Rotoprone Therapy System Recalled for Lock Pin Malfunction
ArjoHuntleigh is recalling 231 Rotoprone Therapy Systems because a lock pin can become stuck, preventing patients from being positioned prone.
Product
The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0927-2014·2014-02-12
GE Healthcare Recalls CARESCAPE Monitor B850 Due to Communication Loss
GE Healthcare is recalling 12,945 CARESCAPE Monitor B850 units worldwide because the F5-01 Frame may lose communication with the patient monitor.
Product
CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0925-2014·2014-02-12
CareFusion Recalls SmartSite Needleless Connectors Due to Connection Issues
CareFusion is recalling SmartSite Needleless Connectors because they may unintentionally disconnect, be difficult to disconnect, or fail to disconnect from a female luer.
Product
SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0917-2014·2014-02-12
GE Healthcare Recalls Infant Resuscitation T-Piece Upgrade Kits
GE Healthcare is recalling 561 infant resuscitation T-piece upgrade kits because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture.
Product
Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0915-2014·2014-02-12
GE Healthcare Recalls Infant Resuscitation Units Due to Loose Adjustment Knob
GE Healthcare is recalling 48 Stand-Alone Resuscitation Units because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.
Product
Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infant.s
Category
Medical Device
Distribution
Distributed nationwide

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25401–25425 of 27686