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

39276–39300 of 40449

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
HighFDA (Devices)·Z-0473-2013·2012-12-12
Roche Recalls 78 Cobas 8000 Analyzers Due to Reagent Pipetting Defect
Roche Diagnostics is recalling 78 Cobas 8000 Modular Analyzers because a probe positioning mismatch can cause insufficient reagent pipetting, potentially affecting test results.
Product
Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0463-2013·2012-12-12
Sekisui Spectrolyse PAI-1 Assay Recalled for Lower Absorbance Values
Sekisui Diagnostics is recalling Spectrolyse PAI-1 kits because they produce lower than expected absorbance values, which reduces the standard curve slope.
Product
Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0465-2013·2012-12-12
Siemens syngo.plaza Radiological Image Processing System Software Update Recall
Siemens Medical Solutions USA, Inc. is recalling 15 syngo.plaza systems to address unintended software behavior that may affect system performance.
Product
Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0469-2013·2012-12-12
Stryker Orthopaedics Recalls Mismarked Femoral Offset Bushing Instruments
Stryker Howmedica Osteonics Corp. is recalling 7 units of non-sterile Femoral Offset Bushing Triathlon Revision Instruments due to incorrect or missing rotational markings.
Product
Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0454-2013·2012-12-12
Stryker Neptune 2 Rover Recall Due to Castor Binding Defect
Stryker is recalling Neptune 2 Rover waste management systems because a castor design defect can cause the unit to bind, potentially leading to operator back pain.
Product
Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, 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
ModerateFDA (Devices)·Z-0480-2013·2012-12-12
Siemens Mobilette Mira Mobile X-ray System Recalled for Image Loss Risk
Siemens Medical Solutions USA is recalling 21 Mobilette Mira mobile x-ray systems due to a risk of lost images during examination.
Product
Siemens Mobilette Mira, intended use as Mobile x-ray system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0470-2013·2012-12-12
Stryker Tibial Offset Bushing Recall Due to Incorrect Markings
Stryker Howmedica Osteonics is recalling 8 Tibial Offset Bushings because rotational reference numbers were marked incorrectly or missing.
Product
Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green…
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0161-2013·2012-12-05
Medpro Elastomeric Infusion Pump Recalled for Higher Flow Rate
First Medical Source LLC is recalling 500 units of Medpro Elastomeric Infusion Pumps because they may deliver medication at a higher flow rate than specified, risking over-administration.
Product
Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0435-2013·2012-12-05
Terumo Advanced Perfusion System 1 Recalled for Total Loss of Functionality
Terumo is recalling 1,647 Advanced Perfusion System 1 units because they may shut down completely, stopping pumps and failing to activate battery backup.
Product
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0436-2013·2012-12-05
Terumo Advanced Perfusion System 1 Recalled for Power Loss
Terumo is recalling Advanced Perfusion System 1 units that may lose power and shut down during use, causing pumps to stop.
Product
220/240V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0439-2013·2012-12-05
Cooper Surgical RUMI Arch Uterine Manipulator Handle Recalled for Steel Rod Protrusion
Cooper Surgical is recalling RUMI Arch handles because excessive pressure may cause an internal steel rod to protrude through the shaft.
Product
Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0438-2013·2012-12-05
Extremity Medical Recalls IO FiX X-Post Reamer Due to Intraoperative Breakage
Extremity Medical LLC is recalling 156 units of the IO FiX X-Post Reamer after reports of the device breaking during surgery.
Product
IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-0441-2013·2012-12-05
Medtronic Recalls Vertex Max Drill Tubes Due to Threading Defect
Medtronic is recalling 12 Vertex Max Drill Tubes due to a defect in the internal threading used for component setup.
Product
The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0443-2013·2012-12-05
Parks Medical Electronics Recalls Vascular Blood Flow Machines Due to Connection Error
Parks Medical Electronics is recalling 349 vascular blood flow machines after two incidents where an air supply tube was connected to a patient's IV instead of a blood pressure cuff.
Product
Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0440-2013·2012-12-05
Cooper Surgical Recalls Advincula Arch Uterine Manipulator Handles
Cooper Surgical is recalling Advincula Arch handles because the internal steel rod may protrude through the shaft, posing a risk of injury during surgery.
Product
Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0437-2013·2012-12-05
Zimmer Recalls NexGen Knee Components Due to Manufacturing Cleaning Defects
Zimmer is recalling specific lots of NexGen knee components because they were processed outside validated cleaning parameters, potentially leaving residual particulate.
Product
NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen¿¿ system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic…
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-0450-2013·2012-12-05
GE Healthcare Recalls Mobile X-Ray Units Due to Software Issue
GE Healthcare is recalling Optima XR200amx and XR22Oamx mobile X-ray units due to a software issue on the interface.
Product
GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0442-2013·2012-12-05
Biomet Echo Hip Stems Recalled Due to Incorrect Size Etching
Biomet, Inc. is recalling four Echo Bi-Metric hip stems because the etching on the 11mm stems incorrectly indicated they were 13mm stems.
Product
Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0449-2013·2012-12-05
GE Healthcare Recalls Mobile X-Ray Systems Due to Software Issue
GE Healthcare is recalling Optima XR220amx and XR200amx mobile X-ray systems due to a software issue on the interface.
Product
GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE…
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

39276–39300 of 40449