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.

41751–41775 of 50511

HighFDA (Devices)·Z-0998-2014·2014-02-26
Medtronic Recalls Select CAP Arterial Cannulae Due to Body Splitting
Medtronic is recalling Select CAP Arterial Cannulae because the cannula body may split near the suture collar. The devices are used for short-term cardiopulmonary bypass.
Product
Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Cannula consists of a curved, angled or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1539-2014·2014-02-26
Mid Pac Foods Recalls Char Sui Sauce for Undeclared Wheat
Mid Pac Foods is recalling Char Sui sauce because it contains wheat, a major allergen, that is not listed on the label.
Product
Mid Pac Foods brand sauce for Char Sui; Net 7 FL. oz (207 ml); Made in Hawaii, Keep in cool place UPC: 7336620250 Manufactured by Mid Pac Foods, Inc. Honolulu, HI.
Category
Food
Distribution
2 states
HighFDA (Food)·F-1513-2014·2014-02-26
El Encanto Recalls Bueno GC NM Hot Salsa Due to Listeria Risk
El Encanto, Incorporated is recalling Bueno GC NM Hot 5-5# Z salsa due to possible Listeria monocytogenes contamination. The product was distributed nationwide.
Product
Bueno GC NM Hot 5-5# Z, Product Item Number 1056-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1061-2014·2014-02-26
Elekta Synergy XVI Radiation Therapy System Recalled for Collision Risk
Elekta, Inc. is recalling 312 Synergy XVI radiation therapy systems due to a potential collision risk when used with external beam shaping devices.
Product
Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1519-2014·2014-02-26
El Encanto Recalls Bueno GC NM Mild Cheese for Listeria Risk
El Encanto, Incorporated is recalling Bueno GC NM Mild cheese due to possible Listeria monocytogenes contamination. The product was distributed nationwide.
Product
Bueno GC NM Mild 5-5# Z, Product Item Number 1057-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1501-2014·2014-02-26
El Encanto Recalls Bueno Mild Cheese for Listeria Risk
El Encanto, Incorporated is recalling Bueno GC NM Mild cheese due to possible Listeria monocytogenes contamination. The product was distributed nationwide.
Product
Bueno GC NM Mild 12-13 oz Z, Product Item Number 1024-1. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0987-2014·2014-02-26
B. Braun Recalls SAFSITE Injection Sites and IV Sets Due to Leakage
B. Braun Medical is recalling specific lots of SAFSITE Injection Sites and IV Sets because complaints reported leakage. The devices are used for needle-free access on IV and extension sets.
Product
SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0981-2014·2014-02-26
GE Healthcare Recalls PET Discovery Systems Due to Scatter Overcorrection
GE Healthcare is recalling PET Discovery 600, 610, 690, and 710 systems due to a potential safety issue with the List Mode Replay feature causing scatter overcorrection.
Product
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy…
Category
Medical Device
Distribution
30 states
HighCPSC·14117·2014-02-26
Cork Block Stacking Toys Recalled by A Harvest Company Due to Choking Hazard
A Harvest Company is recalling Cork Stacker block sets because small cork pieces can break off, posing a choking hazard to young children.
Product
Cork Stacker block sets
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1030-2014·2014-02-26
Zimmer Recalls ZIMTRON 6 DEG 22 Heads Due to Packaging Validation Issues
Zimmer, Inc. is recalling ZIMTRON 6 DEG 22 Heads because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Product
ZIMTRON 6 DEG 22 HEADS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1506-2014·2014-02-26
El Encanto Recalls Bueno GC NM Mild Cheese for Listeria Risk
El Encanto, Incorporated is recalling specific lots of Bueno GC NM Mild cheese due to possible Listeria monocytogenes contamination. The product was distributed nationwide.
Product
Bueno GC NM Mild 28oz Z, Product Item Number 1034-2. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 28 oz each per case totaling 10.5 lbs.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1509-2014·2014-02-26
El Encanto Recalls Bueno GC NM Exclusive XHot for Listeria Risk
El Encanto, Incorporated is recalling specific lots of Bueno GC NM Exclusive XHot due to possible Listeria monocytogenes contamination.
Product
Bueno GC NM Exclusive XHot 6-56oz Z, Product Item Number 1048-5. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 6 units of 56 oz each per case totaling 21 lbs.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1520-2014·2014-02-26
El Encanto Recalls Bueno GC NM Reserve Mild Cheese for Listeria Risk
El Encanto, Incorporated is recalling Bueno GC NM Reserve Mild cheese due to possible Listeria monocytogenes contamination. The product was distributed nationwide.
Product
Bueno GC NM Reserve Mild 5-5# Z, Product Item Number 1057-4. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1527-2104·2014-02-26
El Encanto Recalls Bueno GC Strip Hot Due to Listeria Risk
El Encanto, Incorporated is recalling Bueno GC Strip Hot due to possible Listeria monocytogenes contamination. The product was distributed nationwide, including to military and government consignees.
Product
Bueno GC Strip Hot 2-12.5# Z, Product Item Number 1072-4. Packaged in double-poly bags.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1045-2014·2014-02-26
Biosense Webster Recalls CartoUnivu Module for Map Misalignment
Biosense Webster is recalling the CartoUnivu Module for the Carto 3 System due to potential misalignment between the map display and fluoroscopic images.
Product
CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN…
Category
Medical Device
Distribution
5 states
HighFDA (Food)·F-1515-2014·2014-02-26
El Encanto Recalls Hatch Valley Hot Salsa Due to Listeria Risk
El Encanto, Incorporated is recalling specific lots of Hatch Valley Hot salsa due to possible Listeria monocytogenes contamination. The product was distributed nationwide.
Product
Bueno GC NM Hatch Valley Hot 5-5# Z, Product Item Number 1056-5. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1525-2014·2014-02-26
El Encanto Autumn Roast Hot Pepper Recall for Listeria Risk
El Encanto, Incorporated is recalling Bueno GC NM Autumn Roast Hot peppers due to possible Listeria monocytogenes contamination.
Product
Bueno GC NM Autumn Roast Hot 5-5# Z, Product Item Number 1062-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1533-2014·2014-02-26
El Encanto Recalls Bueno GC 1.5 Hot Salsa for Listeria Risk
El Encanto, Incorporated is recalling Bueno GC 1.5 Hot 5-5# Z salsa due to possible Listeria monocytogenes contamination. The product was distributed nationwide.
Product
Bueno GC 1.5 Hot 5-5# Z, Product Item Number 1096-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1511-2014·2014-02-26
El Encanto Recalls Hot Salsa for Possible Listeria Contamination
El Encanto, Incorporated is recalling GC NO LABEL Hot 5-5# Z due to possible Listeria monocytogenes contamination. The product was distributed nationwide.
Product
GC NO LABEL Hot 5-5# Z, Product Item Number 1056-0. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1531-2014·2014-02-26
El Encanto Autumn Roast Strip Beef Recalled for Listeria Risk
El Encanto, Incorporated is recalling specific lots of Bueno GC Autumn Roast Strip Medium beef due to possible Listeria monocytogenes contamination.
Product
Bueno GC Autumn Roast Strip Medium 2-12.5# Z, Product Item Number 1090-5. Packaged in double-poly bags and not sealed.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1026-2014·2014-02-26
Zimmer Recalls HGP II Acetabular Cup Due to Packaging Validation Issues
Zimmer is recalling HGP II Acetabular Cup Mod units because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Product
HGP II ACETABULAR CUP MOD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1510-2014·2014-02-26
El Encanto GC Medium 5-5# Z Recalled for Listeria Risk
El Encanto, Incorporated is recalling GC Medium 5-5# Z due to possible Listeria monocytogenes contamination. The product was distributed nationwide.
Product
GC Medium 5-5# Z, Product Item Number 1055-3. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1057-2014·2014-02-26
Synthes Driving Cap/Threaded Recalled for Binding in Insertion Handles
Synthes, Inc. is recalling 143 units of the Driving Cap/Threaded because the parts can bind in insertion handles, making them difficult to separate.
Product
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1512-2014·2014-02-26
El Encanto GC Exclusive Hot 5-5# Z Recalled for Listeria Risk
El Encanto, Incorporated is recalling GC Exclusive Hot 5-5# Z due to possible Listeria monocytogenes contamination. The product was distributed nationwide.
Product
GC Exclusive Hot 5-5# Z, Product Item Number 1056-2. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1522-2014·2014-02-26
El Encanto Recalls Bueno GC NM Mild Cheese for Listeria Risk
El Encanto, Incorporated is recalling Bueno GC NM Mild cheese due to possible Listeria monocytogenes contamination. The product was distributed nationwide.
Product
Bueno GC NM Mild 5-5# Z, Product Item Number 1057-7. Packaged in sealed poly film pouches. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size 5 units of 5 lbs each per case, totaling 25 lbs.
Category
Food
Distribution
Distributed nationwide