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

38151–38175 of 40449

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
HighFDA (Devices)·Z-1565-2013·2013-07-03
Baxter MiniCap with Povidone-Iodine Solution Recalled for Leaking Pouches
Baxter Healthcare is recalling 629,280 units of MiniCap with Povidone-Iodine solution for dialysis due to leaking pouches. The recall is voluntary and nationwide.
Product
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1593-2013·2013-07-03
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, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1607-2013·2013-07-03
Medtronic Recalls Specific CRT-P Pacemakers for Potential Malfunction
Medtronic is recalling specific Consulta and Syncra CRT-P pacemakers manufactured in April and May 2013 due to a production issue that could cause malfunction. No device failures have been reported.
Product
Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-1602-2013·2013-07-03
Baxter Recalls Regional Analgesia Infusor Systems Due to Rupture Complaints
Baxter Healthcare is recalling Regional Analgesia Infusor Systems with Patient Control due to an increase in rupture complaints. The recall covers 3,255,096 units distributed nationwide and in Puerto Rico.
Product
Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1601-2013·2013-07-03
Baxter Recalls Multirate Infusor Devices Due to Rupture Complaints
Baxter Healthcare is recalling 3,255,096 Multirate Infusor Devices due to an increase in rupture complaints. The devices are indicated for the intravenous administration of medications.
Product
Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of medications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1578-2013·2013-07-03
Prism Medical C-Series Carry Bar Recalled for Improper Installation
Prism Medical Services USA is recalling 1,131 C-Series Carry Bars due to improper installation. The firm is replacing them with a plastic insert and metal insert carry bar.
Product
Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1605-2013·2013-07-03
Baxter Recalls SV Elastomeric Infusion Devices Due to Rupture Complaints
Baxter Healthcare is recalling SV Elastomeric Infusion Devices due to an increase in rupture complaints. The devices are used for intravenous medication administration.
Product
Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration of medications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1600-2013·2013-07-03
Baxter Recalls Infusor SV and LV Elastomeric Infusion Devices Due to Rupture Complaints
Baxter Healthcare is recalling Infusor SV and LV Elastomeric Infusion Devices due to an increase in rupture complaints. The recall aims to ensure no affected product remains in the field.
Product
Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1581-2013·2013-07-03
Roche Recalls CoaguChek XS Meters Due to Potential INR Test Errors
Roche is recalling CoaguChek XS meters because they may display an error message instead of a value, potentially leading to undetected elevated INR results.
Product
CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin¿ or warfarin.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1594-2013·2013-07-03
Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels
Medtronic is recalling 400 units of INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.
Product
INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1590-2013·2013-07-03
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, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1584-2013·2013-07-03
Roche Recalls CoaguChek XS Meters Due to Potential Test Errors
Roche is recalling CoaguChek XS System meters because they may display an error message instead of a value, potentially leading to undetected elevated INR results.
Product
CoaguChek XS System (HCP) The CoaguChek XS System is intended 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-1589-2013·2013-07-03
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, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1599-2013·2013-07-03
ConBio Recalls Multilite Dye Handpieces for Display Identification Inconsistency
ConBio is recalling 12 Multilite Dye Handpieces for the RevLite SI Laser due to an electronic display inconsistency that may confuse users.
Product
Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1610-2013·2013-07-03
Baxter Recalls Infusor Devices Due to Potential Leaks at Luer Connections
Baxter Healthcare is recalling specific Infusor devices because of increased complaints about leaks at the distal male Luer and Luer cap.
Product
Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day INFUSOR 2 ml/h System, Half Day INFUSOR SV 5 ml/h System, Two Day INFUSOR 2 ml/h System, Two day Infusor 2 ml/h, Multiday Infusor 0.5 ml/h, Multiday…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1587-2013·2013-07-03
U-systems Recalls Soma v Automated Breast Ultrasound System for Labeling Error
U-systems Inc is recalling three Soma v Automated Breast Ultrasound Systems because the user manuals incorrectly list the indication for use of a different product model.
Product
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1567-2013·2013-07-03
GE Healthcare Recalls CARESCAPE Monitor B850 for Software and Hardware Issues
GE Healthcare is recalling 12,779 CARESCAPE Monitor B850 units due to four potential issues, including uDOM failure, unstable USB communication, remote printing errors, and reboots caused by an X server freeze.
Product
CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1585-2013·2013-07-03
GE Healthcare Recalls Centricity Laboratory System Software Due to Data Loss
GE Healthcare is recalling 9 units of Centricity Laboratory System software versions 3.3, 4.0, and 4.1 because a specific configuration can cause loss of free-text data in microbiology results.
Product
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1564-2013·2013-07-03
Medtronic Launcher Guiding Catheter Recalled for Labeling Errors
Medtronic is recalling 24 units of Launcher Guiding Catheters because the packaging labels do not accurately reflect the catheters inside.
Product
Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1613-2013·2013-07-03
Beckman Coulter Recalls Lactate Reagent Due to Calibration Failures
Beckman Coulter is recalling 3,353 units of SYNCHRON Lactate Reagent because improper storage caused calibration failures, potentially delaying test results.
Product
SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s), UniCel¿ DxC 600/800 System(s) and Synchron¿ Systems Multi Calibrator, is intended for the quantitative determination of lactate…
Category
Medical Device
Distribution
Distributed nationwide

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38151–38175 of 40449