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

26401–26425 of 27722

CriticalFDA (Devices)·Z-1570-2013·2013-07-03
Medtronic SynchroMed II Pump Recall for Unintended Drug Delivery
Medtronic is recalling SynchroMed II implantable infusion pumps due to a risk of unintended drug delivery during the priming bolus function, which may cause overdose or underdose symptoms.
Product
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1575-2013·2013-07-03
Medtronic Recalls INDURA 1P Intrathecal Catheters Due to Occlusion Risk
Medtronic is recalling INDURA 1P Intrathecal Catheters because the previous connector design has a greater potential for misalignment and occlusion.
Product
Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introducer needle, Sutureless pump connector with attached 7.6-cm catheter and Connector pin, Transparent Strain-relief sleeves, and anchors.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1580-2013·2013-07-03
Medtronic SynchroMed EL Pumps Recalled for Electrical Shorting Risk
Medtronic is recalling SynchroMed EL pumps due to potential internal electrical shorting that may cause therapy loss.
Product
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 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…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1576-2013·2013-07-03
Medtronic Recalls Sutureless Connector Intrathecal Catheters Due to Occlusion Risk
Medtronic is recalling 115,722 Sutureless Connector Intrathecal Catheters worldwide because the previous design has a greater potential for misalignment and occlusion.
Product
Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge introducer needle, Transparent Strain-relief sleeves, Opaque Strain-relief sleeves, and V-wing anchors. Contents of inner package…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1571-2013·2013-07-03
Medtronic SynchroMed EL Pumps Recalled for Unintended Drug Delivery
Medtronic is recalling SynchroMed EL implantable pumps due to a risk of unintended drug delivery during the priming bolus function, which may cause overdose or underdose.
Product
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1579-2013·2013-07-03
Medtronic SynchroMed II Pumps Recalled for Electrical Shorting Risk
Medtronic is recalling SynchroMed II pumps due to potential electrical shorting that may cause therapy loss or reduction.
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
0 states
SevereFDA (Devices)·Z-1574-2013·2013-07-03
Medtronic Recalls Intrathecal Catheter Pump Segment Revision Kits
Medtronic is recalling unused Model 8596SC Pump Segment Revision Kits due to a design flaw that increases the risk of catheter occlusion.
Product
Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connector, Spinal Segment Strain-relief sleeves, Pump segment strain-relief sleeves, Connector pin. Contents of inner package are STERILE. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1586-2013·2013-07-03
Medrad Recalls DC Power Cables for Veris MR Vital Signs Monitor
Medrad Inc is recalling 1,066 DC power cables for the Veris MR Vital Signs Monitor due to a design issue that could cause shorting and heating.
Product
DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1573-2013·2013-07-03
Medtronic Sutureless Pump Connector Revision Kit Recalled for Occlusion Risk
Medtronic is recalling Sutureless Pump Connector Revision Kits due to a design flaw that increases the risk of catheter occlusion.
Product
Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with Medtronic SynchroMed implantable drug infusion pumps. Contents of inner…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1597-2013·2013-07-03
RF Technologies Recalls Code Alert Advanced 4-Way Care Solution Due to Firmware Error
RF Technologies is recalling 167 Code Alert Advanced 4-Way Care Solution units because a firmware error may delay alarm transmission to the server.
Product
Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1608-2013·2013-07-03
Cordis RadialSource Spring Wire Transradial Access Kit Recalled for Undersized Tip
Cordis and Greatbatch Medical are recalling one lot of RadialSource Spring Wire Transradial Access Kits because some units have an undersized vessel dilator tip that cannot slide over the guidewire.
Product
Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1566-2013·2013-07-03
Loma Vista Medical Recalls TRUE Dilatation Balloon Valvuloplasty Catheters
Loma Vista Medical is recalling TRUE Dilatation Balloon Valvuloplasty Catheters because they deflate slower than the specified maximum of 10 seconds.
Product
TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1583-2013·2013-07-03
Roche Recalls CoaguChek XS Plus Systems Due to Potential Test Errors
Roche is recalling CoaguChek XS Plus systems because they may display an error message instead of a value, potentially leading to undetected elevated INR results.
Product
CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1582-2013·2013-07-03
Roche Recalls CoaguChek XS Pro Systems Due to Potential Test Errors
Roche is recalling 537 CoaguChek XS Pro Systems because they may display an error message instead of a prothrombin time value.
Product
CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1595-2013·2013-07-03
Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels
Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.
Product
INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1603-2013·2013-07-03
Baxter Recalls Intermate Infusion Pumps Due to Rupture Complaints
Baxter Healthcare is recalling Intermate Infusion Pumps due to an increase in rupture complaints. The recall covers 3,255,096 units distributed nationwide and in Puerto Rico.
Product
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1604-2013·2013-07-03
Baxter Recalls Intermate Infusion Pumps Due to Rupture Complaints
Baxter Healthcare is recalling Intermate Infusion Pumps due to an increase in rupture complaints. The company states that product and process improvements have since reduced the complaint rate.
Product
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1592-2013·2013-07-03
Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels
Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.
Product
INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1591-2013·2013-07-03
Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Concerns
Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.
Product
INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1606-2013·2013-07-03
Baxter Recalls Basal/Bolus Infusors Due to Rupture Complaints
Baxter Healthcare is recalling 3.2 million Basal/Bolus Infusors due to increased rupture complaints. The devices are used for intravenous medication administration.
Product
Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1609-2013·2013-07-03
Baxter Recalls Infusor SV Elastomeric Infusion Devices Due to Leak Complaints
Baxter Healthcare is recalling 601,230 Infusor SV Elastomeric Infusion Devices due to increased complaints of leaks at the distal male Luer and Luer cap.
Product
Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1569-2013·2013-07-03
Terumo Recalls Sarns TCM II Temperature Control Modules Due to Assembly Defect
Terumo is recalling seven Sarns TCM II Temperature Control Modules because internal testing found incorrectly assembled heatsinks that could cause unit failure.
Product
Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1572-2013·2013-07-03
Maquet Pediatric Arterial Cannula Recalled for Incorrectly Sized Connectors
Maquet is recalling specific pediatric arterial cannula packs because they may contain incorrectly sized connectors. The recall affects 100 units distributed in the US and internationally.
Product
MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1577-2013·2013-07-03
BD SafetyGlide Syringe Tray Recalled for Needle Mechanism Failure
Becton Dickinson is recalling 1,326,000 units of BD SafetyGlide Allergy syringe trays because the needle safety mechanism may disengage.
Product
BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1588-2013·2013-07-03
Philips CT Scanners Recalled for Patient Selection and Scan Safety Issues
Philips Medical Systems is recalling 50 CT scanners due to a software defect that can cause incorrect patient names to appear on exam pages and allow clinical scans to start during anti-virus scans.
Product
Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
Category
Medical Device
Distribution
Distributed nationwide

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26401–26425 of 27722