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

39126–39150 of 40356

ModerateFDA (Devices)·Z-0572-2013·2012-12-26
Beckman Coulter Recalls Access hLH Calibrators Due to Stability Test Failures
Beckman Coulter is recalling Access hLH Calibrators because stability testing failed to verify expiration dating. The affected lots did not meet procedural requirements for shelf-life.
Product
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0564-2013·2012-12-26
BD Recalls Oral Dispensing Syringes Due to Mixed Tip Complaints
Becton Dickinson is recalling 2,786,000 units of 1 mL Oral Dispensing Syringes because a complaint reported mixed oral and non-oral syringe tips within the same lot.
Product
Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0569-2013·2012-12-26
DePuy Recalls Pinnacle Cancellous Screws Due to Labeling Error
DePuy Orthopaedics is recalling 118 Pinnacle Cancellous Screws because the labels incorrectly identify them as Cannulated Screws.
Product
Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard carton, labeled and shrink-wrapped. PINNACLE¿ CANCELLOUS Bone Screws are…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0607-2013·2012-12-26
Varian Segmented Cervix Applicator Set Recalled for Difficult Disconnection
Varian Medical Systems is recalling 15 units of the Segmented Cervix Applicator Set because the guide tube is difficult to disconnect from the cervical sleeve.
Product
Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0563-2013·2012-12-26
Dako CoverStainer Slide Rack Recalled for Performance Defects
Dako Denmark A/S is recalling CoverStainer Slide Racks because their expected lifetime does not meet performance requirements due to manufacturing variations.
Product
CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, during transfer through the staining process. The rack can hold up to 10 slides at a time, and is necessary for optimal CoverStainer…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0602-2013·2012-12-26
Bayer Recalls Medrad Continuum MR Infusion System Tubing Sets
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets due to a variation that may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0538-2013·2012-12-26
Zimmer Recalls Coonrad/Morrey Elbow Replacement Kits Due to Pin Error
Zimmer is recalling specific lots of Coonrad/Morrey elbow replacement kits because they may contain an incorrect small inner pin instead of the required regular pin.
Product
Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0527-2013·2012-12-26
Biomet Recalls EBI XFIX DFS Rail System Due to Missing Markings
Biomet is recalling 49 units of the EBI XFIX DFS Rail System because graduation markings were missing on 14 swivel clamps.
Product
EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0565-2013·2012-12-26
Del Mar Reynolds Medical Recalls BleaseFocus Anesthesia Workstations Due to Manual Error
Del Mar Reynolds Medical is recalling BleaseFocus Anesthesia Workstations and 700/900 Series Ventilators because the user manuals describe a secondary oxygen supply failure alarm that is not actually installed in the devices.
Product
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0526-2013·2012-12-26
EEG Info Recalls EEG NeuroAmp Devices Due to Mislabeling
EEG Info is recalling EEG NeuroAmp devices because of a potential risk associated with mislabeling.
Product
EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0596-2013·2012-12-26
Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Rate Issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0571-2013·2012-12-26
BioMotion SpineSix Medical Device Field Correction for Regulatory Deficiencies
BioMotion Medical Systems is issuing a field correction for SpineSix treatment tables to address regulatory deficiencies and prepare for premarket clearance.
Product
SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD touch screen that displays treatment time, positioning and magnitude and direction of motion. There are eight fully customizable…
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0535-2013·2012-12-26
Titan Spine Recalls Endoskeleton TA VBR Implants for Labeling Errors
Titan Spine is recalling 92 Endoskeleton TA VBR implants because their labels contain incorrect indications for use.
Product
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR Endoskeleton TA VBR is intended…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0598-2013·2012-12-26
Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Accuracy Issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0529-2013·2012-12-26
DePuy Mitek Sterile Reamers Recalled for Incorrect Size Labeling
DePuy Mitek is recalling 20 sterile reamers because 7 units were labeled as 11MM but contained 10MM reamers.
Product
DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0593-2013·2012-12-26
Bausch + Lomb Stellaris PC Vision Enhancement System Recall
Bausch & Lomb is recalling 124 Stellaris PC Vision Enhancement System modules because they may need recalibration.
Product
Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0558-2013·2012-12-26
Integra LifeSciences Recalls Mayfield Composite Series Base Units
Integra LifeSciences is recalling Mayfield Composite Series Base Units and Skull Clamps due to performance issues that could impact functionality.
Product
MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. The MAYFIELD Base Unit (A3101) is an operating room table accessory intended to be used to support a patient during diagnostic examination…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0604-2013·2012-12-26
Medrad Continuum MR Infusion System tubing sets recalled for flow accuracy issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0528-2013·2012-12-26
Mindray Recalls V Series Patient Monitors Due to Touchscreen Malfunction
Mindray is recalling V Series patient monitors because the touchscreens may stop responding to touch.
Product
Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0497-2013·2012-12-19
Medtronic SynchroMed II Pumps Recalled for Motor Stall Risk
Medtronic is recalling SynchroMed II pumps because unapproved drugs can cause motor stalls and stop drug delivery.
Product
Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0478-2013·2012-12-19
Verathon Recalls GlideScope Video Laryngoscopes Due to Blade Cracking
Verathon is recalling GlideScope GVL3, GVL4, and GVL5 video laryngoscopes because their reusable blades may crack.
Product
The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0496-2013·2012-12-19
Medtronic SynchroMed EL Pumps Recalled Due to Unapproved Drug Interactions
Medtronic is recalling SynchroMed EL implantable infusion pumps because using unapproved drugs can cause the pump to stop working, halting drug delivery.
Product
SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0499-2013·2012-12-19
Voluntary Recall of Specific Lots of Reusable TENS Electrodes
Covidien is voluntarily recalling specific lots of reusable TENS electrodes because manufacturing process exposure to an employee with a minor cut may have occurred.
Product
Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0495-2013·2012-12-19
Philips IntelliVue Information Center Recall for Audible Alarm Loss
Philips Healthcare is recalling IntelliVue Information Center software due to a potential loss of audible alarms caused by damaged internal audio cable contacts.
Product
Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0523-2013·2012-12-19
Becton Dickinson Recalls BD BBL Taxo XV Factor Strips Due to Manufacturing Defects
Becton Dickinson is recalling 650 vials of BD BBL Taxo XV Factor Strips because they were not manufactured to specifications and may cause false negatives or misidentification of Hemophilus species.
Product
BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***
Category
Medical Device
Distribution
Distributed nationwide

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39126–39150 of 40356