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.

38576–38600 of 50506

HighFDA (Devices)·Z-1665-2015·2015-06-03
United Surgical Associates Recalls Elastic Knee Supports for Missing Latex Label
United Surgical Associates is recalling 1,260 Elastic Knee Supports because they lack a caution label regarding latex content, posing a risk of allergic skin reactions.
Product
Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1653-2015·2015-06-03
Philips Brilliance CT 16 Air Recalled for Unexpected Couch Descent
Philips is recalling 153 Brilliance CT 16 Air systems because the patient couch may unexpectedly descend to its lowest point during an exam.
Product
Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-2329-2015·2015-06-03
Regency Group Recalls Ground Oregano Due to Gluten Contamination
The Regency Group is recalling 552.50 lbs of Mediterranean ground oregano because it is contaminated with gluten, a wheat allergen.
Product
Oregano, Mediterranean ground, stock code 03355, packaged in 0.2 lb., .75 lb., 0.8 lb., 1 lb., 4 lbs., 10 lbs., 15 lbs., 25 lbs., or 50 lbs. container. The UPC for 50 lbs. container is 0 23605 03355 6.
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-1689-2015·2015-06-03
Maquet Quadrox-iD Adult Diffusion Membrane Oxygenator Recalled for Blood Leakage Risk
Maquet Cardiovascular is recalling Quadrox-iD Adult Diffusion Membrane Oxygenators due to a potential issue that could result in blood leakage from the gas outlet port.
Product
Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1679-2015·2015-06-03
RaySearch RayStation Software Recalled for Dose Calculation Errors
RaySearch Laboratories AB is recalling RayStation software versions 2.5 through 4.0 due to dose calculation issues in specific VMAT plans.
Product
RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1671-2015·2015-06-03
Stryker EliteCore Biopsy Device Recalled for Cannula Overthrow Risk
Stryker is recalling EliteCore Full Core Biopsy Devices because the cannula may extend past its intended length.
Product
EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-2332-2015·2015-06-03
Regency Group Recalls French Fry Seasoning for Undeclared Wheat Allergen
Regency Group is recalling 200 lbs of French Fry Seasoning because it contains gluten (wheat) but the label does not declare wheat.
Product
French Fry Seasoning, stock code 03223, packaged in 50 lbs. container. The UPC is 0 23605 03223 8
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-1656-2015·2015-06-03
Philips Brilliance iCT CT Systems Recalled for Unexpected Couch Descent
Philips Medical Systems is recalling 153 Brilliance iCT computed tomography systems because the patient couch may unexpectedly descend during an exam.
Product
Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-2338-2015·2015-06-03
Taco Seasoning Suprema Recalled for Undeclared Wheat Allergen
Regency Group is recalling Taco Seasoning Suprema because it contains gluten (wheat) but the label does not declare wheat.
Product
Taco Seasoning Suprema, stock code 03456, packaged in 1 lb., 5 lbs., 25 lbs., or 50 lbs container. The UPC is 0 23605 03456 0
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-1672-2015·2015-06-03
DePuy LCS COMPLETE RPS Femoral Implants Recalled for Patello-femoral Pain Risk
DePuy Orthopaedics is recalling 19,059 LCS COMPLETE RPS Femoral Implants because they are associated with higher revision rates and potential patello-femoral pain when the native patella is not resurfaced.
Product
LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-2330-2015·2015-06-03
EZ's Burger Deluxe Recalled for Undeclared Wheat Allergen
Regency Group, Inc. is recalling EZ's Burger Deluxe Burger Blend due to undeclared wheat (gluten) contamination.
Product
EZ's Burger Deluxe -Burger Blend w/o MSG, stock code 12314, packaged in 50 lbs. container. No UPC.
Category
Food
Distribution
8 states
HighFDA (Food)·F-2333-2015·2015-06-03
Fresca Tomato Spice with Beet Recalled for Undeclared Wheat Allergen
Regency Group is recalling Fresca Tomato Spice with Beet due to gluten contamination and failure to declare wheat on the label.
Product
Fresca Tomato Spice with Beet, stock code 12487, packaged in 26 lbs. container. No UPC.
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-1673-2015·2015-06-03
DePuy LCS Knee Prosthesis Recalled for Higher Revision Rates
DePuy Orthopaedics is recalling LCS COMPLETE RPS knee inserts because they show higher revision rates in Australia when the patella is not resurfaced.
Product
LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1648-2015·2015-06-03
Philips Brilliance CT Big Bore Oncology Recalled for Unexpected Couch Descent
Philips Medical Systems is recalling 153 Brilliance CT Big Bore Oncology systems because the patient couch may unexpectedly descend during an exam.
Product
Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1647-2015·2015-06-03
Philips MX8000 CT Scanner Recall Due to Unexpected Couch Descent
Philips is recalling 153 MX8000 CT scanners because the patient couch may descend unexpectedly during an exam.
Product
MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1683-2015·2015-06-03
OptiMedica Catalys Precision Laser System Software Recall for Incorrect Parameters
OptiMedica is recalling Catalys Precision Laser Systems with software version 3.00.05 because a software anomaly may provide incorrect cataract surgery parameters.
Product
Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-2334-2015·2015-06-03
James Gang BBQ Bull Breath Chili Seasoning Recalled for Undeclared Wheat
Regency Group, Inc. is recalling 200 lbs of James Gang BBQ Bull Breath Chili Seasoning because it contains gluten (wheat) but the label does not declare it.
Product
James Gang BBQ Bull Breath Chili Seasoning, stock code 11523, packaged in 50 lbs. container. No UPC.
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-1680-2015·2015-06-03
GE Healthcare Recalls D-Fend Water Traps Due to Occlusion Risk
GE Healthcare is recalling D-Fend and D-Fend+ water traps because they may occlude, causing a loss of respiratory gas monitoring.
Product
D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1674-2015·2015-06-03
DePuy Spine Recalls EXPEDIUM Offset Conical Lock Nut Devices
DePuy Spine, Inc. is recalling 183 EXPEDIUM Offset Conical Lock Nut 8mm devices because they do not mate as intended.
Product
EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-2331-2015·2015-06-03
Fajita Seasoning Recalled for Undeclared Wheat Allergen
Regency Group, Inc. is recalling Fajita Seasoning because it is contaminated with gluten (wheat) and the label does not declare wheat.
Product
Fajita Seasoning, stock code 03232, packaged in 1 lb., 1.5 lbs., 5 lbs., 7 lbs., 10 lbs., 20 lbs., or 50 lbs. container. The 1 lb. container has the UPC 0 23605 03232 0.
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-1654-2015·2015-06-03
Philips Brilliance CT 10 Air Recalled for Unexpected Couch Descent
Philips Medical Systems is recalling 153 Brilliance CT 10 Air systems in China because the patient couch may unexpectedly descend during an exam.
Product
Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-2339-2015·2015-06-03
Turtle Island Roast Beef Spice Blend Recalled for Undeclared Wheat Allergen
Regency Group, Inc. is recalling Turtle Island Roast Beef Spice Blend because it is contaminated with gluten and the label does not declare wheat.
Product
Turtle Island Roast Beef Spice Blend, stock code 12690, packaged in 25 lbs.container. No UPC
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-1686-2015·2015-06-03
Medrad Stellant CT Injector System Recalled for Under-Volume Hazard
Medrad Inc dba Bayer R&I is recalling 133 Stellant CT Injector Systems with Certegra Workstations due to a configuration error that may cause under-infusion of contrast media.
Product
MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1651-2015·2015-06-03
Philips Brilliance CT 16 Power Recalled for Unexpected Couch Descent
Philips is recalling 153 Brilliance CT 16 Power systems because the patient couch may unexpectedly descend during an exam.
Product
Brilliance CT 16 Power. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1690-2015·2015-06-03
Maquet Cardiovascular Recalls HLS/HIT Set Advanced Due to Blood Leakage Risk
Maquet Cardiovascular is recalling HLS/HIT Set Advanced consoles because a potential issue could cause blood to leak from the gas outlet port.
Product
HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for…
Category
Medical Device
Distribution
Distributed nationwide