Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

43326–43350 of 50511

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 (Drugs)·D-619-2013·2013-07-03
Hospira Recalls Sodium Chloride Injection Due to Sterility Concerns
Hospira is voluntarily recalling specific lots of 0.9% Sodium Chloride Injection due to possible leaking bags that may compromise sterility.
Product
0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1565-2013·2013-07-03
Sara Lee Sesame Seed Hamburger Buns Recalled for Metal Fragments
BIMBO Bakeries USA is recalling Sara Lee sesame seed hamburger buns due to the possible presence of metal fragments caused by a faulty manufacturing part.
Product
8 Bakery Buns Sara Lee Hearty & Delicious Sesame Seed and Sara Lee Gourmet Sesame Seed Hamburger Buns Restaurant Style - 12 count Sara Lee, Downers Grove, IL 60515
Category
Food
Distribution
4 states
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 (Food)·F-1570-2013·2013-07-03
BIMBO Bakeries Recalls Foodservice Hamburger Buns Due to Metal Fragments
BIMBO Bakeries USA is recalling 5,326 units of Foodservice Hamburger Buns due to possible metal fragments from a faulty manufacturing part.
Product
Foodservice Hamburger Buns - 12 Count Earthgrains Baking companies, Inc. Horsham, PA 19044
Category
Food
Distribution
4 states
HighFDA (Food)·F-1564-2013·2013-07-03
Sara Lee Classic White Hamburger Buns Recalled for Metal Fragments
BIMBO Bakeries USA is recalling Sara Lee Classic White Hamburger Buns due to possible metal fragments from a faulty manufacturing part.
Product
Sara Lee Classic White 12 Hamburger Buns Sara Lee, Downers Grove, IL 60515
Category
Food
Distribution
4 states
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 (Food)·F-1555-2013·2013-07-03
BIMBO Bakeries Recalls Colonial Cookout Enriched Buns Due to Metal Fragments
BIMBO Bakeries USA is recalling Colonial Cookout Enriched Buns due to possible metal fragments from a faulty manufacturing part.
Product
Colonial Cookout Enriched Buns - 12 count Earthgrains Baking companies, Inc. Horsham, PA 19044
Category
Food
Distribution
4 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 (Food)·F-1561-2013·2013-07-03
Kroger White Jumbo Hamburger Buns Recalled for Metal Fragment Risk
BIMBO Bakeries USA is recalling Kroger White Jumbo Hamburger Buns due to possible metal fragments from a faulty manufacturing part.
Product
Kroger White Jumbo Hamburger Buns - 8 Buns Distributed By: The Kroger Co. Cincinnati, Ohio 45202
Category
Food
Distribution
4 states
HighFDA (Food)·F-1567-2013·2013-07-03
Sunbeam Hamburger Buns Recalled for Possible Metal Fragments
BIMBO Bakeries USA is recalling Sunbeam hamburger buns due to possible metal fragments from a faulty manufacturing part at a North Carolina bakery.
Product
Sunbeam 12 Enriched Hamburger Buns and Sunbeam 12 (Seeded) Hamburger Buns Earthgrains Baking companies, Inc. Horsham, PA 19044
Category
Food
Distribution
4 states
HighFDA (Food)·F-1562-2013·2013-07-03
Kroger Sandwich Enriched Buns Recalled Due to Metal Fragment Risk
BIMBO Bakeries USA is recalling Kroger Sandwich Enriched Buns due to possible metal fragments caused by a faulty manufacturing part.
Product
Kroger Sandwich Enriched Buns - 12 count Distributed By: The Kroger Co., Cincinnati, Ohio 45202
Category
Food
Distribution
4 states
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