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

27001–27025 of 27722

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
SevereFDA (Devices)·Z-0467-2013·2012-12-12
iwalk BiOM Battery and Charger Recalled for Overheating and Smoke Risk
iwalk inc is recalling BiOM lower leg system batteries and chargers because they may overheat and smoke during charging.
Product
BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0447-2013·2012-12-12
Natus Olympic Cool-Cap Recalled Due to Frozen Screen Malfunction
Natus Medical is recalling 324 Olympic Cool-Cap systems because the control module screen may freeze, causing the device to stop cooling infants without visible alarm.
Product
The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0471-2013·2012-12-12
Biomet Recalls OSS Knee Reamer Sleeves Due to Sticking Risk
Biomet is recalling 46 OSS Knee Reamer Sleeves because the thin shaft reamer may get stuck and fail to slide into the sleeve.
Product
OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0457-2013·2012-12-12
Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect
Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.
Product
24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0462-2013·2012-12-12
Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect
Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip may detach and harm patients during surgery.
Product
24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0458-2013·2012-12-12
Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect
Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip could detach and harm patients during surgery.
Product
24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0464-2013·2012-12-12
Merit Medical Systems Recalls Custom Procedural Trays Due to Missing Tape
Merit Medical Systems is recalling 83 custom procedural trays because clear protective tape was not applied during manufacturing.
Product
Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0475-2013·2012-12-12
Philips Digital Diagnost Software Recall for Image Marker Error
Philips is recalling Digital Diagnost Software R2.0.2 because a mirrored image marker can be mistaken for a patient side indicator.
Product
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0472-2013·2012-12-12
Biomet Recalls OSS Knee Reamer Sleeves Due to Sticking Defect
Biomet is recalling 36 OSS Knee Reamer Sleeves because the thin shaft reamer may get stuck and fail to slide into the sleeve.
Product
OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0455-2013·2012-12-12
Stryker Neptune 2 Rover Recall Due to Binding Casters
Stryker is recalling 154 Neptune 2 Rover units because a castor design defect can cause binding, leading to operator strain and back pain.
Product
Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0474-2013·2012-12-12
Biomet Recalls Bio-Modular Humeral Heads Due to Missing Ion Implantation
Biomet, Inc. is recalling four Bio-Modular Humeral Heads because they are missing the ion implantation feature, which may cause increased wear and shorter implant life.
Product
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0452-2013·2012-12-12
Siemens IRON Flex Reagent Cartridges Recalled for Falsely Elevated Results
Siemens Healthcare Diagnostics is recalling IRON Flex reagent cartridges because environmental iron contamination can cause falsely elevated test results.
Product
Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of…
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-0466-2013·2012-12-12
Philips and Neusoft Recall CT Scanners Due to Detaching Patient Table
Philips and Neusoft are recalling 45 CT scanners because the patient table top can detach from the carrier, posing a risk of injury.
Product
NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0468-2013·2012-12-12
Invivo Expression MRI Patient Monitoring System Recalled for Detached Caster Risk
Invivo Corporation is recalling the Expression MRI Patient Monitoring System because a caster may detach during transport, causing the cart to fall.
Product
Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0453-2013·2012-12-12
OmniGuide BP-ROBOTIC Fiber Recalled Due to Glue Joint Failure
OmniGuide, Inc. is recalling 45 units of BP-ROBOTIC single-use fibers because a glue joint failure may cause the device to shift and fall into the patient.
Product
OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0459-2013·2012-12-12
Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect
Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.
Product
18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0461-2013·2012-12-12
Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect
Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip may detach and harm patients during surgery.
Product
24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0460-2013·2012-12-12
Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Plastic Flash
Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.
Product
18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-0456-2013·2012-12-12
Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect
Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.
Product
24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
27 states

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27001–27025 of 27722